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Senior Principal Regulatory Medical Writer – Oncology Preferred
Syneos HealthRegulatory Medical Writer crafting submission documents for global regulatory agencies. Joining Syneos Health's Clinical Solutions team to advance drug development processes.
Posted 7/17/2026full-timeRemote • North Carolina • 🇺🇸 United StatesSenior💰 $95,000 - $210,900 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in medical writing for regulatory submissions, with a strong understanding of ICH guidelines and eCTD processes. Proven ability to manage projects effectively while collaborating with cross-functional teams.
Highest-signal resume keywords
Medical Writing ExperienceRegulatory SubmissionsICH Guidelines KnowledgeECTD Submission ExperienceProject Management Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Medical WritingRegulatory Document DevelopmentProject ManagementTimeline ManagementCross-Functional Collaboration
Soft Skills
Communication SkillsTeam Collaboration
Industry Keywords
Regulatory AgenciesGlobal GuidelinesECTD
About the role
Key responsibilities & impact- Develop regulatory documents for submission to regulatory agencies globally
- Manage medical writing projects, including timelines and communication
- Participate in cross-functional meetings to provide input regarding deliverables
- Review other documents associated with assigned projects as appropriate
Requirements
What you’ll need- Experience with medical writing for submission to regulatory agencies globally
- Strong understanding of ICH and other global guidelines
- eCTD submission experience preferred
- Ability to manage medical writing projects including timelines and communication
- Cross-functional team collaboration skills
Benefits
Comp & perks- 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
- Company car or car allowance