Senior Medical Writer – Regulatory Focus

Job not on LinkedIn

🕒 4 days ago

🌐 United States, Canada – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote

💵 $80.6k - $175.7k / year

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

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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 and manage writing activities for individual studies • Coordinate medical writing activities across departments and lead resolution of client comments • Complete clinical, regulatory, safety, submission, and scientific meeting documents, including protocols, CSRs, IBs, patient narratives, aggregate reports, IND/NDA/eCTD submissions, 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, manage source documentation, and lead team document reviews • Act as peer reviewer for scientific content, clarity, consistency, and formatting • Review statistical analysis plans and table/figure/listing specifications and provide feedback on statistical outputs and document needs • Build working relationships with clients and data management, biostatistics, regulatory affairs, and medical affairs teams • Perform clinical literature searches and comply with copyright requirements • Identify and escalate issues and provide technical support, training, and consultation • Mentor and lead less experienced medical writers on complex projects • Develop expertise in industry topics and regulatory requirements affecting medical writing • Monitor assigned project budgets, communicate status and changes, and complete administrative tasks • Perform other assigned duties; minimal travel may be required (less than 25%)

🎯 Requirements

• Minimum of 5 years of lead regulatory writing experience • Lead writing experience with Phase 2 and Phase 3 studies • Lead writer experience with protocols, submissions, CTD Modules 2.7.3 and 2.7.4, CSRs, IBs, patient narratives, briefing books, ISE, and ISS • Experience with Safety Aggregate Reports is a plus • Strong project management skills • Strong client experience • Strong time management skills • Process experience is a plus • Equivalent experience, skills, and/or education may 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 • Company car or car allowance • Medical, dental, and vision health benefits • Company match 401(k) • Eligibility to participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • Flexible paid time off (PTO) • Sick time • Reasonable accommodations when appropriate