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Senior Medical Writing Manager
2 months ago
Meet is collaborating with an innovative biotechnology firm committed to developing groundbreaking therapies that fulfill critical healthcare needs. They are in search of a talented and seasoned professional for the role of Associate Director or Director of Medical Writing to spearhead their Medical Writing division. In this pivotal position, you will be instrumental in directing and supervising the development of clinical and regulatory documentation vital for progressing their therapeutic pipeline.
Core Responsibilities:
- Offer strategic direction and managerial oversight to the Medical Writing team.
- Oversee the planning, drafting, and completion of various clinical and regulatory documents, which include Clinical Study Reports (CSRs), Investigator's Brochures (IBs), study protocols, safety reports, and New Drug Applications (NDAs).
- Guarantee adherence to industry standards, regulatory mandates, and internal protocols for all documents produced by the team.
- Work closely with interdisciplinary teams, such as Clinical Development, Regulatory Affairs, Pharmacovigilance, and Quality Assurance, to facilitate regulatory submissions and address inquiries from regulatory bodies.
- Guide and cultivate the talent within the Medical Writing team, promoting a culture of excellence, collaboration, and ongoing professional development.
- Focus areas include oncology, metabolism, psychiatry, neurology, and addiction.
Required Qualifications:
- PhD, PharmD, or MD in a relevant scientific field.
- A minimum of 10 years of experience in medical writing within the biotechnology or pharmaceutical sector, emphasizing clinical and regulatory documentation.
- Demonstrated proficiency in preparing significant regulatory submissions (e.g., NDAs, BLAs) and associated documents.
- Comprehensive knowledge of ICH guidelines, GCP, and other pertinent regulations and standards.
- Exceptional leadership capabilities with experience in managing and nurturing a team of medical writers.
- Willingness to work in a hybrid capacity.
Further details regarding the full job description and company information will be provided upon application.
