Senior Medical Writer for Regulatory Documents
Amaris
Enhance your career as a Senior Medical Writer with expertise in regulatory documents at Syneos Health. Focus on high-stakes clinical documents like protocols, reports, and submissions across late-phase studies. In this senior role, you will manage comprehensive medical writing activities with minimal supervision. You'll tackle a variety of essential documents, ensuring clarity, accuracy, and adherence to regulatory standards including ICH E3 guidelines. Your technical writing skills will be crucial in mentoring less experienced writers and collaborating with peers across various departments. Key Responsibilities:
- Lead completion of medical writing deliverables
- Coordinate document reviews for scientific clarity
- Author protocols, reports, and informed consents
- Manage communications with clients and stakeholders
- Provide training and mentorship to junior writers
- Senior-level experience in late-phase writing
- Proficient in NDA, IND, and CSR writing
- Strong regulatory knowledge affecting medical writing
- Ability to manage projects within budget
- Experience in authoring clinical documents
Vacancy posted 2 hours ago
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