Senior Medical Writing and Operations Specialist
6 days ago
Role Summary
This is an exciting opportunity to join our team as an Associate Director, Medical Writing Asset Lead. You will be responsible for leading a team in creating high-quality clinical documents for regulatory submissions.
Main Responsibilities:
- Develop Clinical Documents: Develop and implement medical writing strategies for clinical programs and content of documents.
- Lead Cross-Functional Teams: Lead matrix teams to deliver high-quality, fit-for-purpose clinical documents that accurately reflect associated data and are in line with global/regional/local regulatory requirements.
- Collaborate with Global Regulatory Affairs: Collaborate with stakeholders to provide significant contributions to complex clinical submission documents and ensure timely dissemination of information.
- Ensure Quality and Compliance: Ensure quality and compliance of clinical documents and processes, including consistency, regulatory compliance, and good writing practices.
What You Need
- Master's or doctoral degree in a relevant field (Pharmaceutical sciences, biology, chemistry, etc.).
- At least 6 years of experience in clinical regulatory writing in the pharmaceutical industry.
- Proven track record in writing clinical documents in scope and project management, planning, communication, and matrix leadership.
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