68 Medical Writing jobs in the United Kingdom
Medical Writing Manager (Regulatory Writing)
Reading, South East
IQVIA
Posted 17 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
Medical Writing Vacancies (Multiple Levels)
CM Consulting
Posted 2 days ago
Job Viewed
Job Description
We have writing vacancies across multiple levels;
- Medical Writer
- Senior Medical Writer
- Principal Medical Writer
- Copywriter/Senior Copywriter
Each role is with a fantastic healthcare communications agency, with locations across the UK (offering both remote and hybrid work)
PLEASE NOTE: These roles are available for UK BASED CANDIDATES ONLY. If you are outside of the UK please DO NOT APPLY.
Perks and Benefits:
- HYBRID AND REMOTE ROLES
- COLLABORATIVE, INNOVATIVE TEAMS
- EXCEPTIONAL BENEFITS ABOVE INDUSTRY STANDARD
Candidates must have:
- Experience in a medical writing role as part of a healthcare comms agency
- Minimum BSc in life sciences (PhD advantageous)
- Experience working across a variety of materials, including publications (experience in Neurology/Oncology/Rare diseases/HIV advantageous)
This advertiser has chosen not to accept applicants from your region.
1
Manager,X-TA Regulatory Medical Writing
High Wycombe, South East
J&J Family of Companies
Posted 24 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:**
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 **Manager, Regulatory Medical Writing** to support one or more of our therapeutic areas in within the X-TA Regulatory Medical Writing unit, Integrated Data Analytics & Reporting (IDAR) business.
The position may be in the UK (High Wycombe), Belgium (Beerse), Netherlands (Leiden) or the United States (Raritan, Springhouse or Titusville). **While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.**
The position is Hybrid (3 days onsite weekly). 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:**
Preparing and finalizing all types of clinical documents independently within and across therapeutic areas (TAs).
Leading in a team environment. Working with a high level of independence and taking a lead role on assigned projects with respect to content and scientific strategy, timing, scheduling, and tracking. May consult with more senior colleagues on complex situations.
Lead and actively participate in setting functional tactics/strategy as needed.
Oversee the work of external contractors
Leading or setting objectives for others on team projects and tasks, eg, leading process working groups.
Guiding or training cross-functional team members on processes and best practices.
Potentially leading project-level/submission/indication writing teams.
If a lead writer for a program/compound (or submissions, indications, or disease areas): act as the 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.
Actively participating in medical writing and cross-functional meetings.
Proactively provide recommendations for departmental process improvements.
Maintaining knowledge of industry, company, and regulatory guidelines.
Coaching or mentoring more junior staff on document planning, processes, content, and provide peer review as needed, overseeing the work of other medical writers, external contractors, and document specialists supporting a project.
Interacting with senior cross-functional colleagues to strengthen coordination between departments.
Representing Medical Writing department in industry standards working groups if and as needed.
Complete all time reporting, training, and metrics database updates as required in relevant company systems.
If a people manager:
Manage a team of internal medical writers (direct reports).
Setting objectives for individual team members, conducting career and talent development discussions for staff, lead in goal setting, and performance discussions.
Regularly meeting with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
Ensures direct reportu2019s adherence to established policies, procedural documents, and templates.
Accountable for the quality of deliverables and for compliance of direct reports.
Participate in resource management and hiring decisions.
**Education and Experience Requirements:**
University/college degree required. Masters or PhD preferred.
At least 8 years of relevant pharmaceutical/scientific experience; at least 6 years of relevant medical writing experience is required!
If a people manager, preferably up to 2 years of people management experience.
**Other Requirements:**
Experience of multiple therapeutic areas preferred.
Attention to detail.
Excellent oral and written communication skills are pivotal to engage in cross-functional discussions. English fluency required.
Expert project/time management skills.
Strong project/process leadership skills.
Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content.
Able to resolve complex problems independently.
Demonstrate learning agility.
Able to build and maintain solid and positive relationships with crossu2010functional team members.
Solid knowledge and application of regulatory guidance documents such as ICH requirements.
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-
Netherlands, Belgium- Requisition Number: R-R-
United States - Requisition Number: R-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 $115,000 to $197,000 (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:**
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 **Manager, Regulatory Medical Writing** to support one or more of our therapeutic areas in within the X-TA Regulatory Medical Writing unit, Integrated Data Analytics & Reporting (IDAR) business.
The position may be in the UK (High Wycombe), Belgium (Beerse), Netherlands (Leiden) or the United States (Raritan, Springhouse or Titusville). **While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.**
The position is Hybrid (3 days onsite weekly). 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:**
Preparing and finalizing all types of clinical documents independently within and across therapeutic areas (TAs).
Leading in a team environment. Working with a high level of independence and taking a lead role on assigned projects with respect to content and scientific strategy, timing, scheduling, and tracking. May consult with more senior colleagues on complex situations.
Lead and actively participate in setting functional tactics/strategy as needed.
Oversee the work of external contractors
Leading or setting objectives for others on team projects and tasks, eg, leading process working groups.
Guiding or training cross-functional team members on processes and best practices.
Potentially leading project-level/submission/indication writing teams.
If a lead writer for a program/compound (or submissions, indications, or disease areas): act as the 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.
Actively participating in medical writing and cross-functional meetings.
Proactively provide recommendations for departmental process improvements.
Maintaining knowledge of industry, company, and regulatory guidelines.
Coaching or mentoring more junior staff on document planning, processes, content, and provide peer review as needed, overseeing the work of other medical writers, external contractors, and document specialists supporting a project.
Interacting with senior cross-functional colleagues to strengthen coordination between departments.
Representing Medical Writing department in industry standards working groups if and as needed.
Complete all time reporting, training, and metrics database updates as required in relevant company systems.
If a people manager:
Manage a team of internal medical writers (direct reports).
Setting objectives for individual team members, conducting career and talent development discussions for staff, lead in goal setting, and performance discussions.
Regularly meeting with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
Ensures direct reportu2019s adherence to established policies, procedural documents, and templates.
Accountable for the quality of deliverables and for compliance of direct reports.
Participate in resource management and hiring decisions.
**Education and Experience Requirements:**
University/college degree required. Masters or PhD preferred.
At least 8 years of relevant pharmaceutical/scientific experience; at least 6 years of relevant medical writing experience is required!
If a people manager, preferably up to 2 years of people management experience.
**Other Requirements:**
Experience of multiple therapeutic areas preferred.
Attention to detail.
Excellent oral and written communication skills are pivotal to engage in cross-functional discussions. English fluency required.
Expert project/time management skills.
Strong project/process leadership skills.
Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content.
Able to resolve complex problems independently.
Demonstrate learning agility.
Able to build and maintain solid and positive relationships with crossu2010functional team members.
Solid knowledge and application of regulatory guidance documents such as ICH requirements.
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-
Netherlands, Belgium- Requisition Number: R-R-
United States - Requisition Number: R-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 $115,000 to $197,000 (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
Associate Director,X-TA Regulatory Medical Writing
High Wycombe, South East
J&J Family of Companies
Posted 24 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:**
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 an **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 Regulatory Medical Writing area.
This position is open globally and may be in Europe (eg, United Kingdom, Ireland, Belgium, Netherlands, Germany, France, Spain, Italy), in addition to North America (eg, Spring House, PA, Raritan, NJ, or Titusville, NJ). While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.
This can be a hybrid (3 days in office and 2 remote) OR Remote role available in all countries listed above. 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!
If a people manager, 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-
Europe (BE/FR/DE/IRE/IT/NL/ES)- Requisition Number: R-
United States (East Coast)- 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 an **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 Regulatory Medical Writing area.
This position is open globally and may be in Europe (eg, United Kingdom, Ireland, Belgium, Netherlands, Germany, France, Spain, Italy), in addition to North America (eg, Spring House, PA, Raritan, NJ, or Titusville, NJ). While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.
This can be a hybrid (3 days in office and 2 remote) OR Remote role available in all countries listed above. 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!
If a people manager, 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-
Europe (BE/FR/DE/IRE/IT/NL/ES)- Requisition Number: R-
United States (East Coast)- 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.
3
Analyst II, Regulatory Medical Writing X-TA
High Wycombe, South East
J&J Family of Companies
Posted 5 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:**
Professional
**All Job Posting Locations:**
High Wycombe, Buckinghamshire, United Kingdom
**Job Description:**
**Analyst II, Regulatory Medical Writing X-TA**
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 **Analyst II, Regulatory Medical Writing, X-TA** to support across key therapeutic areas (X-TA) within our Integrated Data Analytics & Reporting (IDAR) business. The position may be located **High Wycombe, UK; Leiden, Netherlands or Beerse, Belgium.** The position is hybrid (3 days onsite weekly). Remote work options including from other EU countries may be considered on a case-by-case basis and if approved by the company.
As Analyst II, Regulatory Medical Writing X-TA, you will support across one or more of our therapeutic areas (Oncology, Immunology, Neuroscience, Cardiopulmonary, Specialty Ophthalmology) within our Regulatory Medical Writing team, to author diverse regulatory medical writing documents.
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):
_Are you ready to join our team? Then please read further!_
**Purpose:**
+ Develop within the medical writing role within the pharmaceutical industry.
+ Work in a team environment and matrix.
+ Gain knowledge and apply internal standards, regulatory, and publishing guidelines.
+ Learn and use internal systems, tools, and processes.
+ Write and coordinate basic documents and help to prepare more complex documents.
+ Perform routine tasks per established procedures.
**You will be responsible for:**
+ Write and coordinate clinical documents such as protocols, clinical study reports, tables of studies, narratives, and investigator's brochures with oversight.
+ Perform document QC, literature searches, and other tasks.
+ Work in a matrix environment and gain an understanding of the medical writing responsibilities on project teams.
+ Partner with experienced colleagues on document planning, timelines, and content development according to internal processes.
+ Participate in or lead cross-functional document planning and review meetings independently or with oversight.
+ May participate in initiatives to improve medical writing processes and standards.
+ Acquire, maintain, and apply knowledge of industry, company, and regulatory guidelines.
+ Regularly meet with manager and mentors and attend departmental meetings.
**Qualifications / Requirements:**
+ A university/college degree in a scientific discipline is the minimum requirement, with an advanced degree (eg, Master's degree, PhD, MD) preferred.
+ At least 2 years of relevant pharmaceutical/scientific experience is required.
+ Strong oral and written communication skills in English.
+ Ability to understand, interpret, and summarize scientific or medical data.
+ Ability to function in a team environment and to build solid and positive relationships with cross‐functional team members.
+ Demonstrated problem-solving skills.
+ Strong attention to detail.
+ Strong time management and project/process management skills.
+ Demonstrated learning agility.
+ Sound knowledge of Microsoft Office programs (eg, Microsoft Word, Excel, PowerPoint, Outlook).
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-
+ Netherlands, Belgium- Requisition Number: R-
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
**Benefits**
We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our organisation. For additional general information on company benefits, please go to: qualified applicants will be considered for employment without regard to any other characteristic protected by law. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform important job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodations.
#LI-Hybrid
#LI-Remote
Medical Affairs Group
**Job Sub** **Function:**
Medical Writing
**Job Category:**
Professional
**All Job Posting Locations:**
High Wycombe, Buckinghamshire, United Kingdom
**Job Description:**
**Analyst II, Regulatory Medical Writing X-TA**
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 **Analyst II, Regulatory Medical Writing, X-TA** to support across key therapeutic areas (X-TA) within our Integrated Data Analytics & Reporting (IDAR) business. The position may be located **High Wycombe, UK; Leiden, Netherlands or Beerse, Belgium.** The position is hybrid (3 days onsite weekly). Remote work options including from other EU countries may be considered on a case-by-case basis and if approved by the company.
As Analyst II, Regulatory Medical Writing X-TA, you will support across one or more of our therapeutic areas (Oncology, Immunology, Neuroscience, Cardiopulmonary, Specialty Ophthalmology) within our Regulatory Medical Writing team, to author diverse regulatory medical writing documents.
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):
_Are you ready to join our team? Then please read further!_
**Purpose:**
+ Develop within the medical writing role within the pharmaceutical industry.
+ Work in a team environment and matrix.
+ Gain knowledge and apply internal standards, regulatory, and publishing guidelines.
+ Learn and use internal systems, tools, and processes.
+ Write and coordinate basic documents and help to prepare more complex documents.
+ Perform routine tasks per established procedures.
**You will be responsible for:**
+ Write and coordinate clinical documents such as protocols, clinical study reports, tables of studies, narratives, and investigator's brochures with oversight.
+ Perform document QC, literature searches, and other tasks.
+ Work in a matrix environment and gain an understanding of the medical writing responsibilities on project teams.
+ Partner with experienced colleagues on document planning, timelines, and content development according to internal processes.
+ Participate in or lead cross-functional document planning and review meetings independently or with oversight.
+ May participate in initiatives to improve medical writing processes and standards.
+ Acquire, maintain, and apply knowledge of industry, company, and regulatory guidelines.
+ Regularly meet with manager and mentors and attend departmental meetings.
**Qualifications / Requirements:**
+ A university/college degree in a scientific discipline is the minimum requirement, with an advanced degree (eg, Master's degree, PhD, MD) preferred.
+ At least 2 years of relevant pharmaceutical/scientific experience is required.
+ Strong oral and written communication skills in English.
+ Ability to understand, interpret, and summarize scientific or medical data.
+ Ability to function in a team environment and to build solid and positive relationships with cross‐functional team members.
+ Demonstrated problem-solving skills.
+ Strong attention to detail.
+ Strong time management and project/process management skills.
+ Demonstrated learning agility.
+ Sound knowledge of Microsoft Office programs (eg, Microsoft Word, Excel, PowerPoint, Outlook).
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-
+ Netherlands, Belgium- Requisition Number: R-
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
**Benefits**
We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our organisation. For additional general information on company benefits, please go to: qualified applicants will be considered for employment without regard to any other characteristic protected by law. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform important job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodations.
#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 18 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 5 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 & Senior Medical Writer
CLR Health Ltd
Posted 1 day ago
Job Viewed
Job Description
Medical Writer & Senior Medical Writer Opportunities – London
An outstanding Med Comms agency, located in one of London’s most vibrant areas, is looking to welcome talented Medical Writers and Senior Medical Writers to its growing team.
As part of a collaborative and ambitious medical writing team, you’ll have the chance to build deep scientific expertise across a variety of therapeutic areas—including Rare Disease, Oncology, Cardiovascular, and Diabetes. You’ll contribute to a broad range of projects such as multi-component initiatives, medical education materials, symposia, and meetings—with the option to get involved in publications too.
We’re keen to hear from experienced Medical Writers and Senior Medical Writers , as well as Associate Medical Writers who are ready to take the next step. To be successful, you must have recent experience in a UK-based medical communications agency .
This is a varied and rewarding role offering the opportunity to broaden your writing experience while working within a supportive and inspiring team.
What’s on offer:
- Flexible hours and hybrid working arrangements
- A highly competitive salary and benefits package
- Genuine opportunities for career progression
If you’re ready for your next challenge, apply today to find out more.
Please note: You must have current experience in a UK medical communications agency and full rights to work in the UK to be considered.
This advertiser has chosen not to accept applicants from your region.
7
Medical Writer & Senior Medical Writer
London, London
CLR Health Ltd
Posted 1 day ago
Job Viewed
Job Description
Medical Writer & Senior Medical Writer Opportunities – London
An outstanding Med Comms agency, located in one of London’s most vibrant areas, is looking to welcome talented Medical Writers and Senior Medical Writers to its growing team.
As part of a collaborative and ambitious medical writing team, you’ll have the chance to build deep scientific expertise across a variety of therapeutic areas—including Rare Disease, Oncology, Cardiovascular, and Diabetes. You’ll contribute to a broad range of projects such as multi-component initiatives, medical education materials, symposia, and meetings—with the option to get involved in publications too.
We’re keen to hear from experienced Medical Writers and Senior Medical Writers , as well as Associate Medical Writers who are ready to take the next step. To be successful, you must have recent experience in a UK-based medical communications agency .
This is a varied and rewarding role offering the opportunity to broaden your writing experience while working within a supportive and inspiring team.
What’s on offer:
- Flexible hours and hybrid working arrangements
- A highly competitive salary and benefits package
- Genuine opportunities for career progression
If you’re ready for your next challenge, apply today to find out more.
Please note: You must have current experience in a UK medical communications agency and full rights to work in the UK to be considered.
This advertiser has chosen not to accept applicants from your region.
8
Medical Writer
Holborn, London
Zero Surplus
Posted 3 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.
9