Regulatory Medical Writer Specialist
1 day ago
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.
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.
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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