Senior Medical Writer – Regulatory

🕒 April 4

🇺🇸 United States – Remote

💵 $80.6k - $145k / year

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

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

• Leads the clear and accurate completion of medical writing deliverables. • Manages medical writing activities associated with individual studies. • Completes a variety of documents including clinical study protocols and reports. • Adheres to established regulatory standards and guidelines for medical writing projects. • Coordinates quality and editorial reviews and ensures source documentation is managed appropriately. • Acts as a peer reviewer for internal team documents for clarity and format. • Reviews statistical analysis plans for appropriateness and provides feedback. • Interacts and builds relationships with clients and peers in various fields. • Mentors and leads less experienced medical writers on complex projects.

🎯 Requirements

• Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately. • Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. • Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports, clinical development plans; IND submissions; integrated summary reports; NDA and eCTD submissions; journal manuscripts; and abstracts, posters, and presentations for scientific meetings. • Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and/or client approved-templates, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget. • Coordinates quality and editorial reviews. Ensures source documentation is managed appropriately. Leads team document reviews, and reviews documents as needed. • Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format. • Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. Provides feedback to further define statistical output required and document needs. • Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables. • Performs online clinical literature searches and complies with copyright requirements. • Identifies and proposes solutions to resolve issues, escalating as appropriate. Provides technical support, training, and consultation to department and other company staff. • May contribute to development of internal materials and presentations or changes to internal process, standard practices, and capabilities. • Mentors and leads less experienced medical writers on complex projects, as necessary. • Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing. • Aware of budget specifications for assigned projects, working within the budgeted hours and communicating status and changes to medical writing leadership.

🏖️ Benefits

• Health benefits to include Medical, Dental and Vision • 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