Get new jobs for this search by email

Senior Director/ Director, Medical Writing Be among the first 25 applicants two weeks ago. Direct message the job poster from Fortvita Biologics. This role serves as an expert Medical Writer responsible for planning, developing, and writing clinical documents to support medical and regulatory activities across the portfolio. The goal is to ensure scientifically robust messages and arguments are conveyed consistently across all documents. Responsibilities Lead the planning and authoring of complex, strategic clinical and regulatory documents and submission packages using expert medical writing skills. Guide a medical writing and project team during planning and authoring stages across various document types and regulatory submissions, including facilitating meetings, managing timelines, coordinating reviews, and driving decision-making. Initiate and lead strategic medical writing initiatives and processes aligned with company priorities. Develop, review, and improve departmental processes, policies, SOPs, training, and work guidance. Own relevant medical writing processes and lead SOP creation/update initiatives. Mentor junior writers and actively contribute to departmental strategy and development. Requirements PhD in life sciences or biological sciences preferred. Experience in the pharmaceutical industry, with oncology and immunology experience highly preferred. Minimum of 10 years' medical or scientific writing experience. Extensive experience writing protocols, clinical study reports, and authoring clinical components in regulatory filings (NDA, BLA, MAA). Deep understanding of regulatory requirements, drug development processes, GCP, and clinical study data reporting. Expertise in document content preparation, style guides, medical dictionaries, and regulatory guidance documents. Ability to work collaboratively and lead cross-functional teams. Strong interpersonal skills and ownership mindset. Hybrid working model. Seniority level Director Employment type Full-time Job function Research and Science Industries Pharmaceutical Manufacturing, Biotechnology Research, Medical Practices #J-18808-Ljbffr