Principal Medical Writer

Role: Scientific writer specializing in clinical and regulatory documents to support biotech product development. Responsibilities: develop and manage high-quality documents (protocols, IBs, clinical reports, regulatory submissions) ensuring compliance with regulations and internal standards; mentor junior staff; lead document project timelines, identify risks, and collaborate with study and program teams; optimize processes and tools; contribute to training and knowledge sharing within the department. Requirements: advanced degree (MS/PhD/PharmD/MD) in life sciences; 4+ years (MS) or 2+ years (PhD/MD) regulatory writing experience; proficiency in Microsoft Word, Adobe Acrobat, and document management systems; strong project management and cross-functional collaboration skills. HighValue: experience with global regulatory submissions (INDs, NDAs, BLAs, MAAs); focus on cancer therapeutics; ability to manage complex, multi-document projects; occasional travel. WorkSetup: primarily remote with occasional travel.