Associate Director, Medical Writing

Role: Associate Director of Medical Writing responsible for authoring and overseeing clinical, regulatory, medical, and safety documentation across drug development stages. Objectives include ensuring timely, accurate, and compliant global document delivery to support clinical programs for rare neuroendocrine diseases. Core responsibilities encompass leading document development strategies, coordinating cross-functional teams, reviewing materials for regulatory submissions, and enhancing medical writing processes and standards. Qualifications include a Bachelor's degree (advanced degree preferred), at least 8 years of pharmaceutical/biotech medical writing experience, with expertise in clinical trial documentation, regulatory submissions, and pharmacovigilance. Skills required include superior writing, editing, project management, and data interpretation, along with proficiency in Microsoft Word, Adobe, and document management systems; familiarity with AI tools is advantageous. The role demands a strategic mindset and adaptability to fast-evolving priorities in a hybrid Boston-based setting, with some travel expected. High-value specifics involve a focus on rare neuroendocrine diseases, clinical development phases, and global regulatory compliance, emphasizing collaboration with cross-disciplinary teams to advance innovative therapies for unmet medical needs.