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Senior Medical Writing Leader

2 months ago


California, United States Meet Full time

Meet is collaborating with an innovative biotechnology firm committed to developing groundbreaking therapies that fulfill critical medical demands. They are in search of a proficient and seasoned Associate Director or Director of Medical Writing to spearhead their Medical Writing division. In this pivotal role, you will be instrumental in directing and supervising the development of clinical and regulatory documentation vital for progressing their therapeutic pipeline.

Key Responsibilities:

  • Offer strategic direction and managerial oversight to the Medical Writing team.
  • Oversee the planning, drafting, and completion of a diverse array of 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 collaboratively with cross-functional teams, such as Clinical Development, Regulatory Affairs, Pharmacovigilance, and Quality Assurance, to facilitate regulatory submissions and address inquiries from regulatory bodies.
  • Guide and nurture team members within the Medical Writing department, promoting a culture of excellence, collaboration, and ongoing education.
  • Focus areas include oncology, metabolism, psychiatry, neurology, and addiction.

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 sectors, emphasizing clinical and regulatory documentation.
  • Demonstrated proficiency in preparing significant regulatory submissions (e.g., NDAs, BLAs) and accompanying documents.
  • Comprehensive knowledge of ICH guidelines, GCP, and other pertinent regulations and standards.
  • Exceptional leadership capabilities with experience in managing and mentoring 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.