Senior Director, Medical Writing

MBX Biosciences • Burlington, MA

4d • Hybrid

About The Position

MBX Biosciences is seeking an experienced and dynamic Senior Director of Medical Writing to establish and lead our Medical Writing department. This full-time leadership role will be instrumental in building a high-performing team and developing robust processes to support clinical and regulatory documentation across the organization. The successful candidate will be responsible for overseeing the creation of high-quality clinical and regulatory documents, ensuring alignment with industry standards and global regulatory requirements. This role requires exceptional leadership, deep expertise in medical writing, and a collaborative mindset to work effectively across cross-functional teams, including Clinical Development, Regulatory Affairs, Quality, and Program Management. This individual will report directly to the Senior Vice President of Regulatory & Quality and will play a key role in shaping the strategic direction of medical writing within the company.

Requirements

• Advanced degree in life sciences, medical writing, or a related field (PhD, MD, or equivalent preferred).
• 15+ years of medical writing experience in the biotechnology or pharmaceutical industry.
• Proven track record of leading and managing a team of medical writers.
• Extensive knowledge of regulatory requirements and guidelines (e.g., ICH, FDA, EMA).
• Excellent written and verbal communication skills, with the ability to convey complex scientific information clearly and concisely.
• Excellent problem-solving skills, strategic thinking, and ability to work in a fast-paced, collaborative environment.
• Outstanding scientific leadership and collaboration skills.
• Outstanding interpersonal skills, self-awareness, and ability to manage team dynamics.

Responsibilities

• Lead and manage the Medical Writing team (including internal and external writers), providing guidance, mentorship, and professional development opportunities.
• Oversee the preparation, review, and submission of clinical and regulatory documents, including clinical study reports, protocols, investigator brochures, and regulatory submissions.
• Ensure all documents are accurate, scientifically sound, and compliant with regulatory guidelines and company standards.
• Collaborate with clinical, regulatory, and scientific teams to gather and interpret data, ensuring clear and effective communication of complex scientific information.
• Develop and implement medical writing processes, templates, and best practices to enhance efficiency and quality.
• Stay current with industry trends, regulatory requirements, and best practices in medical writing.
• Represent the Medical Writing function in cross-functional meetings and contribute to strategic planning and decision-making.
• Manage timelines and resources to ensure timely completion of projects.
• Other responsibilities as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree