Senior Medical Writer – Regulatory Documents, CSR, Protocols, IB

🔥 23 hours ago

🇺🇸 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 the clear and accurate completion of medical writing deliverables • Manage medical writing activities for individual studies and coordinate across departments with minimal supervision • 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 regulatory standards, company SOPs, client standards, approved templates, authorship requirements, and style guides • Coordinate quality and editorial reviews and manage source documentation • Lead team document reviews and act as a peer reviewer • Review statistical analysis plans and table/figure/listing specifications • Build working relationships with clients and cross-functional teams in data management, biostatistics, regulatory affairs, and medical affairs • Perform online clinical literature searches • Identify and propose solutions to issues, escalating 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 • Develop expertise in industry topics and regulatory requirements • Monitor assigned project budgets and communicate status and changes to medical writing leadership • Complete administrative tasks and other assigned duties

🎯 Requirements

• Experience and deep expertise in medical writing and drug development • Ability to complete regulatory medical writing deliverables clearly and accurately • Knowledge of ICH E3 guidelines and regulatory standards • Ability to follow company SOPs, client standards, approved 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 provide technical support, training, and consultation • Ability to mentor and lead less experienced medical writers on complex projects • 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 • 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 • Reasonable accommodations, when appropriate