Position SummaryMBX 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.
Key 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.
Qualifications - 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.
Travel & In Office Presence You will be expected to travel periodically based on the needs of the business, including attendance at Together Weeks, Together Days, and functional meetings as requested by the team. Employees are expected to work on hybrid schedules, consistent with local office practices and the terms of the companies in office policy as in effect from time to time.
