Medical Writer I (Remote)

The Medical Writer I will provide technical and operational support for scientific writing activities and projects, including authoring, editing, and contributing to nonclinical and clinical documents, regulatory submission documents, presentations, posters, publications, and regulatory fulfillment. This role involves cross-functional collaboration with internal departments and external resources on scientific writing matters. The incumbent will work with multifunctional teams to prepare documents such as nonclinical reports, clinical study reports (CSRs), protocols, protocol amendments, briefing documents, Investigator Brochures (IBs), safety updates, agency responses, and summary modules under strict timelines, supporting key regulatory submissions to US and global health authorities. Responsibilities also include ensuring clarity and consistency of key messages within and across documents, assisting with strategic and scientific contributions at the project and/or study team level, providing editorial or review support for abstracts, manuscripts, posters, and presentations, and collaborating with cross-functional team members to ensure accurate and timely completion of high-quality, scientifically justified documents. The role requires ensuring consistent document presentation style, assisting in day-to-day operational activities, and performing other assignments as specified by management.