Senior Medical Writer – Regulatory Focus
Syneos Health
full-time
Posted on:
Location Type: Remote
Location: United States
Visit company websiteExplore more
Salary
💰 $80,600 - $145,000 per year
Job Level
About the role
- 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 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.
- Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format.
Requirements
- Minimum of 5 years of lead regulatory writing experience
- Lead writing experience must have Experience with Phase 2 and 3.
- Lead writer experience with protocols, submissions, clinical Summary of Safety (CTD) Modules 2.7.3 and 2.7.4, CSRs (Clinical Study Reports), IBs (Investigator Brochure), Patient Narratives, Safety Aggregate Reports (plus), Briefing books, ISE and ISS (Integrated Summary Efficacy and Integrated Summary Safety).
- Strong project management skills
- Strong client experience
- Time management skills a must
- Process experience is a huge plus
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
medical writingregulatory writingclinical study protocolsclinical study reportsIND submissionsNDA submissionseCTD submissionsCTD Modules 2.7.3CTD Modules 2.7.4safety aggregate reports
Soft Skills
project managementclient experiencetime managementcoordinationpeer reviewattention to detailcommunicationorganizational skillsleadershipeditorial review