Principal Medical Writer
Core
Lead end-to-end authoring of complex clinical and post-market safety documents (e.g., DSURs, RMPs) for regulatory use, translating safety data into clear outputs.
Role type
Principal Medical Writer (Regulatory Safety)
Builds
Regulatory safety dossiers and aggregate reports for global health authorities
Domain
Pharmaceutical / Biotech / Pharmacovigilance
Required skills
Advanced medical/regulatory safety writing, Statistical interpretation, Regulatory guidance knowledge (ICH, GVP, FDA, EMA), Cross-functional collaboration, Vendor oversight, Project management, Therapeutic area expertise
Preferred skills
Advanced degree (PhD, PharmD, MSc), Dossier module preparation, Statistical collaboration, Mentoring experience, Multicultural team leadership
Technologies
Authoring/review tools, Automation/AI-enabled platforms
Responsibilities
Independently lead preparation of complex clinical and post-market safety documents, Operate within a global matrix organization influencing stakeholders, Lead cross-functional teams to develop content strategy, Provide oversight to co-authors and vendor writers, Drive continuous improvement in writing processes
Seniority
Principal, hands-on IC with strategic influence