Job Title: Director, Medical Writing

Location: Cambridge, MA

About Us: We are a pioneering biotechnology company based in Cambridge, MA, dedicated to the research, development, and commercialization of innovative treatments for central nervous system (CNS) disorders, with a particular focus on Alzheimer’s disease. Our mission is to improve the lives of patients and their families through groundbreaking therapies that address the unmet needs in CNS diseases.

Position Overview: We are seeking a highly skilled and experienced Director of Medical Writing to join our team. The ideal candidate will lead our medical writing efforts, ensuring the highest quality of scientific and regulatory documentation. This role is crucial in supporting our clinical development programs and regulatory submissions for Alzheimer’s disease treatments.

Key Responsibilities:

• Lead and manage the medical writing team, including hiring, training, and performance evaluations.
• Develop and implement medical writing strategies and processes to support clinical development and regulatory submissions.
• Oversee the preparation, review, and approval of high-quality clinical and regulatory documents, including clinical study protocols, investigator brochures, clinical study reports, and regulatory submission documents (INDs, NDAs, MAAs).
• Collaborate with cross-functional teams, including clinical development, regulatory affairs, biostatistics, and clinical operations, to ensure alignment and accuracy of scientific content.
• Ensure compliance with regulatory guidelines, company standards, and best practices in medical writing.
• Stay current with industry trends, regulatory requirements, and advances in Alzheimer's disease research and treatments.
• Provide strategic input and support for regulatory interactions and submissions.
• Manage external medical writing vendors and consultants, ensuring quality and timely delivery of outsourced projects.
• Contribute to the development of publications, abstracts, and presentations for scientific conferences and journals.

Qualifications:

• Advanced degree in life sciences (PhD, PharmD, MD, or equivalent) preferred.
• Minimum of 10 years of medical writing experience in the pharmaceutical or biotechnology industry, with a focus on CNS disorders and Alzheimer’s disease.
• Proven track record of successful regulatory submissions (INDs, NDAs, MAAs) and clinical documentation.
• Strong leadership and team management skills, with the ability to mentor and develop a high-performing medical writing team.
• Excellent written and verbal communication skills, with the ability to convey complex scientific information clearly and concisely.
• Strong understanding of clinical development processes, regulatory requirements, and ICH guidelines.
• Experience working in a fast-paced, collaborative environment with cross-functional teams.
• Attention to detail, strong organizational skills, and the ability to manage multiple projects simultaneously.
• Proficiency with medical writing software and tools.

Why Join Us:

• Opportunity to make a significant impact on the development of innovative treatments for Alzheimer’s disease.
• Collaborative and dynamic work environment.
• Competitive salary and comprehensive benefits package.
• Professional growth and development opportunities.