Regulatory Medical Writer Specialist

1 day ago


London, Greater London, United Kingdom BioMarin Pharmaceutical Inc. Full time
About the Role

We are seeking a highly skilled Regulatory Medical Writer Specialist to lead our clinical development programs. As a key member of our team, you will be responsible for overseeing medical writing staff and ensuring timely delivery of high-quality documents.

Responsibilities
  • Oversight of Medical Writing staff to ensure efficient document production and timely completion of projects.
  • Collaboration with the Head of Medical Writing to establish and maintain project timelines and resource allocation.
  • Authoring and editing of clinical study reports, protocols, informed consent forms, and other critical documents supporting regulatory submissions.
  • Drafting and editing of investigator's brochures, periodic safety reports, and briefing books for regulatory agencies.
  • Management of cross-functional team meetings to discuss project progress and address challenges.
  • Peer review and editing support for other regulatory documents, including statistical analysis plans and CRFs.
  • Adherence to departmental procedures, technical standards, and industry guidelines throughout all aspects of work.
Requirements

To succeed in this role, you will need:

  • A minimum of 8 years of experience as a medical writer in the pharmaceutical industry.
  • Prior administrative and/or functional management experience in a clinical development setting is preferred but not required.
  • Demonstrated leadership abilities, planning skills, and experience with delegating tasks and overseeing projects.
  • An advanced understanding of the drug development process, biostatistical concepts, and clinical research principles.
  • Excellent writing, reviewing, and editing skills, with the ability to interpret complex scientific data and translate it into clear, concise text.
  • Proficiency in Microsoft Office, Adobe Acrobat, and document management software such as SharePoint or Veeva.
What We Offer

BioMarin Pharmaceutical Inc. offers a competitive salary and benefits package, estimated at $120,000 - $150,000 per annum, depending on location and experience.

We strive to create a collaborative and dynamic work environment that fosters growth, innovation, and excellence. If you are a motivated and experienced medical writer looking for a challenging opportunity, please apply for this position today.



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