38 Medical Writing jobs in the United Kingdom
Medical Writing Manager (Regulatory Writing)
Reading, South East
IQVIA
Posted 13 days ago
Job Viewed
Job Description
**Job Overview**
Acts as Lead Medical Writer on any type of writing project, including projects with multiple deliverables/components. Prepares assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines. Performs senior review of all types of medical writing deliverables. Provides feedback and guidance to more junior staff. Negotiates timelines and discusses/resolves customer comments. Keeps abreast of current medical and/or technical writing/regulatory knowledge, including Good Clinical Practice (GCP), along with developments and advances in drug development/medical and/or technical writing.
**Essential Functions**
+ Take a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating and adhering to timelines, organizing document reviews, communicating directly with the customer.
+ Plan and organize workload for assigned projects and tasks: identify project needs, track timelines and implement customer requests.
+ Use experience and initiative to tackle new/unusual document types and customer requirements.
+ Lead meetings on more challenging topics independently and act as point of contact for escalations and resolve conflict.
+ Participate in bid defense meetings and discussions.
+ May design training materials and input into generic training plans for staff. Proposes topics for and prepares and delivers knowledge-sharing sessions for the global team. May propose, plan and deliver general training on Medical Writing to other IQVIA groups and externally, as appropriate.
+ May act as Project Manager for a more complex but single Medical Writing project which includes Project Finance/Invoicing responsibilities.
+ Complete project finance activities, including monitoring and forecasting budgeted hours.
+ Independently propose, review and approve budgets and assumptions for a range of project types within remit.
+ May take on a partnership lead role.
+ Likely to represent region or site on a Medical Writing initiative or cross-functional initiative.
+ May draft new Medical Writing Standard Operating Procedures (SOPs) for review and act as reviewer for Medical Writing SOPs, as assigned and appropriate.
**Qualifications and Experience and Skills**
+ Bachelor's Degree n life sciences related discipline or related field required
+ Master's Degree in life sciences related discipline or related field preferred
+ Ph.D. in life sciences related discipline or related field preferred
+ Typically requires at least 7 years of highly relevant experience in regulatory writing and related competency levels.
+ In-depth knowledge of the structural and content requirements of clinical study reports (CSR), Common Technical Documents (CTD), protocols, and similar documents and ability to identify deficiencies, errors, and inconsistencies in a protocol or report.
+ Experienced in preparing CTDs and/or tackling new/unusual document types/customer requirements.
+ Good understanding of common statistical methods used in clinical trials and/or interpretation of their results.
+ Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output
+ Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.
+ Significant experience as a lead writer in preparing CSRs, CTDs and protocols, with consistently positive feedback from customers and colleagues.
+ In depth knowledge of drug development, medical writing, and associated regulations.
+ Good understanding of statistical principles and of medical terminology across a range of therapeutic areas.
**Skills and Abilities**
+ Excellent written and oral communication skills including grammatical/technical writing skills.
+ Excellent attention to detail and accuracy.
+ Confident and effective communication and negotiation skills with customers and project managers.
+ Demonstrated ability to remain calm and assertive yet diplomatic in more challenging interactions with customers and colleagues.
+ Demonstrates initiative and sound judgement when faced with less familiar project/document situations or challenges.
+ Demonstrated abilities in collaboration with others and independent thought.
+ Demonstrated ability to influence others without having official authority.
+ Demonstrates good judgement in requesting input from senior staff.
+ Demonstrates confidence and maturity in most routine medical writing situations.
+ Ability to establish and maintain effective working relationships with coworkers, managers and customers.
+ Ability to effectively manage multiple tasks and projects.
+ Ability to proactively evaluate risks and potential issues and seek solutions and discuss appropriately with colleagues and customers.
+ Confidence in appropriately challenging the customer when document quality or timelines are at risk.
+ Must be computer literate.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Acts as Lead Medical Writer on any type of writing project, including projects with multiple deliverables/components. Prepares assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines. Performs senior review of all types of medical writing deliverables. Provides feedback and guidance to more junior staff. Negotiates timelines and discusses/resolves customer comments. Keeps abreast of current medical and/or technical writing/regulatory knowledge, including Good Clinical Practice (GCP), along with developments and advances in drug development/medical and/or technical writing.
**Essential Functions**
+ Take a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating and adhering to timelines, organizing document reviews, communicating directly with the customer.
+ Plan and organize workload for assigned projects and tasks: identify project needs, track timelines and implement customer requests.
+ Use experience and initiative to tackle new/unusual document types and customer requirements.
+ Lead meetings on more challenging topics independently and act as point of contact for escalations and resolve conflict.
+ Participate in bid defense meetings and discussions.
+ May design training materials and input into generic training plans for staff. Proposes topics for and prepares and delivers knowledge-sharing sessions for the global team. May propose, plan and deliver general training on Medical Writing to other IQVIA groups and externally, as appropriate.
+ May act as Project Manager for a more complex but single Medical Writing project which includes Project Finance/Invoicing responsibilities.
+ Complete project finance activities, including monitoring and forecasting budgeted hours.
+ Independently propose, review and approve budgets and assumptions for a range of project types within remit.
+ May take on a partnership lead role.
+ Likely to represent region or site on a Medical Writing initiative or cross-functional initiative.
+ May draft new Medical Writing Standard Operating Procedures (SOPs) for review and act as reviewer for Medical Writing SOPs, as assigned and appropriate.
**Qualifications and Experience and Skills**
+ Bachelor's Degree n life sciences related discipline or related field required
+ Master's Degree in life sciences related discipline or related field preferred
+ Ph.D. in life sciences related discipline or related field preferred
+ Typically requires at least 7 years of highly relevant experience in regulatory writing and related competency levels.
+ In-depth knowledge of the structural and content requirements of clinical study reports (CSR), Common Technical Documents (CTD), protocols, and similar documents and ability to identify deficiencies, errors, and inconsistencies in a protocol or report.
+ Experienced in preparing CTDs and/or tackling new/unusual document types/customer requirements.
+ Good understanding of common statistical methods used in clinical trials and/or interpretation of their results.
+ Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output
+ Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.
+ Significant experience as a lead writer in preparing CSRs, CTDs and protocols, with consistently positive feedback from customers and colleagues.
+ In depth knowledge of drug development, medical writing, and associated regulations.
+ Good understanding of statistical principles and of medical terminology across a range of therapeutic areas.
**Skills and Abilities**
+ Excellent written and oral communication skills including grammatical/technical writing skills.
+ Excellent attention to detail and accuracy.
+ Confident and effective communication and negotiation skills with customers and project managers.
+ Demonstrated ability to remain calm and assertive yet diplomatic in more challenging interactions with customers and colleagues.
+ Demonstrates initiative and sound judgement when faced with less familiar project/document situations or challenges.
+ Demonstrated abilities in collaboration with others and independent thought.
+ Demonstrated ability to influence others without having official authority.
+ Demonstrates good judgement in requesting input from senior staff.
+ Demonstrates confidence and maturity in most routine medical writing situations.
+ Ability to establish and maintain effective working relationships with coworkers, managers and customers.
+ Ability to effectively manage multiple tasks and projects.
+ Ability to proactively evaluate risks and potential issues and seek solutions and discuss appropriately with colleagues and customers.
+ Confidence in appropriately challenging the customer when document quality or timelines are at risk.
+ Must be computer literate.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
This advertiser has chosen not to accept applicants from your region.
0
Senior Manager/Associate Director Medical Writing,Immunology
High Wycombe, South East
J&J Family of Companies
Posted 1 day ago
Job Viewed
Job Description
At Johnson & Johnson,u202fwe believe health is everything. Our strength in healthcare innovation empowers us to build au202fworld where complex diseases are prevented, treated, and cured,u202fwhere treatments are smarter and less invasive, andu202fsolutions are personal.u202fThrough our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.u202fLearn more at
**Job Function:**
Medical Affairs Group
**Job Sub** **Function:**
Medical Writing
**Job Category:**
People Leader
**All Job Posting Locations:**
High Wycombe, Buckinghamshire, United Kingdom
**Job Description:**
At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time.
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at
We are searching for the best talent for a **Senior Manager/Associate Director** , **Regulatory Medical Writing** within our Integrated Data Analytics & Reporting (IDAR) business. This role will support our Immunology Regulatory Medical Writing area.
**The position can be located at any of our following offices: High Wycombe (UK), Beerse (Belgium), Leiden (Netherlands), Allschwil (Switzerland), or Spring House/Raritan/Titusville (East Coast US).**
Hybrid (3 days per week onsite) is strongly preferred. Remote work options may be considered on a case-by-case basis and if approved by the company.
You will be responsible for:
Leading compound/submission/indication/disease area writing teams independently.
Directly leading or setting objectives for others on team projects and tasks, eg, able to lead Medical Writing (MW) process working groups or Communities of Practice.
Writing or coordinating all types of clinical and regulatory documents, taking a proactive or lead role in terms of content and scientific strategy.
Establishing and driving document timelines and strategies independently.
Guiding or training cross-functional team members on processes and best practices.
Proactively identifying and championing departmental process improvements.
May lead cross-functional, cross-therapy area, or cross-J&J process improvement initiatives.
Leading discussions in MW and cross-functional meetings as appropriate (eg, submission team meetings, Global Program Team meetings, study team meetings, clinical team meetings).
Maintaining and disseminating knowledge of industry, company, and regulatory guidelines.
Interacting with senior cross-functional colleagues and external partners to strengthen coordination between departments.
As a people manager:
Supervising/managing and being accountable for direct reports.
Setting objectives and agreeing on goals for direct reports. Providing performance oversight, including feedback on performance and development.
Regularly meeting with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
Coaching or mentoring more junior writers on document planning, processes, content, and provides peer review as needed.
Ensuring direct reportu2019s adherence to established policies, procedural documents, and templates.
Participating in hiring staff, onboarding new staff, conducting career and talent development discussions for staff, goal-setting, end-of-year performance reviews, and compensation planning.
Qualifications /Requirements:
A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred.
At least 10 years of relevant pharmaceutical/scientific experience.
At least 8 years of relevant clinical/regulatory medical writing experience.
At least 2 years of direct people management experience.
Experience in project management and process improvement.
Advanced knowledge and application of regulatory guidance such as ICH requirements
Recognizes how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
Resolves complex problems independently.
Proactively identifies potential risks and develops strategies to mitigate.
Ability to serve as the liaison between team members and senior leadership within a therapy area.
Ability to build and maintain solid and positive relationships with cross-functional team members.
Excellent oral and written communication skills.
Attention to detail.
Expert time management for self and team.
Expert project management skills, expert project/process leadership.
Strong leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management).
Ability to delegate responsibility to junior writers.
Ability to lead by example, stay focused and positive, and act with integrity.
Ability to internalize and teach CREDO behaviours.
Ability to act as change agent and adapt to rapidly changing organizational & business challenges.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
United Kingdom - Requisition Number: R-
Belgium, Netherlands - Requisition Number: R-
Switzerland - Requisition Number: R-
United States - Requisition Number: R-
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
**For United States applicants:**
The anticipated base pay range for this position is $137,000 to $235,750 (USD).
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporationu2019s performance over a calendar/ performance year. Bonuses are awarded at the Companyu2019s discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Companyu2019s consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
- Vacation - up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on company benefits, please go to:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
#LI-Hybrid
#LI-Remote
**Job Function:**
Medical Affairs Group
**Job Sub** **Function:**
Medical Writing
**Job Category:**
People Leader
**All Job Posting Locations:**
High Wycombe, Buckinghamshire, United Kingdom
**Job Description:**
At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time.
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at
We are searching for the best talent for a **Senior Manager/Associate Director** , **Regulatory Medical Writing** within our Integrated Data Analytics & Reporting (IDAR) business. This role will support our Immunology Regulatory Medical Writing area.
**The position can be located at any of our following offices: High Wycombe (UK), Beerse (Belgium), Leiden (Netherlands), Allschwil (Switzerland), or Spring House/Raritan/Titusville (East Coast US).**
Hybrid (3 days per week onsite) is strongly preferred. Remote work options may be considered on a case-by-case basis and if approved by the company.
You will be responsible for:
Leading compound/submission/indication/disease area writing teams independently.
Directly leading or setting objectives for others on team projects and tasks, eg, able to lead Medical Writing (MW) process working groups or Communities of Practice.
Writing or coordinating all types of clinical and regulatory documents, taking a proactive or lead role in terms of content and scientific strategy.
Establishing and driving document timelines and strategies independently.
Guiding or training cross-functional team members on processes and best practices.
Proactively identifying and championing departmental process improvements.
May lead cross-functional, cross-therapy area, or cross-J&J process improvement initiatives.
Leading discussions in MW and cross-functional meetings as appropriate (eg, submission team meetings, Global Program Team meetings, study team meetings, clinical team meetings).
Maintaining and disseminating knowledge of industry, company, and regulatory guidelines.
Interacting with senior cross-functional colleagues and external partners to strengthen coordination between departments.
As a people manager:
Supervising/managing and being accountable for direct reports.
Setting objectives and agreeing on goals for direct reports. Providing performance oversight, including feedback on performance and development.
Regularly meeting with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
Coaching or mentoring more junior writers on document planning, processes, content, and provides peer review as needed.
Ensuring direct reportu2019s adherence to established policies, procedural documents, and templates.
Participating in hiring staff, onboarding new staff, conducting career and talent development discussions for staff, goal-setting, end-of-year performance reviews, and compensation planning.
Qualifications /Requirements:
A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred.
At least 10 years of relevant pharmaceutical/scientific experience.
At least 8 years of relevant clinical/regulatory medical writing experience.
At least 2 years of direct people management experience.
Experience in project management and process improvement.
Advanced knowledge and application of regulatory guidance such as ICH requirements
Recognizes how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
Resolves complex problems independently.
Proactively identifies potential risks and develops strategies to mitigate.
Ability to serve as the liaison between team members and senior leadership within a therapy area.
Ability to build and maintain solid and positive relationships with cross-functional team members.
Excellent oral and written communication skills.
Attention to detail.
Expert time management for self and team.
Expert project management skills, expert project/process leadership.
Strong leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management).
Ability to delegate responsibility to junior writers.
Ability to lead by example, stay focused and positive, and act with integrity.
Ability to internalize and teach CREDO behaviours.
Ability to act as change agent and adapt to rapidly changing organizational & business challenges.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
United Kingdom - Requisition Number: R-
Belgium, Netherlands - Requisition Number: R-
Switzerland - Requisition Number: R-
United States - Requisition Number: R-
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
**For United States applicants:**
The anticipated base pay range for this position is $137,000 to $235,750 (USD).
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporationu2019s performance over a calendar/ performance year. Bonuses are awarded at the Companyu2019s discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Companyu2019s consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
- Vacation - up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on company benefits, please go to:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
#LI-Hybrid
#LI-Remote
This advertiser has chosen not to accept applicants from your region.
1
Senior Manager/Associate Director Medical Writing,Immunology
High Wycombe, South East
J&J Family of Companies
Posted 1 day ago
Job Viewed
Job Description
At Johnson & Johnson,u202fwe believe health is everything. Our strength in healthcare innovation empowers us to build au202fworld where complex diseases are prevented, treated, and cured,u202fwhere treatments are smarter and less invasive, andu202fsolutions are personal.u202fThrough our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.u202fLearn more at
**Job Function:**
Medical Affairs Group
**Job Sub** **Function:**
Medical Writing
**Job Category:**
People Leader
**All Job Posting Locations:**
High Wycombe, Buckinghamshire, United Kingdom
**Job Description:**
At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time.
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at
We are searching for the best talent for a **Senior Manager/Associate Director** , **Regulatory Medical Writing** within our Integrated Data Analytics & Reporting (IDAR) business. This role will support our Immunology Regulatory Medical Writing area.
**The position can be located at any of our following offices: High Wycombe (UK), Beerse (Belgium), Leiden (Netherlands), Allschwil (Switzerland), or Spring House/Raritan/Titusville (East Coast US).**
Hybrid (3 days per week onsite) is strongly preferred. Remote work options may be considered on a case-by-case basis and if approved by the company.
You will be responsible for:
Leading compound/submission/indication/disease area writing teams independently.
Directly leading or setting objectives for others on team projects and tasks, eg, able to lead Medical Writing (MW) process working groups or Communities of Practice.
Writing or coordinating all types of clinical and regulatory documents, taking a proactive or lead role in terms of content and scientific strategy.
Establishing and driving document timelines and strategies independently.
Guiding or training cross-functional team members on processes and best practices.
Proactively identifying and championing departmental process improvements.
May lead cross-functional, cross-therapy area, or cross-J&J process improvement initiatives.
Leading discussions in MW and cross-functional meetings as appropriate (eg, submission team meetings, Global Program Team meetings, study team meetings, clinical team meetings).
Maintaining and disseminating knowledge of industry, company, and regulatory guidelines.
Interacting with senior cross-functional colleagues and external partners to strengthen coordination between departments.
As a people manager:
Supervising/managing and being accountable for direct reports.
Setting objectives and agreeing on goals for direct reports. Providing performance oversight, including feedback on performance and development.
Regularly meeting with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
Coaching or mentoring more junior writers on document planning, processes, content, and provides peer review as needed.
Ensuring direct reportu2019s adherence to established policies, procedural documents, and templates.
Participating in hiring staff, onboarding new staff, conducting career and talent development discussions for staff, goal-setting, end-of-year performance reviews, and compensation planning.
Qualifications /Requirements:
A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred.
At least 10 years of relevant pharmaceutical/scientific experience.
At least 8 years of relevant clinical/regulatory medical writing experience.
At least 2 years of direct people management experience.
Experience in project management and process improvement.
Advanced knowledge and application of regulatory guidance such as ICH requirements
Recognizes how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
Resolves complex problems independently.
Proactively identifies potential risks and develops strategies to mitigate.
Ability to serve as the liaison between team members and senior leadership within a therapy area.
Ability to build and maintain solid and positive relationships with cross-functional team members.
Excellent oral and written communication skills.
Attention to detail.
Expert time management for self and team.
Expert project management skills, expert project/process leadership.
Strong leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management).
Ability to delegate responsibility to junior writers.
Ability to lead by example, stay focused and positive, and act with integrity.
Ability to internalize and teach CREDO behaviours.
Ability to act as change agent and adapt to rapidly changing organizational & business challenges.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
United Kingdom - Requisition Number: R-
Belgium, Netherlands - Requisition Number: R-
Switzerland - Requisition Number: R-
United States - Requisition Number: R-
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
**For United States applicants:**
The anticipated base pay range for this position is $137,000 to $235,750 (USD).
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporationu2019s performance over a calendar/ performance year. Bonuses are awarded at the Companyu2019s discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Companyu2019s consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
- Vacation - up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on company benefits, please go to:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
#LI-Hybrid
#LI-Remote
**Job Function:**
Medical Affairs Group
**Job Sub** **Function:**
Medical Writing
**Job Category:**
People Leader
**All Job Posting Locations:**
High Wycombe, Buckinghamshire, United Kingdom
**Job Description:**
At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time.
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at
We are searching for the best talent for a **Senior Manager/Associate Director** , **Regulatory Medical Writing** within our Integrated Data Analytics & Reporting (IDAR) business. This role will support our Immunology Regulatory Medical Writing area.
**The position can be located at any of our following offices: High Wycombe (UK), Beerse (Belgium), Leiden (Netherlands), Allschwil (Switzerland), or Spring House/Raritan/Titusville (East Coast US).**
Hybrid (3 days per week onsite) is strongly preferred. Remote work options may be considered on a case-by-case basis and if approved by the company.
You will be responsible for:
Leading compound/submission/indication/disease area writing teams independently.
Directly leading or setting objectives for others on team projects and tasks, eg, able to lead Medical Writing (MW) process working groups or Communities of Practice.
Writing or coordinating all types of clinical and regulatory documents, taking a proactive or lead role in terms of content and scientific strategy.
Establishing and driving document timelines and strategies independently.
Guiding or training cross-functional team members on processes and best practices.
Proactively identifying and championing departmental process improvements.
May lead cross-functional, cross-therapy area, or cross-J&J process improvement initiatives.
Leading discussions in MW and cross-functional meetings as appropriate (eg, submission team meetings, Global Program Team meetings, study team meetings, clinical team meetings).
Maintaining and disseminating knowledge of industry, company, and regulatory guidelines.
Interacting with senior cross-functional colleagues and external partners to strengthen coordination between departments.
As a people manager:
Supervising/managing and being accountable for direct reports.
Setting objectives and agreeing on goals for direct reports. Providing performance oversight, including feedback on performance and development.
Regularly meeting with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
Coaching or mentoring more junior writers on document planning, processes, content, and provides peer review as needed.
Ensuring direct reportu2019s adherence to established policies, procedural documents, and templates.
Participating in hiring staff, onboarding new staff, conducting career and talent development discussions for staff, goal-setting, end-of-year performance reviews, and compensation planning.
Qualifications /Requirements:
A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred.
At least 10 years of relevant pharmaceutical/scientific experience.
At least 8 years of relevant clinical/regulatory medical writing experience.
At least 2 years of direct people management experience.
Experience in project management and process improvement.
Advanced knowledge and application of regulatory guidance such as ICH requirements
Recognizes how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
Resolves complex problems independently.
Proactively identifies potential risks and develops strategies to mitigate.
Ability to serve as the liaison between team members and senior leadership within a therapy area.
Ability to build and maintain solid and positive relationships with cross-functional team members.
Excellent oral and written communication skills.
Attention to detail.
Expert time management for self and team.
Expert project management skills, expert project/process leadership.
Strong leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management).
Ability to delegate responsibility to junior writers.
Ability to lead by example, stay focused and positive, and act with integrity.
Ability to internalize and teach CREDO behaviours.
Ability to act as change agent and adapt to rapidly changing organizational & business challenges.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
United Kingdom - Requisition Number: R-
Belgium, Netherlands - Requisition Number: R-
Switzerland - Requisition Number: R-
United States - Requisition Number: R-
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
**For United States applicants:**
The anticipated base pay range for this position is $137,000 to $235,750 (USD).
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporationu2019s performance over a calendar/ performance year. Bonuses are awarded at the Companyu2019s discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Companyu2019s consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
- Vacation - up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on company benefits, please go to:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
#LI-Hybrid
#LI-Remote
This advertiser has chosen not to accept applicants from your region.
2
Senior Manager/Associate Director Medical Writing, Immunology
High Wycombe, South East
J&J Family of Companies
Posted today
Job Viewed
Job Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
Medical Affairs Group
**Job Sub** **Function:**
Medical Writing
**Job Category:**
People Leader
**All Job Posting Locations:**
High Wycombe, Buckinghamshire, United Kingdom
**Job Description:**
At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time.
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at are searching for the best talent for a **Senior Manager/Associate Director** , **Regulatory Medical Writing** within our Integrated Data Analytics & Reporting (IDAR) business. This role will support our Immunology Regulatory Medical Writing area.
**The position can be located at any of our following offices: High Wycombe (UK), Beerse (Belgium), Leiden (Netherlands), Allschwil (Switzerland), or Spring House/Raritan/Titusville (East Coast US).**
Hybrid (3 days per week onsite) is strongly preferred. Remote work options may be considered on a case-by-case basis and if approved by the company.
You will be responsible for:
+ Leading compound/submission/indication/disease area writing teams independently.
+ Directly leading or setting objectives for others on team projects and tasks, eg, able to lead Medical Writing (MW) process working groups or Communities of Practice.
+ Writing or coordinating all types of clinical and regulatory documents, taking a proactive or lead role in terms of content and scientific strategy.
+ Establishing and driving document timelines and strategies independently.
+ Guiding or training cross-functional team members on processes and best practices.
+ Proactively identifying and championing departmental process improvements.
+ May lead cross-functional, cross-therapy area, or cross-J&J process improvement initiatives.
+ Leading discussions in MW and cross-functional meetings as appropriate (eg, submission team meetings, Global Program Team meetings, study team meetings, clinical team meetings).
+ Maintaining and disseminating knowledge of industry, company, and regulatory guidelines.
+ Interacting with senior cross-functional colleagues and external partners to strengthen coordination between departments.
As a people manager:
+ Supervising/managing and being accountable for direct reports.
+ Setting objectives and agreeing on goals for direct reports. Providing performance oversight, including feedback on performance and development.
+ Regularly meeting with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
+ Coaching or mentoring more junior writers on document planning, processes, content, and provides peer review as needed.
+ Ensuring direct report's adherence to established policies, procedural documents, and templates.
+ Participating in hiring staff, onboarding new staff, conducting career and talent development discussions for staff, goal-setting, end-of-year performance reviews, and compensation planning.
Qualifications /Requirements:
+ A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred.
+ At least 10 years of relevant pharmaceutical/scientific experience.
+ At least 8 years of relevant clinical/regulatory medical writing experience.
+ At least 2 years of direct people management experience.
+ Experience in project management and process improvement.
+ Advanced knowledge and application of regulatory guidance such as ICH requirements
+ Recognizes how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
+ Resolves complex problems independently.
+ Proactively identifies potential risks and develops strategies to mitigate.
+ Ability to serve as the liaison between team members and senior leadership within a therapy area.
+ Ability to build and maintain solid and positive relationships with cross-functional team members.
+ Excellent oral and written communication skills.
+ Attention to detail.
+ Expert time management for self and team.
+ Expert project management skills, expert project/process leadership.
+ Strong leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management).
+ Ability to delegate responsibility to junior writers.
+ Ability to lead by example, stay focused and positive, and act with integrity.
+ Ability to internalize and teach CREDO behaviours.
+ Ability to act as change agent and adapt to rapidly changing organizational & business challenges.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
+ United Kingdom - Requisition Number: R-
+ Belgium, Netherlands - Requisition Number: R-
+ Switzerland - Requisition Number: R-
+ United States - Requisition Number: R-
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
**For United States applicants:**
The anticipated base pay range for this position is $137,000 to $235,750 (USD).
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
- Vacation - up to 120 hours per calendar year
+ Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on company benefits, please go to: compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
#LI-Hybrid
#LI-Remote
Medical Affairs Group
**Job Sub** **Function:**
Medical Writing
**Job Category:**
People Leader
**All Job Posting Locations:**
High Wycombe, Buckinghamshire, United Kingdom
**Job Description:**
At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time.
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at are searching for the best talent for a **Senior Manager/Associate Director** , **Regulatory Medical Writing** within our Integrated Data Analytics & Reporting (IDAR) business. This role will support our Immunology Regulatory Medical Writing area.
**The position can be located at any of our following offices: High Wycombe (UK), Beerse (Belgium), Leiden (Netherlands), Allschwil (Switzerland), or Spring House/Raritan/Titusville (East Coast US).**
Hybrid (3 days per week onsite) is strongly preferred. Remote work options may be considered on a case-by-case basis and if approved by the company.
You will be responsible for:
+ Leading compound/submission/indication/disease area writing teams independently.
+ Directly leading or setting objectives for others on team projects and tasks, eg, able to lead Medical Writing (MW) process working groups or Communities of Practice.
+ Writing or coordinating all types of clinical and regulatory documents, taking a proactive or lead role in terms of content and scientific strategy.
+ Establishing and driving document timelines and strategies independently.
+ Guiding or training cross-functional team members on processes and best practices.
+ Proactively identifying and championing departmental process improvements.
+ May lead cross-functional, cross-therapy area, or cross-J&J process improvement initiatives.
+ Leading discussions in MW and cross-functional meetings as appropriate (eg, submission team meetings, Global Program Team meetings, study team meetings, clinical team meetings).
+ Maintaining and disseminating knowledge of industry, company, and regulatory guidelines.
+ Interacting with senior cross-functional colleagues and external partners to strengthen coordination between departments.
As a people manager:
+ Supervising/managing and being accountable for direct reports.
+ Setting objectives and agreeing on goals for direct reports. Providing performance oversight, including feedback on performance and development.
+ Regularly meeting with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
+ Coaching or mentoring more junior writers on document planning, processes, content, and provides peer review as needed.
+ Ensuring direct report's adherence to established policies, procedural documents, and templates.
+ Participating in hiring staff, onboarding new staff, conducting career and talent development discussions for staff, goal-setting, end-of-year performance reviews, and compensation planning.
Qualifications /Requirements:
+ A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred.
+ At least 10 years of relevant pharmaceutical/scientific experience.
+ At least 8 years of relevant clinical/regulatory medical writing experience.
+ At least 2 years of direct people management experience.
+ Experience in project management and process improvement.
+ Advanced knowledge and application of regulatory guidance such as ICH requirements
+ Recognizes how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
+ Resolves complex problems independently.
+ Proactively identifies potential risks and develops strategies to mitigate.
+ Ability to serve as the liaison between team members and senior leadership within a therapy area.
+ Ability to build and maintain solid and positive relationships with cross-functional team members.
+ Excellent oral and written communication skills.
+ Attention to detail.
+ Expert time management for self and team.
+ Expert project management skills, expert project/process leadership.
+ Strong leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management).
+ Ability to delegate responsibility to junior writers.
+ Ability to lead by example, stay focused and positive, and act with integrity.
+ Ability to internalize and teach CREDO behaviours.
+ Ability to act as change agent and adapt to rapidly changing organizational & business challenges.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
+ United Kingdom - Requisition Number: R-
+ Belgium, Netherlands - Requisition Number: R-
+ Switzerland - Requisition Number: R-
+ United States - Requisition Number: R-
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
**For United States applicants:**
The anticipated base pay range for this position is $137,000 to $235,750 (USD).
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
- Vacation - up to 120 hours per calendar year
+ Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on company benefits, please go to: compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
#LI-Hybrid
#LI-Remote
This advertiser has chosen not to accept applicants from your region.
3
Senior Manager/Associate Director,Regulatory Medical Writing X-TA
High Wycombe, South East
J&J Family of Companies
Posted 8 days ago
Job Viewed
Job Description
At Johnson & Johnson,u202fwe believe health is everything. Our strength in healthcare innovation empowers us to build au202fworld where complex diseases are prevented, treated, and cured,u202fwhere treatments are smarter and less invasive, andu202fsolutions are personal.u202fThrough our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.u202fLearn more at
**Job Function:**
Medical Affairs Group
**Job Sub** **Function:**
Medical Writing
**Job Category:**
People Leader
**All Job Posting Locations:**
High Wycombe, Buckinghamshire, United Kingdom
**Job Description:**
**Senior Manager/Associate Director, Regulatory Medical Writing X-TA**
At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time.
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at
We are searching for the best talent for a **Senior Manager** **/Associate Director** , **Regulatory Medical Writing** within our Integrated Data Analytics & Reporting (IDAR) business. This role will support one or more of our therapeutic areas within the X-TA (Cross Therapeutic Area) Regulatory Medical Writing area.
**The position can be** **located** **at any of our following offices: High Wycombe (UK), Beerse (Belgium), Leiden (Netherlands),** **Allschwil** **(Switzerland) or Spring House/Raritan/Titusville (East Coast US).**
Hybrid (3 days per week onsite) is strongly preferred. Remote work options may be considered on a case-by-case basis and if approved by the company.
_Are you ready to join our team? Then please read further!_
**You will** **be responsible for** **:**
Leading compound/submission/indication/disease area writing teams independently.
May have additional major responsibility with supervision.
Cross-functional, cross-TA, or cross-J&J initiative/collaboration.
Larger organizational responsibility (eg, manage a subset of TA).
Preparing and finalizing all types of clinical documents, taking a proactive or lead role in terms of content and scientific strategy. Working with a high level of independence and taking a lead role on with respect to timing, scheduling, and tracking.
Leading program-level/submission writing teams independently.
Directly leading or setting objectives for others on team projects and tasks.
Guiding or training crossu2010functional team members on processes, best practices; coach or mentor more junior writers.
Proactively identifying, contributing to and championing Medical Writing process improvements, internal standards, regulatory, and publishing guidelines, internal systems, tools, and processes.
Leading crossu2010functional/crossu2010TA, crossu2010J&J process improvement initiatives, or other large process working groups.
Developing, maintaining and disseminating knowledge of industry, company, and regulatory guidelines to internal and external audiences.
If a lead writer for a program:
Primary point of contact and champion for Medical Writing activities for the clinical team.
Responsible for planning and leading the writing group for assigned program.
Able to function as a lead writer on any compound independently.
Leading discussions in Medical Writing and crossu2010functional meetings as appropriate.
Interacting with senior crossu2010functional colleagues and external partners to strengthen coordination between departments.
Able to oversee the work of external contractors.
As a people manager:
Manage direct reports in Medical Writing.
Set objectives for individual team members. Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
Ensures direct reportu2019s adherence to established policies, procedural documents, and templates
Able to make decision on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, lead in goal setting and performance discussions.
**Qualifications /Requirements:**
University/college degree in a scientific discipline is required. Masters or PhD preferred.
At least 10 years of relevant pharmaceutical/scientific experience; at least 8 years of relevant Medical Writing experience is required!
At least 2 years of people management experience.
Multiple therapeutic area experience preferred.
Strong attention to detail.
Strong oral and written communication skills. Fluent written and spoken English.
Expert project management skills, expert project/process improvement leadership.
Expert leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management). Strong people management skills.
Ability to delegate responsibility to junior writers.
Demonstrated ability to collaborate and develop effective partnerships with key business partners and customers.
Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
United Kingdom - Requisition Number: R-
Belgium, Netherlands - Requisition Number: R-
Switzerland - Requisition Number: R-
United States - Requisition Number: R-
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
**For United States applicants:**
The anticipated base pay range for this position is $137,000 to $235,750 (USD).
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporationu2019s performance over a calendar/ performance year. Bonuses are awarded at the Companyu2019s discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Companyu2019s consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
- Vacation - up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on company benefits, please go to:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
#LI-Hybrid
#LI-Remote
**Job Function:**
Medical Affairs Group
**Job Sub** **Function:**
Medical Writing
**Job Category:**
People Leader
**All Job Posting Locations:**
High Wycombe, Buckinghamshire, United Kingdom
**Job Description:**
**Senior Manager/Associate Director, Regulatory Medical Writing X-TA**
At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time.
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at
We are searching for the best talent for a **Senior Manager** **/Associate Director** , **Regulatory Medical Writing** within our Integrated Data Analytics & Reporting (IDAR) business. This role will support one or more of our therapeutic areas within the X-TA (Cross Therapeutic Area) Regulatory Medical Writing area.
**The position can be** **located** **at any of our following offices: High Wycombe (UK), Beerse (Belgium), Leiden (Netherlands),** **Allschwil** **(Switzerland) or Spring House/Raritan/Titusville (East Coast US).**
Hybrid (3 days per week onsite) is strongly preferred. Remote work options may be considered on a case-by-case basis and if approved by the company.
_Are you ready to join our team? Then please read further!_
**You will** **be responsible for** **:**
Leading compound/submission/indication/disease area writing teams independently.
May have additional major responsibility with supervision.
Cross-functional, cross-TA, or cross-J&J initiative/collaboration.
Larger organizational responsibility (eg, manage a subset of TA).
Preparing and finalizing all types of clinical documents, taking a proactive or lead role in terms of content and scientific strategy. Working with a high level of independence and taking a lead role on with respect to timing, scheduling, and tracking.
Leading program-level/submission writing teams independently.
Directly leading or setting objectives for others on team projects and tasks.
Guiding or training crossu2010functional team members on processes, best practices; coach or mentor more junior writers.
Proactively identifying, contributing to and championing Medical Writing process improvements, internal standards, regulatory, and publishing guidelines, internal systems, tools, and processes.
Leading crossu2010functional/crossu2010TA, crossu2010J&J process improvement initiatives, or other large process working groups.
Developing, maintaining and disseminating knowledge of industry, company, and regulatory guidelines to internal and external audiences.
If a lead writer for a program:
Primary point of contact and champion for Medical Writing activities for the clinical team.
Responsible for planning and leading the writing group for assigned program.
Able to function as a lead writer on any compound independently.
Leading discussions in Medical Writing and crossu2010functional meetings as appropriate.
Interacting with senior crossu2010functional colleagues and external partners to strengthen coordination between departments.
Able to oversee the work of external contractors.
As a people manager:
Manage direct reports in Medical Writing.
Set objectives for individual team members. Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
Ensures direct reportu2019s adherence to established policies, procedural documents, and templates
Able to make decision on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, lead in goal setting and performance discussions.
**Qualifications /Requirements:**
University/college degree in a scientific discipline is required. Masters or PhD preferred.
At least 10 years of relevant pharmaceutical/scientific experience; at least 8 years of relevant Medical Writing experience is required!
At least 2 years of people management experience.
Multiple therapeutic area experience preferred.
Strong attention to detail.
Strong oral and written communication skills. Fluent written and spoken English.
Expert project management skills, expert project/process improvement leadership.
Expert leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management). Strong people management skills.
Ability to delegate responsibility to junior writers.
Demonstrated ability to collaborate and develop effective partnerships with key business partners and customers.
Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
United Kingdom - Requisition Number: R-
Belgium, Netherlands - Requisition Number: R-
Switzerland - Requisition Number: R-
United States - Requisition Number: R-
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
**For United States applicants:**
The anticipated base pay range for this position is $137,000 to $235,750 (USD).
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporationu2019s performance over a calendar/ performance year. Bonuses are awarded at the Companyu2019s discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Companyu2019s consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
- Vacation - up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on company benefits, please go to:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
#LI-Hybrid
#LI-Remote
This advertiser has chosen not to accept applicants from your region.
4
Senior Manager/Associate Director,Regulatory Medical Writing X-TA
High Wycombe, South East
J&J Family of Companies
Posted 8 days ago
Job Viewed
Job Description
At Johnson & Johnson,u202fwe believe health is everything. Our strength in healthcare innovation empowers us to build au202fworld where complex diseases are prevented, treated, and cured,u202fwhere treatments are smarter and less invasive, andu202fsolutions are personal.u202fThrough our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.u202fLearn more at
**Job Function:**
Medical Affairs Group
**Job Sub** **Function:**
Medical Writing
**Job Category:**
People Leader
**All Job Posting Locations:**
High Wycombe, Buckinghamshire, United Kingdom
**Job Description:**
**Senior Manager/Associate Director, Regulatory Medical Writing X-TA**
At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time.
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at
We are searching for the best talent for a **Senior Manager** **/Associate Director** , **Regulatory Medical Writing** within our Integrated Data Analytics & Reporting (IDAR) business. This role will support one or more of our therapeutic areas within the X-TA (Cross Therapeutic Area) Regulatory Medical Writing area.
**The position can be** **located** **at any of our following offices: High Wycombe (UK), Beerse (Belgium), Leiden (Netherlands),** **Allschwil** **(Switzerland) or Spring House/Raritan/Titusville (East Coast US).**
Hybrid (3 days per week onsite) is strongly preferred. Remote work options may be considered on a case-by-case basis and if approved by the company.
_Are you ready to join our team? Then please read further!_
**You will** **be responsible for** **:**
Leading compound/submission/indication/disease area writing teams independently.
May have additional major responsibility with supervision.
Cross-functional, cross-TA, or cross-J&J initiative/collaboration.
Larger organizational responsibility (eg, manage a subset of TA).
Preparing and finalizing all types of clinical documents, taking a proactive or lead role in terms of content and scientific strategy. Working with a high level of independence and taking a lead role on with respect to timing, scheduling, and tracking.
Leading program-level/submission writing teams independently.
Directly leading or setting objectives for others on team projects and tasks.
Guiding or training crossu2010functional team members on processes, best practices; coach or mentor more junior writers.
Proactively identifying, contributing to and championing Medical Writing process improvements, internal standards, regulatory, and publishing guidelines, internal systems, tools, and processes.
Leading crossu2010functional/crossu2010TA, crossu2010J&J process improvement initiatives, or other large process working groups.
Developing, maintaining and disseminating knowledge of industry, company, and regulatory guidelines to internal and external audiences.
If a lead writer for a program:
Primary point of contact and champion for Medical Writing activities for the clinical team.
Responsible for planning and leading the writing group for assigned program.
Able to function as a lead writer on any compound independently.
Leading discussions in Medical Writing and crossu2010functional meetings as appropriate.
Interacting with senior crossu2010functional colleagues and external partners to strengthen coordination between departments.
Able to oversee the work of external contractors.
As a people manager:
Manage direct reports in Medical Writing.
Set objectives for individual team members. Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
Ensures direct reportu2019s adherence to established policies, procedural documents, and templates
Able to make decision on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, lead in goal setting and performance discussions.
**Qualifications /Requirements:**
University/college degree in a scientific discipline is required. Masters or PhD preferred.
At least 10 years of relevant pharmaceutical/scientific experience; at least 8 years of relevant Medical Writing experience is required!
At least 2 years of people management experience.
Multiple therapeutic area experience preferred.
Strong attention to detail.
Strong oral and written communication skills. Fluent written and spoken English.
Expert project management skills, expert project/process improvement leadership.
Expert leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management). Strong people management skills.
Ability to delegate responsibility to junior writers.
Demonstrated ability to collaborate and develop effective partnerships with key business partners and customers.
Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
United Kingdom - Requisition Number: R-
Belgium, Netherlands - Requisition Number: R-
Switzerland - Requisition Number: R-
United States - Requisition Number: R-
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
**For United States applicants:**
The anticipated base pay range for this position is $137,000 to $235,750 (USD).
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporationu2019s performance over a calendar/ performance year. Bonuses are awarded at the Companyu2019s discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Companyu2019s consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
- Vacation - up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on company benefits, please go to:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
#LI-Hybrid
#LI-Remote
**Job Function:**
Medical Affairs Group
**Job Sub** **Function:**
Medical Writing
**Job Category:**
People Leader
**All Job Posting Locations:**
High Wycombe, Buckinghamshire, United Kingdom
**Job Description:**
**Senior Manager/Associate Director, Regulatory Medical Writing X-TA**
At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time.
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at
We are searching for the best talent for a **Senior Manager** **/Associate Director** , **Regulatory Medical Writing** within our Integrated Data Analytics & Reporting (IDAR) business. This role will support one or more of our therapeutic areas within the X-TA (Cross Therapeutic Area) Regulatory Medical Writing area.
**The position can be** **located** **at any of our following offices: High Wycombe (UK), Beerse (Belgium), Leiden (Netherlands),** **Allschwil** **(Switzerland) or Spring House/Raritan/Titusville (East Coast US).**
Hybrid (3 days per week onsite) is strongly preferred. Remote work options may be considered on a case-by-case basis and if approved by the company.
_Are you ready to join our team? Then please read further!_
**You will** **be responsible for** **:**
Leading compound/submission/indication/disease area writing teams independently.
May have additional major responsibility with supervision.
Cross-functional, cross-TA, or cross-J&J initiative/collaboration.
Larger organizational responsibility (eg, manage a subset of TA).
Preparing and finalizing all types of clinical documents, taking a proactive or lead role in terms of content and scientific strategy. Working with a high level of independence and taking a lead role on with respect to timing, scheduling, and tracking.
Leading program-level/submission writing teams independently.
Directly leading or setting objectives for others on team projects and tasks.
Guiding or training crossu2010functional team members on processes, best practices; coach or mentor more junior writers.
Proactively identifying, contributing to and championing Medical Writing process improvements, internal standards, regulatory, and publishing guidelines, internal systems, tools, and processes.
Leading crossu2010functional/crossu2010TA, crossu2010J&J process improvement initiatives, or other large process working groups.
Developing, maintaining and disseminating knowledge of industry, company, and regulatory guidelines to internal and external audiences.
If a lead writer for a program:
Primary point of contact and champion for Medical Writing activities for the clinical team.
Responsible for planning and leading the writing group for assigned program.
Able to function as a lead writer on any compound independently.
Leading discussions in Medical Writing and crossu2010functional meetings as appropriate.
Interacting with senior crossu2010functional colleagues and external partners to strengthen coordination between departments.
Able to oversee the work of external contractors.
As a people manager:
Manage direct reports in Medical Writing.
Set objectives for individual team members. Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
Ensures direct reportu2019s adherence to established policies, procedural documents, and templates
Able to make decision on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, lead in goal setting and performance discussions.
**Qualifications /Requirements:**
University/college degree in a scientific discipline is required. Masters or PhD preferred.
At least 10 years of relevant pharmaceutical/scientific experience; at least 8 years of relevant Medical Writing experience is required!
At least 2 years of people management experience.
Multiple therapeutic area experience preferred.
Strong attention to detail.
Strong oral and written communication skills. Fluent written and spoken English.
Expert project management skills, expert project/process improvement leadership.
Expert leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management). Strong people management skills.
Ability to delegate responsibility to junior writers.
Demonstrated ability to collaborate and develop effective partnerships with key business partners and customers.
Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
United Kingdom - Requisition Number: R-
Belgium, Netherlands - Requisition Number: R-
Switzerland - Requisition Number: R-
United States - Requisition Number: R-
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
**For United States applicants:**
The anticipated base pay range for this position is $137,000 to $235,750 (USD).
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporationu2019s performance over a calendar/ performance year. Bonuses are awarded at the Companyu2019s discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Companyu2019s consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
- Vacation - up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on company benefits, please go to:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
#LI-Hybrid
#LI-Remote
This advertiser has chosen not to accept applicants from your region.
5
Senior Manager/Associate Director, Regulatory Medical Writing X-TA
High Wycombe, South East
J&J Family of Companies
Posted 13 days ago
Job Viewed
Job Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
Medical Affairs Group
**Job Sub** **Function:**
Medical Writing
**Job Category:**
People Leader
**All Job Posting Locations:**
High Wycombe, Buckinghamshire, United Kingdom
**Job Description:**
**Senior Manager/Associate Director, Regulatory Medical Writing X-TA**
At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time.
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at are searching for the best talent for a **Senior Manager** **/Associate Director** , **Regulatory Medical Writing** within our Integrated Data Analytics & Reporting (IDAR) business. This role will support one or more of our therapeutic areas within the X-TA (Cross Therapeutic Area) Regulatory Medical Writing area.
**The position can be** **located** **at any of our following offices: High Wycombe (UK), Beerse (Belgium), Leiden (Netherlands),** **Allschwil** **(Switzerland) or Spring House/Raritan/Titusville (East Coast US).**
Hybrid (3 days per week onsite) is strongly preferred. Remote work options may be considered on a case-by-case basis and if approved by the company.
_Are you ready to join our team? Then please read further!_
**You will** **be responsible for** **:**
+ Leading compound/submission/indication/disease area writing teams independently.
+ May have additional major responsibility with supervision.
+ Cross-functional, cross-TA, or cross-J&J initiative/collaboration.
+ Larger organizational responsibility (eg, manage a subset of TA).
+ Preparing and finalizing all types of clinical documents, taking a proactive or lead role in terms of content and scientific strategy. Working with a high level of independence and taking a lead role on with respect to timing, scheduling, and tracking.
+ Leading program-level/submission writing teams independently.
+ Directly leading or setting objectives for others on team projects and tasks.
+ Guiding or training cross‐functional team members on processes, best practices; coach or mentor more junior writers.
+ Proactively identifying, contributing to and championing Medical Writing process improvements, internal standards, regulatory, and publishing guidelines, internal systems, tools, and processes.
+ Leading cross‐functional/cross‐TA, cross‐J&J process improvement initiatives, or other large process working groups.
+ Developing, maintaining and disseminating knowledge of industry, company, and regulatory guidelines to internal and external audiences.
+ If a lead writer for a program:
+ Primary point of contact and champion for Medical Writing activities for the clinical team.
+ Responsible for planning and leading the writing group for assigned program.
+ Able to function as a lead writer on any compound independently.
+ Leading discussions in Medical Writing and cross‐functional meetings as appropriate.
+ Interacting with senior cross‐functional colleagues and external partners to strengthen coordination between departments.
+ Able to oversee the work of external contractors.
+ As a people manager:
+ Manage direct reports in Medical Writing.
+ Set objectives for individual team members. Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
+ Ensures direct report's adherence to established policies, procedural documents, and templates
+ Able to make decision on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, lead in goal setting and performance discussions.
**Qualifications /Requirements:**
+ University/college degree in a scientific discipline is required. Masters or PhD preferred.
+ At least 10 years of relevant pharmaceutical/scientific experience; at least 8 years of relevant Medical Writing experience is required!
+ At least 2 years of people management experience.
+ Multiple therapeutic area experience preferred.
+ Strong attention to detail.
+ Strong oral and written communication skills. Fluent written and spoken English.
+ Expert project management skills, expert project/process improvement leadership.
+ Expert leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management). Strong people management skills.
+ Ability to delegate responsibility to junior writers.
+ Demonstrated ability to collaborate and develop effective partnerships with key business partners and customers.
+ Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
+ United Kingdom - Requisition Number: R-
+ Belgium, Netherlands - Requisition Number: R-
+ Switzerland - Requisition Number: R-
+ United States - Requisition Number: R-
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
**For United States applicants:**
The anticipated base pay range for this position is $137,000 to $235,750 (USD).
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
- Vacation - up to 120 hours per calendar year
+ Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on company benefits, please go to: compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
#LI-Hybrid
#LI-Remote
Medical Affairs Group
**Job Sub** **Function:**
Medical Writing
**Job Category:**
People Leader
**All Job Posting Locations:**
High Wycombe, Buckinghamshire, United Kingdom
**Job Description:**
**Senior Manager/Associate Director, Regulatory Medical Writing X-TA**
At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time.
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at are searching for the best talent for a **Senior Manager** **/Associate Director** , **Regulatory Medical Writing** within our Integrated Data Analytics & Reporting (IDAR) business. This role will support one or more of our therapeutic areas within the X-TA (Cross Therapeutic Area) Regulatory Medical Writing area.
**The position can be** **located** **at any of our following offices: High Wycombe (UK), Beerse (Belgium), Leiden (Netherlands),** **Allschwil** **(Switzerland) or Spring House/Raritan/Titusville (East Coast US).**
Hybrid (3 days per week onsite) is strongly preferred. Remote work options may be considered on a case-by-case basis and if approved by the company.
_Are you ready to join our team? Then please read further!_
**You will** **be responsible for** **:**
+ Leading compound/submission/indication/disease area writing teams independently.
+ May have additional major responsibility with supervision.
+ Cross-functional, cross-TA, or cross-J&J initiative/collaboration.
+ Larger organizational responsibility (eg, manage a subset of TA).
+ Preparing and finalizing all types of clinical documents, taking a proactive or lead role in terms of content and scientific strategy. Working with a high level of independence and taking a lead role on with respect to timing, scheduling, and tracking.
+ Leading program-level/submission writing teams independently.
+ Directly leading or setting objectives for others on team projects and tasks.
+ Guiding or training cross‐functional team members on processes, best practices; coach or mentor more junior writers.
+ Proactively identifying, contributing to and championing Medical Writing process improvements, internal standards, regulatory, and publishing guidelines, internal systems, tools, and processes.
+ Leading cross‐functional/cross‐TA, cross‐J&J process improvement initiatives, or other large process working groups.
+ Developing, maintaining and disseminating knowledge of industry, company, and regulatory guidelines to internal and external audiences.
+ If a lead writer for a program:
+ Primary point of contact and champion for Medical Writing activities for the clinical team.
+ Responsible for planning and leading the writing group for assigned program.
+ Able to function as a lead writer on any compound independently.
+ Leading discussions in Medical Writing and cross‐functional meetings as appropriate.
+ Interacting with senior cross‐functional colleagues and external partners to strengthen coordination between departments.
+ Able to oversee the work of external contractors.
+ As a people manager:
+ Manage direct reports in Medical Writing.
+ Set objectives for individual team members. Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
+ Ensures direct report's adherence to established policies, procedural documents, and templates
+ Able to make decision on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, lead in goal setting and performance discussions.
**Qualifications /Requirements:**
+ University/college degree in a scientific discipline is required. Masters or PhD preferred.
+ At least 10 years of relevant pharmaceutical/scientific experience; at least 8 years of relevant Medical Writing experience is required!
+ At least 2 years of people management experience.
+ Multiple therapeutic area experience preferred.
+ Strong attention to detail.
+ Strong oral and written communication skills. Fluent written and spoken English.
+ Expert project management skills, expert project/process improvement leadership.
+ Expert leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management). Strong people management skills.
+ Ability to delegate responsibility to junior writers.
+ Demonstrated ability to collaborate and develop effective partnerships with key business partners and customers.
+ Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
+ United Kingdom - Requisition Number: R-
+ Belgium, Netherlands - Requisition Number: R-
+ Switzerland - Requisition Number: R-
+ United States - Requisition Number: R-
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
**For United States applicants:**
The anticipated base pay range for this position is $137,000 to $235,750 (USD).
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
- Vacation - up to 120 hours per calendar year
+ Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on company benefits, please go to: compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
#LI-Hybrid
#LI-Remote
This advertiser has chosen not to accept applicants from your region.
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About the latest Medical writing Jobs in United Kingdom !
6
Medical Writer
Holborn, London
£37500 - £45000 Annually
Zero Surplus
Posted 14 days ago
Job Viewed
Job Description
We're delighted to be working with one of the UK's leading medical communications agencies, seeking a Medical Writer to join their dedicated and expanding team.
Your role will be to create and develop high quality and accurate scientific content that meets their clients' goals and requirements.
You will be lead writer on assigned projects, work with a team of junior writers and have previous experience in working with medical communications/and or relevant scientific or medical writing fields.
It is essential you have a degree in a scientific field - ideally biology, medicine, genetics or chemistry.
Responsibilities include:
- Researching and writing a variety of scientific, educational and commercial materials across a range of therapy areas for different target audiences
- Editing and checking the factual accuracy of materials
- Ensuring all outputs align with the client's brief and are delivered on time and on budget
- Developing good client relationships to ensure the retention and growth of business
- Providing regular status updates for projects
- You will have a relevant scientific or medical degree and have had experience in understanding, deciphering and writing medical copy, as well as understanding the pharmaceuticals industry.
This role will be based 2/3 times a week from their London offices (WC2, EC4).
This is an exciting opportunity, with real career growth opportunities as evidenced by existing staff members.
Our client takes special pride in being a warm and embracing employer - benefits of joining their team include:
- 25 days annual leave - plus bank holidays and company holidays
- Health cash plan
- Health and well-being programmes
- Annual flu jab
- Private pension scheme
- Competitive salary
- Professional learning and development
If any of this sounds interesting and you would be open to a conversation to find out more, please send us a copy of your CV and we'll be in touch to discuss the role in more detail.
Zero Surplus is East Anglia's premier recruitment agency, based just outside Cambridge our recruiters source staff for small and international businesses across Hertfordshire, Northants, Milton Keynes, Cambridgeshire, and the East of England.
For registration purposes, please let us know where you are currently based or which locations you are considering as well as your required salary and notice period.
Please upload a Microsoft Word version of your CV where possible, excluding text boxes or images. Any data we collect from you will be stored and processed in accordance with Zero Surplus' Privacy Policy.
This advertiser has chosen not to accept applicants from your region.
7
Medical Writer
Holborn, London
Zero Surplus
Posted 2 days ago
Job Viewed
Job Description
We're delighted to be working with one of the UK's leading medical communications agencies, seeking a Medical Writer to join their dedicated and expanding team.
Your role will be to create and develop high quality and accurate scientific content that meets their clients' goals and requirements.
You will be lead writer on assigned projects, work with a team of junior writers and have previous experience in working with medical communications/and or relevant scientific or medical writing fields.
It is essential you have a degree in a scientific field - ideally biology, medicine, genetics or chemistry.
Responsibilities include:
- Researching and writing a variety of scientific, educational and commercial materials across a range of therapy areas for different target audiences
- Editing and checking the factual accuracy of materials
- Ensuring all outputs align with the client's brief and are delivered on time and on budget
- Developing good client relationships to ensure the retention and growth of business
- Providing regular status updates for projects
- You will have a relevant scientific or medical degree and have had experience in understanding, deciphering and writing medical copy, as well as understanding the pharmaceuticals industry.
This role will be based 2/3 times a week from their London offices (WC2, EC4).
This is an exciting opportunity, with real career growth opportunities as evidenced by existing staff members.
Our client takes special pride in being a warm and embracing employer - benefits of joining their team include:
- 25 days annual leave - plus bank holidays and company holidays
- Health cash plan
- Health and well-being programmes
- Annual flu jab
- Private pension scheme
- Competitive salary
- Professional learning and development
If any of this sounds interesting and you would be open to a conversation to find out more, please send us a copy of your CV and we'll be in touch to discuss the role in more detail.
Zero Surplus is East Anglia's premier recruitment agency, based just outside Cambridge our recruiters source staff for small and international businesses across Hertfordshire, Northants, Milton Keynes, Cambridgeshire, and the East of England.
For registration purposes, please let us know where you are currently based or which locations you are considering as well as your required salary and notice period.
Please upload a Microsoft Word version of your CV where possible, excluding text boxes or images. Any data we collect from you will be stored and processed in accordance with Zero Surplus' Privacy Policy.
This advertiser has chosen not to accept applicants from your region.
8
Principal Medical Writer
ICON Clinical Research
Posted 5 days ago
Job Viewed
Job Description
Senior/Principal Medical Writer - Europe/UK or South Africa based
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking Senior or Principal Medical Writer to join our diverse and dynamic team. At this role you will be responsible for leading the development of high-quality regulatory and clinical documents that effectively communicate scientific and medical information. Your expertise in medical writing will be crucial in supporting our clients' submissions to regulatory authorities and ensuring compliance with industry standards.
We hire at Medical Writer 2, Senior Medical Writer or Principal Medical Writer level
**What You Will Be Doing:**
Guides medical writing document preparation, including coordination of assignments to writers, review, and substantive editing of documents. As necessary, may assume primary responsibility for preparation of key regulatory response documents and documents supporting major regulatory submission. Formulates writing approach, develops timelines, and assesses resource requirements for key documents and regulatory submissions within designated therapeutic or functional area. Participates on relevant project teams and task forces, and provides functional and cross-functional guidance on a wide range of issues related to document preparation, including international regulatory guidance and requirements for content and format, work requirements (style, electronic integrity, and process), and project- or therapeutic area-specific guidance related to content and organization of specific documents.
+ Leads the writing strategy providing expertise including organization, content, timelines, and resource requirements.
+ Provides more complex advanced input for study designs, analysis plans, sections of INDs and marketing applications
+ Provides review and substantive editing of contributions, and ensures resolution of issues.
+ Within designated therapeutic or compound function, manages deliverables and preparation of documents for submission to regulatory agencies, ensuring consistency of content within therapeutic areas and adherence to regulatory requirements and Sponsor requirements and processes across development programs.
+ Represents Medical Writing on cross-functional teams and task forces (related to projects, process, and standards).
+ Acts as a key Medical Point of contact for clinical regulatory strategy
+ As required, serves as lead writer for important regulatory response documents and key components of regulatory submissions.
+ Provides leadership on functional teams that address requirements or issues related to document preparation and production.
+ The Principal Medical Writer is seen as an expert in medical writing and performs work independently with minimal supervision.
**Your Profile:**
+ Bachelor's degree in science, health profession required
+ At least 5 years of experience writing for pharma or biotechnology preferred . 3+ years of electronic documents and submissions required.
+ Experience as lead writer for **key documents included in major international regulatory submissions required like Clinical study reports, IBs, Protocols**
+ Experience managing writing activities for a major international regulatory submission preferred.
**Knowledge and Skills:**
+ Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products.
+ Understanding of international regulations, ICH guidelines, and applicable international regulatory processes related to document preparation and production (including CTDs).
+ Well-developed oral and written communication skills; ability to clearly present technical information within and across functional areas.
+ Demonstrated problem-solving and interpersonal skills that facilitate effective interactions within functional and cross-functional teams and with external providers
**#LI-NR1**
**#LI-Remote**
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site ( to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here ( in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here ( to apply
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking Senior or Principal Medical Writer to join our diverse and dynamic team. At this role you will be responsible for leading the development of high-quality regulatory and clinical documents that effectively communicate scientific and medical information. Your expertise in medical writing will be crucial in supporting our clients' submissions to regulatory authorities and ensuring compliance with industry standards.
We hire at Medical Writer 2, Senior Medical Writer or Principal Medical Writer level
**What You Will Be Doing:**
Guides medical writing document preparation, including coordination of assignments to writers, review, and substantive editing of documents. As necessary, may assume primary responsibility for preparation of key regulatory response documents and documents supporting major regulatory submission. Formulates writing approach, develops timelines, and assesses resource requirements for key documents and regulatory submissions within designated therapeutic or functional area. Participates on relevant project teams and task forces, and provides functional and cross-functional guidance on a wide range of issues related to document preparation, including international regulatory guidance and requirements for content and format, work requirements (style, electronic integrity, and process), and project- or therapeutic area-specific guidance related to content and organization of specific documents.
+ Leads the writing strategy providing expertise including organization, content, timelines, and resource requirements.
+ Provides more complex advanced input for study designs, analysis plans, sections of INDs and marketing applications
+ Provides review and substantive editing of contributions, and ensures resolution of issues.
+ Within designated therapeutic or compound function, manages deliverables and preparation of documents for submission to regulatory agencies, ensuring consistency of content within therapeutic areas and adherence to regulatory requirements and Sponsor requirements and processes across development programs.
+ Represents Medical Writing on cross-functional teams and task forces (related to projects, process, and standards).
+ Acts as a key Medical Point of contact for clinical regulatory strategy
+ As required, serves as lead writer for important regulatory response documents and key components of regulatory submissions.
+ Provides leadership on functional teams that address requirements or issues related to document preparation and production.
+ The Principal Medical Writer is seen as an expert in medical writing and performs work independently with minimal supervision.
**Your Profile:**
+ Bachelor's degree in science, health profession required
+ At least 5 years of experience writing for pharma or biotechnology preferred . 3+ years of electronic documents and submissions required.
+ Experience as lead writer for **key documents included in major international regulatory submissions required like Clinical study reports, IBs, Protocols**
+ Experience managing writing activities for a major international regulatory submission preferred.
**Knowledge and Skills:**
+ Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products.
+ Understanding of international regulations, ICH guidelines, and applicable international regulatory processes related to document preparation and production (including CTDs).
+ Well-developed oral and written communication skills; ability to clearly present technical information within and across functional areas.
+ Demonstrated problem-solving and interpersonal skills that facilitate effective interactions within functional and cross-functional teams and with external providers
**#LI-NR1**
**#LI-Remote**
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site ( to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here ( in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here ( to apply
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