What are the responsibilities and job description for the Manager Medical Writing position at Meet?
Position Overview :
We are seeking a Manager in Medical Writing to oversee the development of clinical regulatory documentation supporting drug development and regulatory filings. This role will focus on writing, revising, and managing high-quality materials while ensuring compliance with regulatory standards for submissions. The ideal candidate will have experience in regulatory submissions, including NDA, BLA, IND, CTA, and clinical document writing such as IB, CRS, and briefing books. The position requires candidates to be located in the Eastern or Central Time Zone.
Core Responsibilities :
- Lead the creation and revision of clinical regulatory documents, including submission summaries and key materials for drug development and regulatory submissions.
- Ensure all documents are thorough, precise, and comply with global regulatory guidelines and best practices, focusing on NDA, BLA, IND, and CTA submissions.
- Manage internal teams, contingent workers, and vendors, providing strategic direction to ensure efficient development of regulatory documents.
- Contribute to the creation of document templates and process improvements to enhance document quality and operational efficiency.
- Collaborate closely with cross-functional teams to ensure regulatory documentation aligns with submission requirements and global regulatory standards.
Required Qualifications :
This position does not offer work visa sponsorship.
