Senior Medical Writer – Regulatory Focus

🔥 15 hours 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 the clear and accurate completion of medical writing deliverables • Manage medical writing activities associated with individual studies and coordinate activities across departments • Lead resolution of client comments • Complete clinical study protocols, protocol amendments, clinical study 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, abstracts, posters, and presentations • Follow ICH E3 guidelines, company standard operating procedures, client standards, approved templates, authorship requirements, and style and formatting guides • Coordinate quality and editorial reviews and manage source documentation • Lead team document reviews and review documents as needed • Act as peer reviewer for internal teams • Review statistical analysis plans and table/figure/listing specifications • Interact with clients and colleagues in data management, biostatistics, regulatory affairs, and medical affairs • Perform online clinical literature searches and comply with copyright requirements • Identify and propose solutions, escalating issues as appropriate • Provide technical support, training, and consultation • Contribute to internal materials, presentations, processes, standard practices, and capabilities • Mentor and lead less experienced medical writers on complex projects • Develop expertise in industry topics and regulatory requirements affecting medical writing • Work within budgeted hours and communicate status and changes to medical writing leadership • Complete required administrative tasks • Perform other assigned work-related 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 • Lead writer experience with submissions • Lead writer experience with clinical Summary of Safety (CTD) Modules 2.7.3 and 2.7.4 • Lead writer experience with CSRs (Clinical Study Reports) • Lead writer experience with IBs (Investigator Brochure) • Lead writer experience with Patient Narratives • Experience with Safety Aggregate Reports is a plus • Lead writer experience with Briefing Books • Lead writer experience with ISE and ISS (Integrated Summary Efficacy and Integrated Summary Safety) • Strong project management skills • Strong client experience • Strong time management skills • Process experience is a plus • 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 workplace culture • Company car or car allowance • Medical, Dental and Vision health benefits • 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) • Sick time • Reasonable accommodations when appropriate