What are the responsibilities and job description for the SENIOR MANAGER, MEDICAL WRITING position at BeiGene?
Job Summary :
The Senior Manager, Medical Writing is responsible for writing, editing, and formatting clinical regulatory documents that conform to domestic and / or international regulatory submission and internal document standards, while meeting project timelines and to oversee these activities in more junior medical writers. Clinical regulatory documents include, but are not limited to study reports, clinical study protocols or amendments, investigator brochures, and clinical sections of INDs, NDAs, MAAs and other regulatory submission documents. The Manager, or Senior Manager, Medical Writing is also responsible for mentoring junior writers and managing direct reports, if applicable.
Essential Functions of the job :
- Works effectively with cross-functional groups to produce high-quality, scientifically accurate documents under strict timelines, and ensures consistency between related documents
- Responsible for ensuring that assigned documents undergo a quality check before approval, and that documents are routed correctly during review and approval cycles
- Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables
- Review and edit documents, including those authored by others both internally and externally
- Collaborate within the medical writing group to develop and maintain medical writing processes, standards, and tools (eg, SOPs, Work Instructions, templates, style guide, etc.)
- Ensure clinical documents adhere to BeiGene standards and regulatory guidelines
- Manage and mentor direct reports as applicable
- Coordinate and manage contract medical writers as needed
Qualifications : Knowledge and Skills
Supervisory Responsibilities :
Computer Skills :
Education / Experience Required :
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
