Summary: The Lead Medical Writer will serve as the medical writing lead for the preparation of a variety of clinical documents, including but not limited to CSRs, Investigator's Brochures, and protocols, for regulatory/clinical purposes at an emerging biotechnology company focused in neurodegenerative diseases in the CNS space.
The Lead Medical Writer will be responsible for:
- Serving as principal writer for and coordinating development of clinical protocols/amendments, clinical study reports (CSRs), investigator's brochures, Module 2 summaries, as well as any other regulatory submissions as needed for assigned programs.
- Ensuring adherence to clinical/regulatory timelines, standards, and processes, as well as developing them in line with SOPs
- Guiding medical writing and cross-functional initiatives relating to processes, template development and document standards
- Collaborate with clinical development and clinical operation to ensure alignment with program objectives.
The Lead Medical Writer should have the following qualifications:
- A Bachelor's, Master's, PharmD or Ph.D. in a life sciences or related field preferred.
- A minimum of 10 years' pharmaceutical and/or biotechnology industry experience within the clinical/regulatory medical writing space
- Knowledge of ICH guidelines, GxP, and other relevant regulatory requirements
- Experience independently authoring standard clinical document types, including but not limited to CSRs, investigator's brochures and protocols
If you interested in the Lead Medical Writing position, then don't wait to apply!