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Director Of Medical Writing

Global Biotech

Apply before: June 21, 2024
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  • Date posted
    May 22, 2024
  • Location
    Onsite
  • Apply before
    June 21, 2024
  • Career Level
    Manager

Job Description

We are currently seeking a highly experienced and motivated individual to join our Global Biotech as the Director of Medical Writing. As the Director, you will be responsible for leading a team of medical writers and overseeing the development of high-quality scientific and regulatory documents. Key responsibilities include: Managing and mentoring a team of medical writers, Providing guidance and expertise on the development of various documents including clinical study protocols, clinical study reports, investigator’s brochures, and regulatory submissions, Ensuring compliance with relevant regulations and guidelines, Collaborating with cross-functional teams including regulatory affairs, clinical operations, and biostatistics, Overseeing the review, organization, and interpretation of clinical trial data, Contributing to the development of templates, processes, and standard operating procedures. The ideal candidate will have a strong background in medical writing, with a focus on regulatory documents, and proven experience in managing a team. Requirements: Advanced degree in life sciences or related field (PhD, MD, or equivalent), Minimum of 10 years of experience in medical writing, with a focus on regulatory documents, Experience in managing a team of medical writers, Strong knowledge of regulatory guidelines (ICH, FDA, EMA), Excellent writing and editing skills with attention to detail, Proficiency in using relevant software and tools (MS Office, Adobe Acrobat), Ability to effectively communicate and collaborate with cross-functional teams, Strong organizational and leadership skills. If you are a highly motivated and experienced medical writer looking for a challenging leadership role, we encourage you to apply.