Senior Medical Writer – Clinical Document Writing

🔥 12 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 clear and accurate completion of medical writing deliverables • Manage medical writing activities for individual studies with minimal supervision • Coordinate medical writing activities within and across departments • Lead resolution of client comments • Complete clinical study protocols and 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 • Adhere to ICH E3 guidelines, company SOPs, 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 • Build working relationships 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, standard practices, 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

• Clinical document writing experience with protocols, clinical study reports (CSRs), and investigator brochures (IBs) • Ability to complete medical writing deliverables clearly and accurately • Experience managing medical writing activities associated with individual studies • Knowledge of ICH E3 guidelines and regulatory standards • Knowledge of company SOPs, client standards, templates, authorship requirements, and style and formatting guides • Experience coordinating quality and editorial reviews • Ability to review statistical analysis plans and table/figure/listing specifications • Experience performing online clinical literature searches and complying with copyright requirements • Ability to provide technical support, training, and consultation • Ability to mentor and lead less experienced medical writers on complex projects • Deep expertise in industry topics and regulatory requirements and guidelines affecting medical writing • Ability to work within budgeted hours and communicate status and changes • Minimal travel may be required (less than 25%) • 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 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) and sick time