Associate Director of Clinical Medical Writing

4 weeks ago


London, Greater London, United Kingdom BIOMARIN Full time
About the Role

BioMarin is seeking a highly skilled Associate Director of Clinical Medical Writing to join our team. As a key member of our Clinical Medical Writing department, you will be responsible for overseeing the development of high-quality clinical documents, including protocols, clinical study reports, and regulatory submissions.

Key Responsibilities
  • Lead a team of medical writers in the development of clinical documents, ensuring timely and high-quality delivery.
  • Collaborate with cross-functional teams, including clinical operations, regulatory, and development sciences, to ensure alignment and effective communication.
  • Develop and maintain processes and templates to ensure consistency and efficiency in document development.
  • Provide guidance and training to medical writers on regulatory requirements, clinical study conduct, and document development best practices.
  • Manage vendor relationships and oversee the development of documents by external writers.
  • Ensure compliance with regulatory requirements, including FDA and EU guidelines.
Requirements
  • Minimum 10 years of experience as a medical writer in the pharmaceutical industry.
  • At least 3 years of experience in a leadership role, managing a team of medical writers.
  • Advanced understanding of clinical study conduct, biostatistics, and regulatory requirements.
  • Excellent communication and leadership skills, with the ability to motivate and guide a team.
  • Proficiency in Microsoft Office, including Word, Excel, and PowerPoint.
What We Offer

BioMarin offers a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced medical writer looking for a challenging role, please submit your application.



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