Medical Writer, Clinical Documentation

Role: Medical Writer specializing in clinical regulatory documentation, supporting clinical development through high-quality, compliant medical writing for regulatory submissions. Responsibilities: authoring clinical protocols, CSRs, IBs, and modules for INDs, NDAs, and other filings; collaborating with clinical, regulatory, nonclinical, and CMC teams; ensuring documents meet global regulatory standards (FDA, EMA, ICH); reviewing and revising documents based on feedback; maintaining high standards of quality, accuracy, and scientific rigor; supporting documentation across all clinical phases and management of multiple projects within deadlines; staying current with scientific literature and regulatory guidance. Qualifications: 5-8 years of medical writing experience in pharma, biotech, or clinical research, with preference for oncology backgrounds; Bachelor’s degree in life sciences (Master’s or Ph.D. preferred); proficiency in regulatory requirements and clinical trial processes; experience with writing for regulatory submissions and familiarity with tools like Veeva Vault and standardized templates. HighValue: oncology therapeutic area, clinical trial documentation, global regulatory compliance, IND/NDA/MAA filings, cross-functional collaboration. WorkSetup: primarily office-based, willing to work in team-based environment, with the ability to work long hours if needed.