Manager, Medical Writer and Quality Control

Role: Manager, Medical Writer and Quality Control supporting regulatory documentation for cell and gene therapy programs in autoimmune diseases. Primary objectives include producing high-quality clinical and regulatory documents aligned with US, EU, and ICH standards to facilitate global filings. Responsibilities encompass authoring and reviewing clinical protocols, investigator brochures, informed consents, and regulatory submissions such as INDs, IMPDs, and other dossiers; managing document timelines; ensuring finalization and publication readiness; collaborating with clinical operations and CROs; and training team members in technical writing. Qualifications: Bachelor's or Master’s in biological sciences with 6+ years’ experience, or Ph.D. with 2+ years’ experience in technical writing; familiarity with regulatory requirements for biologics/pharmaceuticals; experience with global regulatory filings; strong analytical, writing, and communication skills; proficiency in MS Office and Adobe Pro. Preferred: biotech or startup industry experience, prior regulatory submission review experience. High-Value: focus on cell/gene therapies targeting autoimmune diseases, involved in clinical development stages, supporting global regulatory filings, ensuring compliance with GxP and ICH standards. Work Setup: Remote, based in Philadelphia, PA, with no specific travel noted.