Manager Regulatory Medical Writing XTA

Location: Hybrid, with three days onsite weekly. Available in High Wycombe, United Kingdom; Leiden, Netherlands; Neuss, Germany; Paris, France; Beerse, Belgium; or Horsham, Spring House, and Raritan, United States. Remote work may be considered case by case if approved.

Company

Johnson & Johnson MedTech develops healthcare solutions and treatments designed to improve patient outcomes.

What you will do

• Prepare and finalize clinical and regulatory documents across multiple therapeutic areas.
• Lead assigned projects, managing content strategy, timelines, schedules, tracking, and deliverables.
• Lead writing teams for programs, submissions, indications, or process-improvement initiatives.
• Serve as the primary medical writing contact for clinical teams when acting as lead writer.
• Guide, train, coach, and mentor cross-functional team members and junior medical writers.
• Coordinate with senior cross-functional colleagues and contribute to industry standards working groups.

Requirements

• University or college degree required; a master's degree 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.
• Expert project and time management, project leadership, and process leadership skills.
• Ability to interpret, summarize, and present statistical and medical information accurately; 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, coaching, data synthesis, SOPs, proofreading, and process improvements.

Culture & Benefits

• Inclusive work environment that values individual contributions, diversity, and dignity.
• Competitive salary and extensive benefits package.
• Reasonable accommodations are available during the application, interview, and employment process.