Senior Regulatory Submissions Writer

🔥 12 hours ago

🇺🇸 United States – Remote

💵 $70.1k - $145k / year

⏰ Full Time

🟠 Senior

✏️ Content 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 • Coordinate medical writing activities within and across departments • Lead resolution of client comments • Complete clinical study protocols, clinical study reports, patient narratives, investigator brochures, informed consents, plain language summaries, safety reports, IND submissions, NDA and 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 format • 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 propose solutions, escalating issues as appropriate • Provide technical support, training, and consultation • Contribute to internal materials, presentations, processes, standards, and capabilities • Mentor and lead less experienced medical writers • Develop expertise in industry topics and regulatory requirements • Work within budgeted hours and communicate status and changes to medical writing leadership • Complete administrative tasks and other assigned duties

🎯 Requirements

• 3-5 years of relevant experience in regulatory writing • Experience working in the biopharmaceutical, device, or contract research organization industry • Strong understanding of EMA, FDA and ICH regulations, other regulatory guidelines, and/or good publication practices • Experience writing relevant document types • Extensive knowledge of English grammar • Ability to communicate clearly • Strong familiarity with AMA Manual of Style • 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 • Inclusive culture • Company car or car allowance • Medical, Dental and Vision health benefits • Company match 401k • Eligibility to earn commissions/bonus based on company and individual performance • Flexible paid time off (PTO) • Sick time

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