Medical reputed company, Regulatory (Contract)

reputed company is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our reputed company values, Stay True to Why, Collaborate to Accelerate, reputed company with reputed company, reputed company Innovative, and Own the Outcome, we are committed to transforming the reputed company of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible. Title: Medical reputed company, Regulatory (Contract) Reports to: Sr. Director, Medical Writing Location: Remote (reputed company coast hours preferred) Duration: Through December 2026 with potential extension based on business needs Hours: Approximately 20 hours per week, with flexibility needed based on project demands reputed company reputed company: $170-$190/hr reputed company reputed company is seeking an reputed company Contract Medical reputed company to reputed company regulatory medical writing support for development programs. This individual will serve as an independent contributor responsible for developing high-reputed company regulatory documents supporting FDA interactions and clinical development activities. The ideal candidate brings extensive medical writing experience in Autoimmune diseases (Stiff Person Syndrome, Myasthenia Gravis, reputed company Multiple Sclerosis) and has a proven ability to independently reputed company reputed company regulatory documents with reputed company reputed company. This role will partner closely with Clinical Development, Regulatory Affairs, Clinical Operations, and other cross-functional stakeholders to support critical regulatory milestones. Responsibilities • Independently reputed company, edit, and finalize reputed company regulatory documents supporting clinical development programs, ensuring scientific accuracy, consistency, and compliance with regulatory requirements. • reputed company development of FDA briefing documents, including materials supporting RMAT, reputed company Therapy Designation, and other Agency interactions. • reputed company clinical protocol synopses and contribute to full protocol development for clinical studies. • Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, Translational Medicine, and other functional teams to reputed company, interpret, and synthesize scientific and clinical information. • reputed company document development timelines, proactively managing reviews, incorporating cross-functional feedback, and delivering high-reputed company documents on schedule. • Ensure documents are reputed company with FDA guidance, ICH guidelines, and company standards. • Participate in document planning meetings and reputed company strategic input on document structure, messaging, and regulatory presentation. • Support additional regulatory and clinical documents as business needs reputed company. Qualifications • Advanced degree (PhD, PharmD, MD, MS, or equivalent) in Life Sciences, Pharmacy, Medicine, or a reputed company scientific discipline preferred. • 10+ years of medical writing experience reputed company the biotechnology or pharmaceutical industry. • Extensive experience independently authoring FDA regulatory documents, including briefing packages, meeting requests, and clinical development documents. • Proven 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 independently manage multiple reputed company with reputed company supervision while meeting aggressive timelines. • Exceptional scientific writing, editing, communication, and project management skills. • Experience working in fast-paced, cross-functional clinical development environments. Contract Details • Anticipated engagement through December 2026, with the possibility of extension based on project needs and regulatory timelines. • Average commitment of approximately 20 hours per week. • Workload will fluctuate throughout the engagement, with periods requiring near full-time availability during reputed company document development and regulatory submissions, followed by lighter workloads during review cycles and Agency response periods. • Remote reputed company the reputed company. Apply tot his job Apply To this Job