The Senior Strategic Medical Writer is responsible for leading and writing clinical and regulatory documents for drug and/or device development in support of company objectives.
Responsibilities:
- Prepares clinical and regulatory documents needed for the development of AbbVie drugs and/or devices.
- Functions with a moderate degree of autonomy on draft materials but relies on review by subject matter experts and more senior writers for verification. Develop knowledge and understanding of submission strategies.
- Coordinates the review, approval, and quality control of other functions involved in the production of clinical and regulatory projects. Arranges and conducts review meetings with the team.
- Produces and maintains clinical and regulatory documents focusing on quality and compliance and ensures delivery within project timelines. Develops understanding of project management concepts and accepts greater responsibility for driving submission objectives.
- Develops knowledge of US and international regulations, requirements, and guidelines pertaining to the preparation of regulatory documentation. Understands and uses guidance associated with preparation of regulatory documentation.
- Participates in execution of tactical process improvements.
- Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
- Works closely with leadership and R&D Quality Assurance to address inquiries and draft responses, supporting an inspection-ready approach.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required