Senior Medical Writer - Regulatory Documents - CSR /Protocol - Late Phase

Syneos Health • USA-AR-Remote, OH

1d • $80,600 - $145,000

About The Position

Syneos Health is a leading life sciences services organization that partners with innovators across the drug development and commercialization continuum. The Clinical Solutions team members act with a drug development mindset, applying their expertise to understand customer needs and shape solutions. This role involves leading the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately. The position requires managing medical writing activities for individual studies and coordinating across departments with minimal supervision. The company is committed to developing its people through career development, training, and a supportive culture, emphasizing inclusivity and a purpose-driven approach to shaping the future of healthcare.

Requirements

• Senior Medical Writer - Regulatory Documents - CSR /Protocol - Late Phase
• Experience in leading the clear and accurate completion of medical writing deliverables.
• Experience in managing medical writing activities associated with individual studies.
• Experience in coordinating medical writing activities within and across departments with minimal supervision.
• Experience in resolving comments from the client.
• Experience in completing documents such as 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, and abstracts, posters, and presentations for scientific meetings.
• Adherence to established regulatory standards, including ICH E3 guidelines.
• Adherence to company standard operating procedures, client standards, and company and/or client approved-templates, authorship requirements, and style and formatting guides.
• Experience in coordinating quality and editorial reviews.
• Experience in managing source documentation appropriately.
• Experience in leading team document reviews.
• Experience in acting as a peer reviewer for internal teams.
• Experience in reviewing statistical analysis plans and table/figure/listing specifications.
• Experience in interacting and building good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs.
• Experience in performing online clinical literature searches and complying with copyright requirements.
• Experience in identifying and proposing solutions to resolve issues.
• Experience in providing technical support, training, and consultation to department and other company staff.
• Experience in mentoring and leading less experienced medical writers on complex projects.
• Development of deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing.
• Awareness of budget specifications for assigned projects and working within budgeted hours.
• Completion of required administrative tasks within specified timeframes.

Nice To Haves

• Minimal travel may be required (less than 25%).

Responsibilities

• 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.
• Leads the resolution of comments from the client.
• 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.
• Completes required administrative tasks within the specified timeframes.
• Performs other work-related duties as assigned.

Benefits

• Company car or car allowance
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed