Lead Medical Writer at Precision Medicine
Precision Medicine Group
Elevate your writing career as a Senior Medical Writer with Precision Medicine Group, where you'll craft high-quality clinical documents in a fast-paced environment. Bring your expertise in compliance and document management to the forefront. As a Senior Medical Writer, you'll be key in developing clinical study documents that adhere to regulatory guidelines like ICH and FDA. Your role includes writing, editing, formatting, and performing quality control review to ensure all documents meet company and regulatory standards. Collaborate effectively with internal teams and external clients while executing complex writing assignments with precision. Key Responsibilities:
- Lead the planning and writing of clinical documents
- Manage the document lifecycle from template to final approval
- Author complex content based on clinical study data
- Maintain and develop medical writing processes and SOPs
- Conduct literature-based research to support writing tasks
- BS in a scientific or medical discipline
- 5+ years of experience as a Senior Medical Writer
- Proficiency in Microsoft Office and Adobe Acrobat
- Comprehensive understanding of regulations and eCTD
- Impeccable attention to detail in writing assignments
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