Senior Medical Writer & Editorial Lead

Syneos Health/ inVentiv Health Commercial LLC; Nebraska; Remote; USD 90,000 - 120,000; Full time

Benefits offered by this job

Car allowance

Health benefits

401k match

Employee Stock Purchase Plan

Bonus based on performance

Flexible PTO

Job summary

Syneos Health/ inVentiv Health Commercial LLC is seeking a skilled medical writer to lead the creation and review of clinical writing deliverables across studies, ensuring scientific accuracy and timely delivery.

The role involves coordinating with data management, biostatistics, regulatory affairs, and medical affairs, mentoring junior writers, and maintaining compliance with ICH guidelines and internal SOPs. Some travel may be required.

Responsibilities

• Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.
• Completes a variety of documents that may include journal manuscripts, abstracts, posters, and presentations for scientific meetings.
• Adheres to established regulatory standards, including ICH E3 guidelines and SOPs, client standards, and templates, on time and on budget.
• Coordinates quality and editorial reviews; leads team document reviews and reviews documents as needed.
• Acts as peer reviewer for internal team to ensure document content, clarity, and format.
• Interacts with clients and colleagues across data management, biostatistics, regulatory affairs, and medical affairs to produce deliverables.
• Identifies issues and provides solutions; mentors staff; contributes to internal materials and process improvements.
• Mentors and leads less experienced medical writers on complex projects as necessary.
• Develops deep expertise on industry topics and regulatory requirements affecting medical writing.
• Aware of budget specifications and communicates status and changes to leadership.
• Completes required administrative tasks within timeframes.
• Performs other duties; minimal travel may be required (<25%).

Job description

Syneos Health/ inVentiv Health Commercial LLC is seeking a skilled medical writer to lead the creation and review of clinical writing deliverables across studies, ensuring scientific accuracy and timely delivery.

The role involves coordinating with data management, biostatistics, regulatory affairs, and medical affairs, mentoring junior writers, and maintaining compliance with ICH guidelines and internal SOPs. Some travel may be required.