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Manager/ Senior Manager Regulatory Medical Writing

Job description

Manager/Senior Manager, Medical Writing (Remote)
Must be based in the US or Canada
 
A growing global regulatory writing group is seeking a Medical Writing Manager to both lead and mentor a team of medical writers supporting clinical development programs across a range of therapeutic areas. This is an excellent opportunity to join a collaborative, people-first environment where writers are seen as strategic contributors—not just content producers. The ideal candidate will be comfortable balancing leadership responsibilities with hands-on writing and oversight across complex regulatory projects.

Responsibilities
  • Provide line management and professional development oversight for a group of medical writers
  • Lead resource planning, team meetings, and performance reviews
  • Ensure time and utilization tracking for direct reports
  • Foster team engagement, reinforce shared values, and contribute to company culture
  • Represent the writing team in broader organizational strategy and business development efforts (e.g. external speaking engagements, client meetings)
  • Maintain a partial writing workload across regulatory documentation projects (reduced to support managerial responsibilities)
Qualifications
  • 8+ years of regulatory medical writing experience in pharma/biotech/CRO settings
  • 2+ years of direct line-management experience overseeing medical writers
  • Proven track record as Lead Medical Writer on complex regulatory submissions or global document packages
  • Strong experience with project-level planning, cross-functional collaboration, and quality oversight
  • Excellent interpersonal skills, team leadership, and communication abilities
  • Experience in evaluating resource needs and cost-benefit analysis for workload distribution and project planning