Senior Medical Writer

🔥 20 hours ago

🏰 Missouri – Remote

🏰 Missouri – 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 for individual studies across departments with minimal supervision • 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 • Apply regulatory standards, company SOPs, client standards, approved templates, authorship requirements, and style/formatting guides • Coordinate quality and editorial reviews • 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 • 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 to issues, escalating as appropriate • Provide technical support, training, and consultation • Contribute to internal materials, presentations, processes, standards, and capabilities • Mentor and lead less experienced medical writers on complex projects • Develop expertise in industry topics and regulatory requirements • Monitor project budgets and communicate status and changes to medical writing leadership • Complete required administrative tasks • Perform other assigned work-related duties

🎯 Requirements

• Experience and deep expertise in medical writing and drug development • Ability to lead clear and accurate medical writing deliverables with minimal supervision • Knowledge of regulatory standards, including ICH E3 guidelines • Ability to work with company/client SOPs, standards, templates, authorship requirements, and style/formatting guides • Experience coordinating quality and editorial reviews and managing source documentation • Ability to peer review scientific content for clarity, consistency, and format • Ability to review statistical analysis plans and table/figure/listing specifications • Clinical literature search skills and knowledge of copyright requirements • Ability to provide technical support, training, and consultation • Ability to mentor less experienced medical writers • Knowledge of industry topics and regulatory requirements affecting medical writing • Ability to work within budgeted hours and complete administrative tasks on time • Equivalent experience, skills, and/or education will also be considered • 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 participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • Flexible paid time off (PTO) • Sick time