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Principal Medical Writer

🔥 4 minutes ago

🇺🇸 United States – Remote

đź’µ $95k - $175.7k / year

⏰ Full Time

đź”´ Lead

🏥📝 Medical Writer

🦅 H1B Visa Sponsor

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Logo of Syneos Health

Syneos Health

10,000+ employees

🏥 Healthcare

đź’Ľ 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.

đź“‹ Description

• Lead clear and accurate completion of complex medical writing deliverables • Manage medical writing activities for individual studies, define document strategy, and coordinate activities across departments • Complete clinical and regulatory documents, manuscripts, abstracts, posters, and presentations • Advise clients and study teams on data presentation and production strategies • Lead team document reviews and coordinate quality and editorial reviews • Serve as an expert peer reviewer for internal teams • Review statistical analysis plans and table, figure, and listing specifications • Build relationships with clients and cross-functional teams in data management, biostatistics, regulatory affairs, and medical affairs • Perform online clinical literature searches and comply with copyright requirements • Identify solutions, serve as a technical subject matter expert, and contribute to internal materials and process improvements • Mentor and lead less experienced medical writers • Develop expertise in industry topics and regulatory requirements and engage with industry groups • Monitor project budgets, contribute to bid projections, and communicate status and timeline changes • Represent medical writing on clinical study teams, at conferences, meetings, and client presentations • Complete administrative tasks and other assigned duties

🎯 Requirements

• Advanced degree in a scientific discipline required (MS, PhD, PharmD, MD, or equivalent) • PhD or PharmD strongly preferred • Minimum 5 years of relevant experience within the pharmaceutical, biotechnology, medical communications, or consulting industries • Demonstrated experience leading publication planning, publication strategy, and publication execution programs • Proven track record developing and executing integrated publication plans across multiple studies and assets • Strong hands-on scientific writing and content development experience, including manuscripts, congress abstracts, posters, and presentations • Experience utilizing AI tools and technologies to support publication development • Preferred location: U.S. East Coast • Ability to adhere to ICH E3 guidelines, company standard operating procedures, client standards, approved templates, authorship requirements, and style and formatting guides • Minimal travel may be required (less than 25%)

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • 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

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