1,749 Medical Writers jobs in the United States

Director of Regulatory Writing

California, California iO Associates

Posted today

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Job Description

Director of Regulatory Writing (Biotech)

Contract Duration:
Up to 12 months

Rate:
Up to $140 per hour (DOE)

iO Associates is partnering with a
clinical-stage biopharmaceutical company
advancing innovative therapies for serious infectious diseases and oncology. The business is driven by a mission to harness the power of the immune system to improve patient outcomes. With a strong pipeline spanning late preclinical to clinical-stage assets, they are now seeking a
Regulatory Writing Director (Contract)
to support key global submissions and clinical documentation activities.

The Opportunity

As the
Regulatory Writing Director
, you'll play a pivotal role in preparing high-quality, compliant documents that support regulatory submissions to global health authorities (FDA, EMA, and others). You'll work cross-functionally with clinical, biostatistics, regulatory affairs, and safety teams to ensure scientific accuracy, clarity, and consistency across all programs.

This role reports into the SVP of Regulatory Affairs and offers the opportunity to contribute to a high-impact development pipeline.

Key Responsibilities

  • Author and edit a range of regulatory documents including clinical protocols, Investigator's Brochures (IBs), Clinical Study Reports (CSRs), briefing documents, IND/NDA/MAA submission modules, and summaries of efficacy and safety.
  • Ensure all documents comply with ICH and other applicable regulatory guidelines (e.g., ICH E3, ICH M4).
  • Translate complex clinical and scientific data into clear, concise, and accurate regulatory language.
  • Collaborate closely with cross-functional leads to ensure alignment and consistency across programs.
  • Plan and manage writing deliverables, timelines, and review cycles for multiple concurrent projects.

About You

  • Bachelor's degree in a scientific or medical discipline (advanced degree preferred).
  • 10+ years of experience in regulatory or medical writing within biotechnology or pharmaceuticals.
  • Strong familiarity with eCTD structure and ICH guidelines.
  • Experience authoring key regulatory documents such as CSRs, IBs, DSURs, protocols, and clinical modules.
  • Proven involvement in marketing applications (INDs, NDAs, BLAs, MAAs, or equivalent).
  • Ability to manage multiple priorities and communicate effectively across disciplines.

Why Join

You'll join a purpose-driven, science-led organization that values collaboration, integrity, and innovation. This is an excellent opportunity to contribute to life-changing programs while working within a flexible and supportive environment.

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Senior Analyst Regulatory Medical Writing, Immunology

19477 Spring House, Pennsylvania J&J Family of Companies

Posted 3 days ago

Job Viewed

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Job Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
Medical Affairs Group
**Job Sub** **Function:**
Medical Writing
**Job Category:**
Professional
**All Job Posting Locations:**
Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America
**Job Description:**
**Senior Analyst Regulatory Medical Writing, Immunology**
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 Analyst Regulatory Medical Writing,** within Integrated Data Analytics & Reporting (IDAR), to join our diverse team of medical writers for immunology indications. **The role can be located High Wycombe, United Kingdom; Beerse, Belgium; Leiden, Netherlands; Neuss, Germany, or Springhouse / Raritan / Titusville, United States.** Hybrid working is expected for applicants living within commutable distance of a J&J office (3 days onsite per week). Remote work options may be considered on a case-by-case basis for those outside tenable commutable area, and if approved by the company.
_Are you ready to join our team? Then please read further!_
**You will be responsible for:**
+ Writing or coordinating clinical and regulatory documents such as, but not limited to, CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents.
+ Leading cross-functional document planning and review meetings. Interacting with cross-functional colleagues on document content and champions MW processes and best practices. Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.
+ Actively participating in or leading process working groups.
+ Coaching or mentoring more junior staff on document planning, processes, and content. Provides peer review as needed.
**Principal Relationships:**
+ Internal: manager, other writers cross-functional contacts (eg, clinical, regulatory, or biostatistical functions) involved in the preparation and planning of clinical documents.
+ External: May interact with or oversee day-to-day work by contractors or external service providers as needed under supervision. May collaborate with external partner company staff on codeveloped compounds.
**Qualifications / Requirements:**
+ A university/college degree in a scientific field is required. An advanced degree (eg, Masters, PhD, MD) is preferred.
+ At least 6 years of relevant pharmaceutical/scientific experience including at least 4 years of regulatory medical writing experience is required.
**Other:**
+ Recognizes how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in all document types under general supervision.
+ Proficiency in written and spoken English is essential, together with excellent oral and written communication skills.
+ Strong attention to detail.
+ Ability to collaborate with cross-functional global teams across time zones, requiring some flexibility in your daily routine.
+ Builds productive relationships with cross-functional team members.
+ Has strong leadership skills, both in project and process management as well as in time management (influencing, negotiating, assertiveness, taking initiative). Resolves complex problems under supervision.
+ Organizes time well, and demonstrates learning agility.
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):
+ Belgium, Netherlands, Germany: R-
+ United Kingdom- Requisition Number: R-
+ Unites States - Requisition Number: R-
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
**For United States applicants:**
The anticipated base pay range for this position is $105,000 to 169,050 (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
**The anticipated base pay range for this position is :**
105,000 to 169,050 USD
Additional Description for Pay Transparency:
View Now

Manager, X-TA Regulatory Medical Writing

19477 Spring House, Pennsylvania J&J Family of Companies

Posted 23 days ago

Job Viewed

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Job Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
Medical Affairs Group
**Job Sub** **Function:**
Medical Writing
**Job Category:**
People Leader
**All Job Posting Locations:**
Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America
**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-
Netherlands, Belgium- Requisition Number: R-
United States - Requisition Number: R-
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
**For United States applicants:**
The anticipated base pay range for this position is $115,000 to $97,000 (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
**The anticipated base pay range for this position is :**
115,000 - 197,800 (USD)
Additional Description for Pay Transparency:
View Now

Senior Analyst Regulatory Medical Writing, Immunology

19436 Gwynedd, Pennsylvania Johnson and Johnson

Posted 3 days ago

Job Viewed

Tap Again To Close

Job Description

Permanent

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

Job Function:

Medical Affairs Group

Job Sub Function:

Medical Writing

Job Category:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

Senior Analyst Regulatory Medical Writing, Immunology

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 Analyst Regulatory Medical Writing, within Integrated Data Analytics & Reporting (IDAR), to join our diverse team of medical writers for immunology indications. The role can be located High Wycombe, United Kingdom; Beerse, Belgium; Leiden, Netherlands; Neuss, Germany, or Springhouse / Raritan / Titusville, United States. Hybrid working is expected for applicants living within commutable distance of a J&J office (3 days onsite per week). Remote work options may be considered on a case-by-case basis for those outside tenable commutable area, and if approved by the company.

Are you ready to join our team? Then please read further!

You will be responsible for:

  • Writing or coordinating clinical and regulatory documents such as, but not limited to, CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents.

  • Leading cross-functional document planning and review meetings. Interacting with cross-functional colleagues on document content and champions MW processes and best practices. Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.

  • Actively participating in or leading process working groups.

  • Coaching or mentoring more junior staff on document planning, processes, and content. Provides peer review as needed.

Principal Relationships:

  • Internal: manager, other writers cross-functional contacts (eg, clinical, regulatory, or biostatistical functions) involved in the preparation and planning of clinical documents.

  • External: May interact with or oversee day-to-day work by contractors or external service providers as needed under supervision. May collaborate with external partner company staff on codeveloped compounds.

Qualifications / Requirements:

  • A university/college degree in a scientific field is required. An advanced degree (eg, Masters, PhD, MD) is preferred.

  • At least 6 years of relevant pharmaceutical/scientific experience including at least 4 years of regulatory medical writing experience is required.

Other:

  • Recognizes how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in all document types under general supervision.

  • Proficiency in written and spoken English is essential, together with excellent oral and written communication skills.

  • Strong attention to detail.

  • Ability to collaborate with cross-functional global teams across time zones, requiring some flexibility in your daily routine.

  • Builds productive relationships with cross-functional team members.

  • Has strong leadership skills, both in project and process management as well as in time management (influencing, negotiating, assertiveness, taking initiative). Resolves complex problems under supervision.

  • Organizes time well, and demonstrates learning agility.

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):

  • Belgium, Netherlands, Germany: R-

  • United Kingdom- Requisition Number: R-

  • Unites States - Requisition Number: R-

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

For United States applicants: 

The anticipated base pay range for this position is $105,000 to 169,050 (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-R emote 

The anticipated base pay range for this position is :

105,000 to 169,050 USD

Additional Description for Pay Transparency:

Apply Now

Manager, X-TA Regulatory Medical Writing

19436 Gwynedd, Pennsylvania Johnson and Johnson

Posted 23 days ago

Job Viewed

Tap Again To Close

Job Description

Permanent

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

Job Function:

Medical Affairs Group

Job Sub Function:

Medical Writing

Job Category:

People Leader

All Job Posting Locations:

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

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-

Netherlands, Belgium- Requisition Number: R-

United States - Requisition Number: R-

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

For United States applicants:

The anticipated base pay range for this position is $115,000 to $97,000 (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

The anticipated base pay range for this position is :

$115,0 0 - 197,800 (USD)

Additional Description for Pay Transparency:

Apply Now

Associate Director, X-TA Regulatory Medical Writing

19477 Spring House, Pennsylvania J&J Family of Companies

Posted 22 days ago

Job Viewed

Tap Again To Close

Job Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
Medical Affairs Group
**Job Sub** **Function:**
Medical Writing
**Job Category:**
People Leader
**All Job Posting Locations:**
Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America
**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-
Europe (BE/FR/DE/IRE/IT/NL/ES)- Requisition Number: R-
United States (East Coast)- Requisition Number: R-
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
**For United States applicants:**
The anticipated base pay range for this position is $137,000 to $235,750 (USD)
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the 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
**The anticipated base pay range for this position is :**
137,000-235,750 USD
Additional Description for Pay Transparency:
View Now

Associate Director, X-TA Regulatory Medical Writing

19477 Spring House, Pennsylvania Johnson and Johnson

Posted 23 days ago

Job Viewed

Tap Again To Close

Job Description

Permanent

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

Job Function:

Medical Affairs Group

Job Sub Function:

Medical Writing

Job Category:

People Leader

All Job Posting Locations:

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

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-

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

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

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

For United States applicants:

The anticipated base pay range for this position is $137,000 to $235,750 (USD)

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the 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

The anticipated base pay range for this position is :

137,000-235,750 USD

Additional Description for Pay Transparency:

Apply Now
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About the latest Medical writers Jobs in United States !

Senior Manager/Associate Director, Regulatory Medical Writing, Immunology

19477 Spring House, Pennsylvania Johnson and Johnson

Posted 26 days ago

Job Viewed

Tap Again To Close

Job Description

Permanent

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

Job Function:

Medical Affairs Group

Job Sub Function:

Medical Writing

Job Category:

People Leader

All Job Posting Locations:

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time. 

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. 

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at are searching for the best talent for a Senior Manager/Associate Director , Regulatory Medical Writing within our Integrated Data Analytics & Reporting (IDAR) business. This role will support our Immunology Regulatory Medical Writing area. 

The position can be located at any of our following offices: High Wycombe (UK), Beerse (Belgium), Leiden (Netherlands), Allschwil (Switzerland), or Spring House/Raritan/Titusville (East Coast US).

Hybrid (3 days per week onsite) is strongly preferred. Remote work options may be considered on a case-by-case basis and if approved by the company.  

You will be responsible for: 

  • Leading compound/submission/indication/disease area writing teams independently. 
  • Directly leading or setting objectives for others on team projects and tasks, eg, able to lead Medical Writing (MW) process working groups or Communities of Practice.
  • Writing or coordinating all types of clinical and regulatory documents, taking a proactive or lead role in terms of content and scientific strategy.
  • Establishing and driving document timelines and strategies independently.
  • Guiding or training cross-functional team members on processes and best practices.
  • Proactively identifying and championing departmental process improvements.
  • May lead cross-functional, cross-therapy area, or cross-J&J process improvement initiatives.
  • Leading discussions in MW and cross-functional meetings as appropriate (eg, submission team meetings, Global Program Team meetings, study team meetings, clinical team meetings).
  • Maintaining and disseminating knowledge of industry, company, and regulatory guidelines.
  • Interacting with senior cross-functional colleagues and external partners to strengthen coordination between departments.

As a people manager:

  • Supervising/managing and being accountable for direct reports.
  • Setting objectives and agreeing on goals for direct reports. Providing performance oversight, including feedback on performance and development. 
  • Regularly meeting with direct reports to ensure appropriate development, projects, assignments, and issues are resolved. 
  • Coaching or mentoring more junior writers on document planning, processes, content, and provides peer review as needed.
  • Ensuring direct report’s adherence to established policies, procedural documents, and templates. 
  • Participating in hiring staff, onboarding new staff, conducting career and talent development discussions for staff, goal-setting, end-of-year performance reviews, and compensation planning. 

Qualifications /Requirements: 

  • A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred. 
  • At least 10 years of relevant pharmaceutical/scientific experience.
  • At least 8 years of relevant clinical/regulatory medical writing experience.
  • At least 2 years of direct people management experience. 
  • Experience in project management and process improvement.
  • Advanced knowledge and application of regulatory guidance such as ICH requirements
  • Recognizes how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
  • Resolves complex problems independently.
  • Proactively identifies potential risks and develops strategies to mitigate.
  • Ability to serve as the liaison between team members and senior leadership within a therapy area.
  • Ability to build and maintain solid and positive relationships with cross-functional team members.
  • Excellent oral and written communication skills.
  • Attention to detail.
  • Expert time management for self and team.
  • Expert project management skills, expert project/process leadership.
  • Strong leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management).
  • Ability to delegate responsibility to junior writers.
  • Ability to lead by example, stay focused and positive, and act with integrity.
  • Ability to internalize and teach CREDO behaviours.
  • Ability to act as change agent and adapt to rapidly changing organizational & business challenges.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): 

  • United Kingdom - Requisition Number: R-
  • Belgium, Netherlands - Requisition Number: R-
  • Switzerland - Requisition Number: R- 
  • United States - Requisition Number: R-

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. 

For United States applicants: 

The anticipated base pay range for this position is $137,000 to $235,750 (USD).  

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.  

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, denta l, 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 

The anticipated base pay range for this position is :

137,000 - 235,700 USD

Additional Description for Pay Transparency:

Apply Now

Senior Manager/Associate Director, Regulatory Medical Writing X-TA

08560 Titusville, New Jersey J&J Family of Companies

Posted 23 days ago

Job Viewed

Tap Again To Close

Job Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
Medical Affairs Group
**Job Sub** **Function:**
Medical Writing
**Job Category:**
People Leader
**All Job Posting Locations:**
Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America
**Job Description:**
**Senior Manager/Associate Director, Regulatory Medical Writing X-TA**
At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time.
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at are searching for the best talent for a **Senior Manager** **/Associate Director** , **Regulatory Medical Writing** within our Integrated Data Analytics & Reporting (IDAR) business. This role will support one or more of our therapeutic areas within the X-TA (Cross Therapeutic Area) Regulatory Medical Writing area.
**The position can be** **located** **at any of our following offices: High Wycombe (UK), Beerse (Belgium), Leiden (Netherlands),** **Allschwil** **(Switzerland) or Spring** **House/Raritan/Titusville** **(East Coast US).**
Hybrid (3 days per week onsite) is strongly preferred. Remote work options may be considered on a case-by-case basis and if approved by the company.
_Are you ready to join our team? Then please read further!_
**You will** **be responsible for** **:**
+ Leading compound/submission/indication/disease area writing teams independently.
+ May have additional major responsibility with supervision.
+ Cross-functional, cross-TA, or cross-J&J initiative/collaboration.
+ Larger organizational responsibility (eg, manage a subset of TA).
+ Preparing and finalizing all types of clinical documents, taking a proactive or lead role in terms of content and scientific strategy. Working with a high level of independence and taking a lead role on with respect to timing, scheduling, and tracking.
+ Leading program-level/submission writing teams independently.
+ Directly leading or setting objectives for others on team projects and tasks.
+ Guiding or training cross‐functional team members on processes, best practices; coach or mentor more junior writers.
+ Proactively identifying, contributing to and championing Medical Writing process improvements, internal standards, regulatory, and publishing guidelines, internal systems, tools, and processes.
+ Leading cross‐functional/cross‐TA, cross‐J&J process improvement initiatives, or other large process working groups.
+ Developing, maintaining and disseminating knowledge of industry, company, and regulatory guidelines to internal and external audiences.
+ If a lead writer for a program:
+ Primary point of contact and champion for Medical Writing activities for the clinical team.
+ Responsible for planning and leading the writing group for assigned program.
+ Able to function as a lead writer on any compound independently.
+ Leading discussions in Medical Writing and cross‐functional meetings as appropriate.
+ Interacting with senior cross‐functional colleagues and external partners to strengthen coordination between departments.
+ Able to oversee the work of external contractors.
+ As a people manager:
+ Manage direct reports in Medical Writing.
+ Set objectives for individual team members. Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
+ Ensures direct report's adherence to established policies, procedural documents, and templates
+ Able to make decision on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, lead in goal setting and performance discussions.
**Qualifications /Requirements:**
+ University/college degree in a scientific discipline is required. Masters or PhD preferred.
+ At least 10 years of relevant pharmaceutical/scientific experience; at least 8 years of relevant Medical Writing experience is required!
+ At least 2 years of people management experience.
+ Multiple therapeutic area experience preferred.
+ Strong attention to detail.
+ Strong oral and written communication skills. Fluent written and spoken English.
+ Expert project management skills, expert project/process improvement leadership.
+ Expert leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management). Strong people management skills.
+ Ability to delegate responsibility to junior writers.
+ Demonstrated ability to collaborate and develop effective partnerships with key business partners and customers.
+ Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
+ United Kingdom - Requisition Number: R-
+ Belgium, Netherlands - Requisition Number: R-
+ Switzerland - Requisition Number: R-
+ United States - Requisition Number: R-
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
**For United States applicants:**
The anticipated base pay range for this position is $137,000 to $35,750 (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
**The anticipated base pay range for this position is :**
137,000 to 235,750 (USD)
Additional Description for Pay Transparency:
View Now

Senior Manager/Associate Director, Regulatory Medical Writing X-TA

08560 Titusville, New Jersey Johnson and Johnson

Posted 24 days ago

Job Viewed

Tap Again To Close

Job Description

Permanent

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

Job Function:

Medical Affairs Group

Job Sub Function:

Medical Writing

Job Category:

People Leader

All Job Posting Locations:

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

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 cross‐functional team members on processes, best practices; coach or mentor more junior writers. 

  • Proactively identifying, contributing to and championing Medical Writing process improvements, internal standards, regulatory, and publishing guidelines, internal systems, tools, and processes. 

  • Leading cross‐functional/cross‐TA, cross‐J&J process improvement initiatives, or other large process working groups. 

  • Developing, maintaining and disseminating knowledge of industry, company, and regulatory guidelines to internal and external audiences. 

  • If a lead writer for a program: 

  • Primary point of contact and champion for Medical Writing activities for the clinical team. 

  • Responsible for planning and leading the writing group for assigned program. 

  • Able to function as a lead writer on any compound independently. 

  • Leading discussions in Medical Writing and cross‐functional meetings as appropriate. 

  • Interacting with senior cross‐functional colleagues and external partners to strengthen coordination between departments. 

  • Able to oversee the work of external contractors. 

  • As a people manager: 

  • Manage direct reports in Medical Writing. 

  • Set objectives for individual team members. Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved. 

  • Ensures direct report’s adherence to established policies, procedural documents, and templates 

  • Able to make decision on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, lead in goal setting and performance discussions. 

Qualifications /Requirements: 

  • University/college degree in a scientific discipline is required. Masters or PhD preferred. 

  • At least 10 years of relevant pharmaceutical/scientific experience; at least 8 years of relevant Medical Writing experience is required! 

  • At least 2 years of people management experience. 

  • Multiple therapeutic area experience preferred. 

  • Strong attention to detail. 

  • Strong oral and written communication skills. Fluent written and spoken English. 

  • Expert project management skills, expert project/process improvement leadership. 

  • Expert leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management). Strong people management skills. 

  • Ability to delegate responsibility to junior writers. 

  • Demonstrated ability to collaborate and develop effective partnerships with key business partners and customers. 

  • Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently. 

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): 

    • United Kingdom - Requisition Number: R-  
    • Belgium, Netherlands - Requisition Number: R-
    • Switzerland - Requisition Number: R-  
    • United States - Requisition Number: R-

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. 

For United States applicants: 

The anticipated base pay range for this position is $137,000 to $35,750 (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:

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 

The anticipated base pay range for this position is :

$137,000 to $235,750 (USD)< >Additional Description for Pay Transparency:

Apply Now
 

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