Job Description
Overview
We are seeking an experienced Senior Medical Writer to lead the development of high-quality clinical and regulatory documents supporting global regulatory submissions. This role plays a critical part in ensuring that documents such as Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), and marketing authorization applications (MAAs/NDAs/BLAs) are scientifically accurate, consistent, and aligned with program objectives and global regulatory requirements.
The successful candidate will act as a lead writer for key summary documents, providing strategic guidance to cross-functional teams while overseeing medical writing activities across multiple compounds. This position reports to the Director of Medical Writing (or above)
Key Responsibilities
Lead the development of high-quality clinical and regulatory documents (e.g., Investigator’s Brochures, Clinical Study Reports, clinical summaries, and mark...
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