Associate Manager, Clinical Claims
R
RoHealthcare
New York, NY or RemoteFull-TimeManager
Salary not disclosed
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Job Details
- Experience
- 3 - 5 years of experience in claims substantiation, medical-legal-regulatory (MLR) review, advertising and promotion regulatory affairs, clinical research, or a related field
Requirements
- Have 3–5 years of experience in claims substantiation, MLR review, advertising and promotion regulatory affairs, clinical research, or a related field.
- Critically appraise clinical data, including study design, sample size, endpoints, and statistical versus clinical significance.
- Have working knowledge of FDA and FTC advertising and labeling standards, including the distinction between structure/function and disease claims.
- Have experience partnering with Marketing and Legal in a review or approval process.
- Communicate clearly in writing and verbally, translating technical findings into practical guidance for non-scientific audiences.
- Hold a bachelor’s degree in a scientific or health-related field; an advanced degree is a plus.
- Consulting experience in regulatory, advertising compliance, or life sciences advisory is a bonus.
- Experience with NAD challenges or regulatory inquiries is a bonus.
- Experience building a claims review function from the ground up is a bonus.
Responsibilities
- Review advertising, website content, product pages, packaging, social media, and sales materials for accurate, substantiated, and compliant clinical and performance claims.
- Evaluate clinical studies, published literature, and consumer research to determine whether evidence supports each claim.
- Partner with Marketing, Legal, Regulatory, Clinical, and Product teams on claim wording, risk levels, and additional substantiation needs.
- Offer workable alternatives and solutions to support defensible marketing.
- Build and maintain a claims library and evidence database documenting approved claims and supporting data.
- Establish and refine claims review processes, templates, and approval workflows.
- Audit high-visibility and high-risk claims in market and propose a prioritized roadmap for process improvements and claims library buildout.
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