106 Regulatory Writing jobs in the United Kingdom

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

Regulatory Affairs Manager / Remote / 24.43 per hour PAYE

We are seeking an experienced Regulatory Affairs Manager to lead and support complex clinical trial application projects across Europe and beyond. This fully remote contractor role offers the opportunity to work on strategic regulatory initiatives, collaborate with global teams, and guide clients through the evolving EU Clinical Trials Regulation (EUCTR) landscape.

About the Role

This is a strategic, client-facing position focused on pre-approval clinical trial applications , particularly under the EUCTR framework. You will oversee regulatory submissions via the CTIS portal , manage cross-functional collaboration, and provide expert guidance on documentation, timelines, and regulatory strategy.

Key Responsibilities

• Lead EUCTR submissions, including preparation of core packages for Part 1 and coordination with local teams for Part 2 .
• Ensure familiarity with redactions and the regulatory distinctions between Part 1 and Part 2.
• Develop and execute regulatory submission strategies , including review of CMC and IMPD data.
• Provide strategic oversight of clinical trial applications, not limited to operational submission tasks.
• Collaborate with country teams on ethics submissions and post-submission maintenance (e.g., notifications, substantial amendments).
• Engage directly with clients to guide documentation requirements, set timelines, and communicate regulatory expectations.
• Review and manage project budgets, ensuring scope alignment and revenue recognition.
• Support global regulatory initiatives and contribute to SOP development and review.
• Mentor junior colleagues and contribute to internal training and development.

What We're Looking For

• Minimum 8 years of relevant regulatory experience in life sciences.
• Proven expertise in EUCTR , CTIS , and clinical trial applications .
• Strong technical writing skills, particularly in compiling IMPD and CMC data.
• Strategic mindset with experience in regulatory planning and client-facing communication.
• Ability to manage multiple projects, with assignments varying based on project size and scope.
• Experience in biotech, cell and gene therapy, or IVD is beneficial but not required.

Bonus Skills

• Experience with regulatory submissions in US, Canada, Latin America, or sub-Saharan Africa .
• Familiarity with regulatory portals such as Swissmedic and ARIS for UK submissions.
• Understanding of pharmacovigilance activities relevant to marketing authorisation transfers.

This is a 6 month Temporary contract with the potential to extend.

__PRESENT__PRESENT

Should you require any support or assistance, please contact your local Gi Group office.

Gi Group Holdings Recruitment Limited are proud founding members of Menopause in business, pledge members for Neurodiversity in business, Disability committed members, Silver status pledge members for the Armed Forces Covenant, and Bronze trail blazers for Racial Equality matters.

Gi Group of companies includes Gi Group Holdings Recruitment Ltd, Gi Recruitment Ltd, Draefern Ltd, Excel Resourcing (Recruitment Consultants) Ltd, Gi Recruitment Ltd, INTOO (UK) Ltd, Marks Sattin (UK) Ltd, TACK TMI UK Ltd, TACK International Ltd, Grafton Professional Staffing Ltd, Encore Personnel Services Ltd, Gi Group Staffing Solutions Ltd and Gi Group Ireland Ltd. Gi Group Staffing Solutions Ltd are acting as an Employment Business in relation to this role.

We are committed to protecting the privacy of all our candidates and clients. If you choose to apply, your information will be processed in accordance with the Gi Group Privacy Statement. To view a copy and to help you understand how we collect, use and process your personal data please visit the Privacy page on our Gi Group website.

Regulatory Affairs Officer
Location: Chester
Salary: £38,000 – £42,000 per annum
Hours: Monday – Friday, Standard Day Shifts
Benefits: Generous Annual Leave, Enhanced Private Health Insurance, Top Tier Pension Contributions 

Are you a detail-driven professional passionate about pharmaceutical compliance? Trek Recruitment is delighted to recruit for our client, a forward-thinking pharmaceutical leader based near Chester. We’re seeking an experienced Regulatory Affairs Officer to join their dynamic team, offering a fantastic opportunity to grow within an award-winning organisation and to take the rains and bring parts of the regulatory affairs process in-house. 

THE ROLE
As a Regulatory Affairs Officer you will be -

• Preparing and managing regulatory documentation for a diverse product portfolio.
• Organising and maintaining compliant regulatory records as per industry standards.
• Tracking and reporting regulatory project progress to stakeholders.
• Keeping abreast of regulatory changes and communicating updates to internal teams.
• Monitoring industry trends to ensure ongoing compliance with pharmaceutical regulations.
• Supporting client communications related to regulatory processes and updates.

Who We’re Looking For Our client seeks a motivated individual with a solid regulatory background , someone to make the job their own and help the department grow.

YOU

To thrive in this role, you will need:

• A Bachelor’s degree in a scientific, healthcare, or related field.
• Proven experience in Regulatory Affairs within the pharmaceutical industry.
• Exceptional organisational skills and meticulous attention to detail.
• Strong written and verbal communication skills.
• Adaptability to evolving regulatory requirements.
• A collaborative spirit, excelling in team-oriented settings.
• Proficiency in standard office software (e.g., Microsoft Word, Excel, Outlook).
• A drive for professional development in regulatory affairs.
• Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP).

Desirable Qualifications

• Experience with regulatory submissions for new products or post-market changes.

Keywords: Regulatory Affairs Officer, Pharmaceutical Jobs, Deeside Careers, Regulatory Compliance, GMP, GCP, Pharmaceutical Industry, Trek Recruitment, Top Workplace 2024, Healthcare Jobs.

What does 'family business' mean to you?

For some, it's code for small, for others it is a collaborative and friendly space.

The truth - it's usually both.

Family, small to midsized pharmaceutical companies look after their staff. You become part of their community, their culture, and the way they do things.

In our experience, staff at family run SMEs experience longer levels of employment than at large global corporations, and are often compensated well over time for their rewards.

Which is why, I am delighted to be representing a leading (family run) pharmaceutical manufacturing organisation based near Watford in the UK.

This amazing company are going through a great transformation that should ensure the company's future for generations to come, and as part of that they are looking for reliable, professional and hard working Regulatory Affairs professionals.

As part of this expansion, our client is looking for someone with 5+ years experience in Pharmaceutical Regulatory Affairs (ideally in a similar style of company, but they are open to people from all different pharmaceutical organisations).

You need to have a hard working attitude, good attention to detail, and you need to be able to work well with your team. Your experience in eCTD manager and document management tools will be valued, and you will need knowledge of global Regulatory requirements and guidelines (MHRA, EMA and ICH).

This is a site based role near Watford (5 days per week) and would suit someone looking for a company they can grow with, and build with, and that will give them huge career tragectory in a culture that is supportive and dynamic.

Interested? Apply Now!