Manager, Medical Writing FSP
Core
Manage a team of Medical Writers to ensure operational excellence, resource planning, and delivery of high-quality regulatory and clinical documents.
Role type
Manager, Medical Writing
Builds
Regulatory submissions (IND, NDA, CTD), clinical study reports, and departmental training programs
Domain
Life Sciences / Pharmaceutical / Medical Writing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical writing, resource planning, team supervision, regulatory compliance (ICH/FDA), budgeting, proposal development, data interpretation
Preferred skills
Advanced degree (PharmD, PhD, Masters), pharmaceutical industry experience
Technologies
None stated
Responsibilities
Supervise Medical Writers and assign projects; Review and approve deliverables for timeliness and quality; Prepare marketing presentations and client proposals; Develop training programs; Interpret clinical data for regulatory submissions
Seniority
Manager, hands-on leadership
