Principal Medical Writer – Publications

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🇬🇧 United Kingdom – 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 medical writing deliverables. • Manages medical writing activities associated with individual studies. • Leads the resolution of comments from the client. • Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports, clinical development plans; IND submissions; integrated summary reports; NDA and eCTD submissions; journal manuscripts; and abstracts, posters, and presentations for scientific meetings. • Adheres to established regulatory standards. • Coordinates quality and editorial reviews. • Ensures source documentation is managed appropriately. • Acts as peer reviewer for internal team. • Reviews statistical analysis plans and table/figure/listing specifications for appropriate content. • Interacts and builds good working relations with clients and peers. • Performs online clinical literature searches. • Identifies and proposes solutions to resolve issues. • Provides technical support, training, and consultation to department and other company staff. • Mentors and leads less experienced medical writers on complex projects. • Develops deep expertise on key topics in the industry.

🎯 Requirements

• 3-5 years of relevant experience in science, technical, or medical writing. • Experience working in the biopharmaceutical, device, or contract research organization industry required. • Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required. • Experience writing relevant document types required. • Extensive knowledge of English grammar and ability to communicate clearly; • Strong familiarity with AMA Manual of Style.

🏖️ 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.