Associate Director of Clinical Medical Writing
4 weeks ago
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.
- 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.
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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London, Greater London, United Kingdom newscientist - Jobboard Full timeJob Title: Associate Director of Clinical Medical WritingWe are seeking an experienced Associate Director of Clinical Medical Writing to join our team at BioMarin. 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, investigator brochures,...
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