Principal Medical Writer

🔥 58 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

🏥📝 Medical Writer

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Leads the clear and accurate completion of complex medical writing deliverables, ensuring scientific information is presented clearly and accurately. • Manages medical writing activities associated with individual studies, defining document strategy and coordinating medical writing activities within and across departments with minimal supervision. • Leads team document reviews and reviews documents for technical issues. • Coordinates quality and editorial reviews and ensures source documentation is managed appropriately. • Serves as expert peer reviewer for internal team, providing review comments to give maximum clarity of meaning, accuracy, and relevance. • Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.

🎯 Requirements

• Leads the clear and accurate completion of complex medical writing deliverables. • Manages medical writing activities associated with individual studies. • Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; • Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, • Advises clients and study teams on data presentation and production strategies. • Coordinates quality and editorial reviews. • Serves as expert peer reviewer for internal team. • Reviews statistical analysis plans and table/figure/listing specifications. • Interacts and builds good working relationships with clients.

🏖️ Benefits

• We are passionate about developing our people, through career development and progression; • Supportive and engaged line management; • Technical and therapeutic area training; • Peer recognition and total rewards program. • Committed to building an inclusive culture – where you can authentically be yourself.