Here’s What You’ll Do:
- Functional Knowledge: Possess specialized depth and breadth of knowledge for managing medical writing and regulatory writing within a clinical development program.
- Document Planning and Project Management: Coordinate and oversee the planning, writing, editing, and review of clinical and regulatory documents.
- Cross-functional Collaboration: Work closely with the clinical development team and other departments to ensure alignment and coherence of documents.
- Regulatory Compliance: Ensure that all documents comply with regulatory guidelines and standards.
- Data Interpretation: Understand and interpret complex clinical data and other scientific information.
- Quality Control: Establish and maintain processes to ensure the quality of documents.
- Here’s What You’ll Bring to the Table:
- Education and Years of Experience: Advanced degree (preferred) with approximately 7 years of relevant experience OR bachelor’s degree with approximately 12 years of relevant experience.
- Interpersonal Skills: Excellent interpersonal skills to effectively communicate and collaborate with all levels of the organization.