National Employee Health and Benefits Compliance Consultant
Marsh McLennanAdvise Marsh McLennan Agency clients on U.S. employee health and benefits compliance. Support compliance education, training, research, and client presentations.
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Syneos Health is a fully integrated biopharmaceutical solutions organization that helps clients move therapies from clinical development to commercial delivery. Its teams combine clinical, medical affairs, commercial, technology, and market insights to address changing healthcare needs and support the development and launch of important treatments worldwide.
Country Regulatory Specialist, NAMER Clinical Trial Submissions
Lead country-level regulatory work for clinical trial submissions and approvals at Syneos Health. Coordinate timelines, authorities, ethics committees, and compliance across assigned projects.
United States
North Carolina$67,700 – $115,100 / year
HybridFull-timeMiddleSeniorEnglish RequiredComplianceDescription
- Deliver quality work at country and site level in line with project requirements and local rules.
- Keep current expertise in regulatory affairs and ethics committee processes, requirements, timelines, regulations, laws, and guidance.
- Provide country regulatory expertise for business development and site selection.
- Track country start-up timelines and recommend strategies.
- Forecast submission and approval dates, track milestones, assess delays, recommend mitigation, and escalate risks.
- Prepare and submit applications to central and local ethics committees, regulatory authorities, and hospitals.
- Prepare amendments, periodic and safety notifications, and other required submissions.
- Liaise with regulatory authorities and ethics committees, and coordinate responses to their queries.
- Act as the country regulatory subject matter expert and contact throughout assigned projects.
- File relevant documents in the Trial Master File in accordance with SOPs and customer requirements.
- Maintain country information in regulatory intelligence systems and complete or contribute to Regulatory Impact Assessments.
- Create or assist with training materials on local regulations.
- Help the Syneos Health Procurement team manage ethics committee and IRB vendors.
- Continuously improve quality at country level.
- Follow SOPs and Work Instructions, keep training current, and submit accurate timesheets.
- Track workload, scope, budgeted effort, and project hours, and escalate discrepancies.
Requirements
- A BA or BS is preferred.
- At least 3–4 years of clinical research experience, or an equivalent combination of education and experience.
- Detailed knowledge of clinical trials across Phases I–IV and ICH GCP.
- Detailed knowledge of country-specific clinical trial submissions and local regulations.
- Experience working under applicable GxP standards, such as GVP, GCP, or ISO 14155.
- Strong organizational and problem-solving abilities.
- A record of meeting deadlines while maintaining high quality.
- Strong presentation, documentation, influencing, and spoken and written communication skills.
- A collaborative, team-oriented approach.
- Proficiency with Microsoft Office, web-based systems, voicemail, email, and the internet.
- Ability to manage competing priorities in a fast-paced, changing environment.
- Ability to work independently and collaboratively.
Benefits
- Career development and advancement opportunities.
- Supportive, engaged line management.
- Training in technical and therapeutic areas.
- Peer recognition and a total rewards program.
- An inclusive culture.
- Company car or car allowance.
- Medical, dental, and vision coverage.
- 401(k) with company match.
- Eligibility to participate in the Employee Stock Purchase Plan.
- Eligibility for commissions or bonuses based on company and individual performance.
- Flexible paid time off.
- Sick leave.
- Reasonable accommodations when appropriate.
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