Job Description
Job Summary The Associate Director of Medical Writing is responsible for overseeing and delivering high-quality scientific, medical, and regulatory writing across the full product development lifecycle, from clinical protocols through regulatory submissions and post-approval activities. This role provides leadership, strategic direction, and hands-on writing support while managing a team of medical writers and ensuring compliance with regulatory standards and timelines. Responsibilities • Lead and manage clinical, regulatory, and publication writing activities across development programs • Serve as primary author and reviewer for key documents, including protocols, investigator brochures, clinical study reports, and regulatory submission sections • Develop and manage document timelines, resource allocation, and writing plans aligned with clinical development plans • Provide oversight of clinical trial registry updates, including direct data entry when required • Ensure documents comply with applicable regulations and guidelines (ICH, GCP, GLPs) • Implement departmental writing standards, templates, and style guides • Lead document production meetings and cross-functional collaborations • Oversee quality control, editing, and consistency of scientific communications and publications Qualifications • Bachelor’s or Master’s degree in a scientific discipline; PhD preferred • Minimum of 10 years of medical writing experience in pharmaceutical, biotech, or CRO settings • At least 8 years of writing management experience and 10 years of supervisory experience • Demonstrated expertise as a primary author of regulated documents and familiarity with CTD format • Strong understanding of regulatory requirements, clinical research, biostatistics, and data interpretation • Experience managing clinical trial registries (e.g., ClinicalTrials.gov) • Ability to work effectively in a remote environment and collaborate across time zones Apply tot his job