Principal Medical Writer (Regulatory Medical Writing docs)

Syneos Health is seeking a Principal Medical Writer with 5+ years of regulatory medical writing experience. As a Principal Medical Writer, you will lead the clear and accurate completion of complex medical writing deliverables, ensuring scientific information is presented clearly and accurately.

Responsibilities:

• Lead the development of regulatory medical writing documents, including protocols, protocol amendments, CSRs, narratives, PSURs, DSURs, ICFs, and IBs
• Manage medical writing activities associated with individual studies, defining document strategy and coordinating medical writing activities within and across departments
• Complete a variety of documents, including clinical study protocols, clinical study reports, patient narratives, and periodic safety update reports
• 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
• 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
• Aware of budget specifications for assigned projects and communicate status and changes to medical writing leadership

Benefits:

• Career development and progression opportunities
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition and total rewards program
• Inclusive culture