Manager Medical Writing XTA

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 innovate across the full spectrum of healthcare solutions to deliver breakthroughs that profoundly impact health for humanity.

About the role

We are searching for a Manager, Regulatory Medical Writing to support key therapeutic areas within our Integrated Data Analytics & Reporting (IDAR) business. This position may be located in the UK (High Wycombe), Netherlands (Leiden), Germany (Neuss), France (Paris), Belgium (Beerse), or the United States (Horsham, PA; Spring House, PA; Raritan, NJ). The role is hybrid, requiring 3 days onsite weekly. Remote work options may be considered on a case-by-case basis.

Responsibilities

• Prepare and finalize all types of clinical documents.
• Lead in a team environment with a high level of independence, taking a lead role on assigned projects regarding content, scientific strategy, timing, scheduling, and tracking.
• Set objectives for others on team projects and tasks, including leading process working groups.
• Guide or train cross-functional team members on processes and best practices.
• Potentially lead project-level, submission, or indication writing teams.
• Proactively provide recommendations for departmental process improvements.
• As a lead writer for a program:
  • Serve as the primary point of contact and champion for medical writing activities for the clinical team.
  • Plan and lead the writing group for the assigned program.
  • Actively participate in medical writing and cross-functional meetings.
  • Maintain knowledge of industry, company, and regulatory guidelines.
  • Coach or mentor junior staff on document planning, processes, and content; provide peer review and oversee the work of other medical writers, external contractors, and document specialists.
  • Interact with senior cross-functional colleagues to strengthen coordination between departments.
  • Represent the Medical Writing department in industry standards working groups.

Requirements

• University/college degree required; Master’s or PhD preferred.
• At least 8 years of relevant pharmaceutical/scientific experience; at least 6 years of relevant medical writing experience.
• Submission leadership experience preferred.
• Experience in multiple therapeutic areas preferred.
• Excellent attention to detail.
• Strong oral and written communication skills; English fluency required.
• Expert project and time management skills.
• Strong project and process leadership skills.
• Ability to interpret, summarize, and present statistical and medical information accurately.
• Ability to resolve complex problems independently.
• Demonstrated learning agility.
• Ability to build and maintain positive relationships with cross-functional team members.
• Solid knowledge and application of regulatory guidance documents such as ICH requirements.
• Ability to commute to the site.

Benefits

• Annual base pay range: $117,000 to $201,250 USD (1.0 FTE basis).
• Eligibility for an annual performance bonus in accordance with the applicable plan.
• Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Participation in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Time off benefits:
  • Vacation – up to 120 hours per calendar year.
  • Sick time – up to 40 hours per calendar year (56 hours for employees in Washington State).
  • Holiday pay, including Floating Holidays – up to 13 days per calendar year.
  • Work, Personal, and Family Time – up to 40 hours per calendar year.

Skills

• Medical Writing
• Regulatory Writing
• Submission Management
• Business Writing
• Clinical Research and Regulations
• Clinical Trials Operations
• Coaching
• Collaboration
• Copy Editing
• Data Synthesis
• Industry Analysis
• Medical Affairs
• Medical Communications
• Process Improvements
• Proofreading
• Quality Validation
• Standard Operating Procedure (SOP)
• Tactical Planning
• Technical Credibility