Manager Medical Writing XTA (Regulatory Writing)

Location: Hybrid, with 3 days onsite weekly, in High Wycombe, UK; Leiden, Netherlands; Neuss, Germany; Paris, France; Beerse, Belgium; or Horsham, Spring House, or Raritan, United States. Remote work may be considered case by case with company approval.

Annual base pay in the United States: $117,000–$201,250 USD.

Company

Johnson & Johnson MedTech develops healthcare solutions and treatments across Innovative Medicine and MedTech.

What you will do

• Prepare and finalize clinical and regulatory documents across multiple therapeutic areas.
• Lead assigned writing projects, defining content and scientific strategy, schedules, timelines, and tracking.
• Serve as the primary medical writing contact for assigned clinical programs and lead writing groups when applicable.
• Guide, train, coach, and mentor cross-functional team members and junior medical writers.
• Coordinate medical writers, external contractors, document specialists, and senior cross-functional stakeholders.
• Recommend departmental process improvements and represent Medical Writing in industry standards working groups when needed.

Requirements

• University or college degree required; a Master’s or PhD is preferred.
• At least 8 years of relevant pharmaceutical or scientific experience, including at least 6 years of medical writing experience.
• Excellent oral and written communication skills; English fluency is required.
• Strong project, time, process, and team leadership skills.
• Ability to interpret, summarize, and present statistical and medical information accurately and resolve complex problems independently.
• Knowledge and application of regulatory guidance, including ICH requirements, and ability to commute to the assigned site.

Nice to have

• Submission leadership experience.
• Experience across multiple therapeutic areas.
• Experience with clinical research, clinical trial operations, medical communications, process improvement, or SOPs.

Culture & Benefits

• Inclusive environment focused on healthcare innovation and patient impact.
• Performance-based annual bonus eligibility.
• Medical, dental, vision, life insurance, disability, accident, and group legal insurance may be available to eligible employees and dependents.
• Retirement pension and 401(k) savings plan eligibility in the United States.
• Vacation, sick time, holiday pay, and personal and family time benefits.