Manager Regulatory Medical Writing (Medical Writing)

Location: Hybrid, with three 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: €68,600–€119,600 in the Netherlands; €79,800–€137,770 in Belgium; €60,400–€103,960 in France; €78,300–€135,700 in Germany.

Company

Healthcare organization developing medicines, MedTech solutions, and innovative treatments across the healthcare spectrum.

What you will do

• Prepare and finalize clinical and regulatory documents across multiple therapeutic areas.
• Lead assigned writing projects, including content, scientific strategy, timelines, scheduling, and tracking.
• Lead project-level, submission, or indication writing teams and act as the primary medical writing contact for assigned programs.
• Guide and train cross-functional colleagues on medical writing processes and best practices.
• Coach and mentor junior medical writers while overseeing external contractors and document specialists.
• Recommend departmental process improvements and represent Medical Writing in relevant industry standards groups.

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.
• Fluent English with excellent written and oral communication skills.
• Strong project, time, and process leadership skills, with the ability to resolve complex problems independently.
• Knowledge and application of regulatory guidance, including ICH requirements, and the ability to interpret and present statistical and medical information accurately.
• Ability to commute to the site and work onsite three days per week is required.

Nice to have

• Submission leadership experience.
• Experience across multiple therapeutic areas.
• Experience with clinical research, clinical trial operations, coaching, data synthesis, proofreading, quality validation, or standard operating procedures.

Culture & Benefits

• Inclusive work environment focused on healthcare innovation and patient impact.
• Annual bonus based on pay grade, location, and individual and company performance.
• Vacation, parental leave of at least 12 weeks, bereavement leave, caregiver leave, and volunteer leave.
• Well-being reimbursement and financial, physical, and mental health programs.
• Recognition awards and access to insurance plans, subject to local plan terms.