Description
Syneos Health is seeking a Principal Medical Writer - Publications to lead the clear and accurate completion of complex medical writing deliverables. The successful candidate will have at least 6 years of relevant experience in science, technical, or medical writing, with extensive experience working in the biopharmaceutical, device, or contract research organization industry.
Responsibilities:
- Lead the completion of complex medical writing deliverables, ensuring scientific information is presented clearly and accurately
- Manage medical writing activities associated with individual studies, defining document strategy and coordinating medical writing activities within and across departments with minimal supervision
- Lead the resolution of comments from the client
- Complete a variety of documents, including clinical study protocols, clinical study reports, patient narratives, and abstracts
- Adhere to established regulatory standards, including ICH E3 guidelines and company standard operating procedures
- Advise clients and study teams on data presentation and production strategies
- Lead team document reviews and review documents for technical issues
- Serve as expert peer reviewer for internal team
- Review statistical analysis plans and table/figure/listing specifications
- Interact and build good working relationships with clients, department head, and team members
- Perform online clinical literature searches and comply with copyright requirements
- Identify and propose solutions to resolve issues
- Mentor and lead less experienced medical writers on complex documents
- Develop deep expertise on key topics in the industry and regulatory requirements
- Be aware of budget specifications for assigned projects and communicate status and changes to medical writing leadership
Requirements:
- At least 6 years of relevant experience in science, technical, or medical writing
- Extensive experience working in the biopharmaceutical, device, or contract research organization industry
- Advanced understanding of FDA and ICH regulations and guidelines
- Extensive experience writing relevant document types
- Extensive knowledge of English grammar and ability to communicate clearly