Principal Medical Writer – Regulatory Submission Documents

November 26

🌵 Arizona – Remote

Although this job is listed in Arizona, this company may be open to hiring remote in other states.

🦞 Maine – Remote

Although this job is listed in Maine, this company may be open to hiring remote in other states.

+3 more states

🌵 Arizona – Remote 🦞 Maine – Remote 🏈 Ohio – Remote 🔔 Pennsylvania – Remote ⚓ Rhode Island – Remote

💵 $80.6k - $145k / year

⏰ Full Time

🔴 Lead

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Syneos Health

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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.

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately • Manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision • Complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, 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 • Adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides • Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately • Act as a peer reviewer for the internal team to ensure document scientific content, clarity, overall consistency, and proper format • Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency, providing feedback to further define statistical output required and document needs • Interact and build good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables • Perform online clinical literature searches and comply with copyright requirements • Identify and propose solutions to resolve issues, providing technical support, training, and consultation to department and other company staff • Mentor and lead less experienced medical writers on complex projects • Develop deep expertise on key topics in the industry and regulatory requirements • Work within budget specifications for assigned projects

🎯 Requirements

• Bachelor's degree in a relevant discipline with relevant writing experience; graduate degree preferred • 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

• Health benefits to include Medical, Dental and Vision • Company match 401k • Eligibility to participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • Flexible paid time off (PTO) and sick time