FSP Associate Director Medical Writing
Core
Oversees regional Medical Writing staff and projects, ensuring quality delivery within timelines while managing budgets and business development.
Role type
Senior management medical writing director
Builds
Medical writing deliverables for clinical trials and regulatory submissions
Domain
Life sciences / Clinical research / Regulatory affairs
Required skills
Strategic planning, team leadership, budget management, business development, project oversight, regulatory knowledge, process improvement, client relations, financial forecasting, cross-functional collaboration
Preferred skills
Advanced degree (PharmD, PhD, Masters), 10+ years experience, 5+ years management responsibility
Technologies
PPD SOPs, Client SOPs, clinical trial guidelines, regulatory submission standards
Responsibilities
Manage workload, resources, and staff allocation; recruit, train, and develop team members; monitor departmental spending; identify new business opportunities and manage project pricing; lead operational excellence and process improvements; oversee complex projects and escalate risks; prepare client presentations and bid defenses; collaborate with internal departments (Phase I, PK, biostatistics, PVG, regulatory).
Seniority
Director, strategic leadership & team management