Job Details

A company is looking for a Senior Director, Medical & Regulatory Writing.Key ResponsibilitiesProvide leadership, strategy, and oversight of the Medical & Regulatory Writing teamServe as a subject matter expert in preparing clinical regulatory documents throughout all phases of clinical researchCollaborate with cross-functional teams to ensure timely delivery of high-quality documents while adhering to regulatory standardsRequired Qualifications and EducationBachelor's, Master's, or PhD Degree in a scientific, medical, or clinical discipline is required; Master's or PhD preferred12+ years of relevant industry experience as a medical writer in a pharmaceutical, biotech, or CRO environmentExperience authoring clinical study reports, protocols, and Investigator's Brochures; regulatory submission experience is a plusStrong understanding of federal regulations, Good Clinical Practices, and ICH guidelinesProficiency in MS Word and familiarity with document formatting tools and EDMS