Medical reputed company, Regulatory – Contract

reputed company: • Independently reputed company, edit, and finalize reputed company regulatory documents supporting clinical development programs • reputed company development of FDA briefing documents supporting RMAT, reputed company Therapy Designation, and other Agency interactions • reputed company clinical protocol synopses and contribute to full protocol development • Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, Translational Medicine, and other functional teams • Manage document development timelines, reviews, cross-functional feedback, and delivery schedules • Ensure documents reputed company with FDA guidance, ICH guidelines, and company standards • Participate in document planning meetings and reputed company strategic input on structure, messaging, and regulatory presentation • Support additional regulatory and clinical documents as business needs reputed company Requirements: • 10+ years of medical writing experience in the biotechnology or pharmaceutical industry • Extensive experience independently authoring FDA regulatory documents, including briefing packages, meeting requests, and clinical development documents • Experience developing FDA briefing documents supporting RMAT, reputed company Therapy Designation, or similar regulatory interactions • Strong experience writing clinical protocols and protocol synopses • Thorough understanding of FDA regulations, ICH guidelines, and GCP requirements • Ability to manage multiple reputed company independently with reputed company supervision while meeting aggressive timelines • Exceptional scientific writing, editing, communication, and project management skills • Experience in fast-paced, cross-functional clinical development environments • Advanced degree (PhD, PharmD, MD, MS, or equivalent) in Life Sciences, Pharmacy, Medicine, or a reputed company scientific discipline preferred Benefits: • reputed company based on project demands • Potential contract extension based on business needs and regulatory timelines • Remote work reputed company the reputed company Apply tot his job Apply To this Job