Senior Medical Writer – Sponsor-dedicated

🔥 2 minutes ago

🌐 United Kingdom, Poland, +2 more countries – Remote

🇬🇧 United Kingdom – Remote 🇵🇱 Poland – Remote 🇪🇸 Spain – Remote 🇷🇸 Serbia – Remote

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

🇬🇧 UK Skilled Worker Visa Sponsor

This company has sponsored UK Skilled Worker visas in the past.

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

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

• Lead clear and accurate completion of medical writing deliverables • Manage medical writing activities for individual studies and coordinate activities across departments • Lead resolution of client comments • Complete clinical study protocols, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, safety reports, clinical development plans, regulatory submissions, journal manuscripts, abstracts, posters, and presentations • Follow ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements, and style guides • Coordinate quality and editorial reviews and manage source documentation • Lead team document reviews and act as a peer reviewer • Review statistical analysis plans and table/figure/listing specifications • Collaborate with clients and data management, biostatistics, regulatory affairs, and medical affairs teams • Perform online clinical literature searches and comply with copyright requirements • Identify and resolve issues, provide technical support and training, and contribute to internal materials and process improvements • Mentor and lead less experienced medical writers on complex projects • Develop expertise in industry topics and regulatory requirements • Work within project budgets and communicate status and changes to medical writing leadership • Complete required administrative tasks and other assigned duties

🎯 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 • Equivalent experience, skills, and/or education will also be considered

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Inclusive culture • Minimal travel may be required (less than 25%)

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