Senior Medical Writer, Publications

🕒 September 23

🇺🇸 United States – 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 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 scientific meeting presentations • Adhere to regulatory standards, 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 act as an internal peer reviewer • Review statistical analysis plans and table/figure/listing specifications • Collaborate with clients and colleagues in data management, biostatistics, regulatory affairs, and medical affairs • Perform online clinical literature searches • 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 administrative tasks and other assigned duties • Travel minimally, if required

🎯 Requirements

• Experience and deep expertise in medical writing and clinical research documentation • Ability to lead medical writing deliverables with minimal supervision • Knowledge of ICH E3 guidelines, regulatory standards, SOPs, client standards, templates, authorship requirements, and style and formatting guides • Ability to coordinate quality and editorial reviews • Ability to review statistical analysis plans and table/figure/listing specifications • Ability to perform online clinical literature searches and comply with copyright requirements • Ability to identify and resolve issues and provide technical support, training, and consultation • Ability to mentor and lead less experienced medical writers • Deep expertise in relevant industry topics and regulatory requirements and guidelines • 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 401(k) • 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