109 Regulatory Writing jobs in the United Kingdom

**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

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-020998



Netherlands, Belgium- Requisition Number: R-R-021535



United States - Requisition Number: R-R-021538



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

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:**
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 **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 report's 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 cross‐functional 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-020998
Netherlands, Belgium- Requisition Number: R-R-021535
United States - Requisition Number: R-R-021538
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 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

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-020783



Europe (BE/FR/DE/IRE/IT/NL/ES)- Requisition Number: R-021380



United States (East Coast)- Requisition Number: R-021383



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

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
Medical Affairs Group
**Job Sub** **Function:**
Medical Writing
**Job Category:**
People Leader
**All Job Posting Locations:**
High Wycombe, Buckinghamshire, United Kingdom
**Job Description:**
At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time.
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at are searching for the best talent for 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 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!
+ 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-020783
Europe (BE/FR/DE/IRE/IT/NL/ES)- Requisition Number: R-021380
United States (East Coast)- Requisition Number: R-021383
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

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-027208


Belgium, Netherlands - Requisition Number: R-028681


Switzerland - Requisition Number: R-028682


United States - Requisition Number: R-028683



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

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-027208
+ Belgium, Netherlands - Requisition Number: R-028681
+ Switzerland - Requisition Number: R-028682
+ United States - Requisition Number: R-028683
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

Location: Essex

Salary Package : 46,142 - 52,514 per annum

Benefits for the Regulatory affairs Officer :

• • Permanent full-time role with stability and employment benefits
    
  • Prestigious local authority
  • Work for a special project within

    DEPARTMENT FOR NEIGHBOURHOODS AND ENVIRONMENT

    PUBLIC PROTECTION

  • Local government pension scheme
  • Generous annual leave
  • Flexible working
  • Training and development

NonStop Consulting is currently working with UK government authority to recruit a Regulatory Affairs Officer for one of the local councils in Essex.

Responsibilities of Regulatory Affairs Officer:

To carry out a range of complex Regulatory Services duties including taking lead responsibility for statutory functions involving projects / inspection programmes / major or complex investigations / supervising other staff members / regional coordination work / council's corporate projects (business partnerships etc)

Please apply if:

- you have experience applying national/regional/local policies to regulatory services work
- evidence of CPD (Continuous Professional Development)
- complex housing disrepair issues/ complex investigations

- you have Professional Qualification in a relevant area of Regulatory Services

You can send your CV directly to me at (url removed)

If you believe this opportunity isn't the right fit for you but know someone who would be a great match, we would love to hear from them! We offer a 200 referral bonus through our referral scheme.