Associate Director, Medical Writing - Biogen, Cambridge, MA
- Cambridge, MA
- Department: Research & Development
- Region: US
The Associate Director, Medical Writing provides leadership and functional oversight for one or more clinical program. This person functions as a strong project manager and technical leader, with demonstrated scientific and customer-focused leadership skills. They will direct medical writers in the preparation of clinical regulatory documents, including clinical summaries/overviews for marketing applications (including global markets and emerging markets) and clinical trial applications (INDs/CTAs). Will also partner with R&D departments to ensure timely completion of high-quality clinical regulatory documents. The AD, Medical Writing is required to have expert knowledge of global requirements related to all aspects of clinical regulatory documentation to support all phases of clinical development (Phase 1-4), and acts as a medical writing subject matter expert to other departments.
This person will provide mentoring and career development to direct reports, provide leadership in the development of Global Medical Writing processes and standards, and performs outreach within pharmaceutical/biotech industry to maintain knowledge of evolving/emerging industry standards and to establish medical writing best practices within company.
- Provides Medical Writing leadership for a clinical program. Acts as a medical writing subject matter expert and works with clinical development team to deliver on medical writing program goals
- Is responsible for managing medical writing deliverable for a clinical program. Provides guidance to internal and external writers on prioritization, content and timeline development, and process management.
- Is a senior leader of the Global Medical Writing Dept. Provides leadership and contributes to overall department strategies and initiatives. Plans and allocates resources as appropriate and ensures resource alignment with program needs.
- Maintains cutting edge knowledge base of current developments in field and related technologies. Incorporates process improvements and changes that align with R&D needs. Develops training programs and processes that ensure medical writing staff learn and develop program-specific knowledge.
- Contributes to a culture of customer focus and continual process improvement. Manages process re-design(s) that ensure fast-pace program milestones are met and high-quality clinical regulatory documentation is produced.
- 8+ years regulatory writing and management experience.
- Expert knowledge of standard clinical regulatory document types.
- Experience working in relevant therapeutic areas.
- Experienced in resource planning and management experience with virtual teams, employees based in field locations, and functional service providers.
Masters or PhD in life or health science discipline.
All your information will be kept confidential according to EEO guidelines.
Contact Person: Vera Buris, Senior Manager, Global Safety and Regulatory Sciences (GSRS)
Assignment Date: 02/10/2021
Location: 300 Binney Street, 93C27, Cambridge, MA 02142