Jobleads-US
Redwood City, CA, USA
The Associate Director, Medical Writing will collaborate with colleagues to write high-quality, strategically aligned medical-writing deliverables supporting the regulatory requirements of a clinical development program, ensuring completeness, accuracy, and compliance with US and ex-US regulatory requirements.
Responsibilities:
Author, co-author, critically edit, and format clinical/regulatory documents, including New Drug Applications (NDAs), protocols/protocol amendments, clinical study reports (CSRs), Investigator’s Brochures, administrative letters, and other regulatory submissions as needed.
Interact with document authors, contributors, and reviewers (including members of Biometrics, Clinical Operations, Clinical Development, Project Management, CMC, Drug Safety, and Regulatory Affairs) to acquire necessary input into documents.
Develop and manage medical writing timelines for assigned documents to ensure on-time deliverables that meet business needs.
Facilitate...