Position Summary:
We are seeking an experienced and highly motivated Associate Director, Medical Writing to join our Regulatory/Clinical Development team. This leadership role is responsible for the strategic planning, preparation, and delivery of high-quality clinical and regulatory documents in support of global drug development programs. The ideal candidate will have deep experience in authoring and managing a wide range of regulatory and clinical documents, including clinical study protocols, clinical study reports (CSRs), Investigator’s Brochures (IBs), Development Safety Update Reports (DSURs), and US regulatory submissions (e.g., INDs, FDA meeting packages).
Key Responsibilities:
Qualifications:
Preferred Qualifications:
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