SlipstreamJobs tracks this role from the company's public career site. Apply directly on the employer's site.
MBX Biosciences is seeking an experienced Senior Director of Medical Writing to establish and lead the Medical Writing department. This full-time leadership role reports directly to the Senior Vice President of Regulatory & Quality and is instrumental in building a high-performing team and developing robust processes to support clinical and regulatory documentation across the organization.
Key responsibilities include leading and managing the Medical Writing team (internal and external writers), providing guidance, mentorship, and professional development. The role oversees preparation, review, and submission of clinical and regulatory documents including clinical study reports, protocols, investigator brochures, and regulatory submissions. The successful candidate will ensure all documents are accurate, scientifically sound, and compliant with regulatory guidelines and company standards.
The director will collaborate with clinical, regulatory, and scientific teams to gather and interpret data, ensuring clear communication of complex scientific information. Additional responsibilities include developing and implementing medical writing processes, templates, and best practices to enhance efficiency and quality; staying current with industry trends and regulatory requirements; representing the Medical Writing function in cross-functional meetings; and managing timelines and resources for timely project completion.
Required qualifications include an advanced degree in life sciences, medical writing, or related field (PhD, MD, or equivalent preferred) and 15+ years of medical writing experience in biotechnology or pharmaceutical industry. The candidate must have a proven track record of leading and managing medical writing teams, extensive knowledge of regulatory requirements and guidelines (ICH, FDA, EMA), and excellent written and verbal communication skills. Outstanding scientific leadership, collaboration skills, problem-solving ability, and interpersonal skills are essential.
The role is hybrid with periodic travel expected for business needs, including attendance at company meetings and functional gatherings.
