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DI

Medical Affairs Consultant

Digital
Posted 3 weeks ago
🌍India, Malaysia, Philippines🏠Remote📁Healthcare/Clinical
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Hire Digital is seeking a Medical Affairs Consultant – Claims Substantiation with an APAC market focus to update and strengthen the internal claims matrix that underpins two of its flagship products, RADIESSE® and ULTHERAPY®. This role will focus on reviewing and appraising clinical evidence, determining which product claims can be safely substantiated, and refining claim language for both healthcare professional (HCP) and consumer-facing use with particular attention to APAC-specific publications and the broader regional evidence base. This is an ideal opportunity for professionals with experience in medical affairs, medico-legal review (MLR), regulatory affairs, or scientific and medical communications who understand how clinical evidence supports promotional claims and can translate complex data into clear, compliant, and commercially useful recommendations. Responsibilities Lead the end-to-end review, update, and expansion of the RADIESSE® and ULTHERAPY® claims matrix, which serves as the internal source of truth for substantiating product claims across marketing, medical education, and HCP engagement. Conduct structured literature reviews to identify relevant new publications not yet captured in the matrix, including APAC-specific clinical studies, real-world evidence, and consensus papers. Critically appraise the quality, strength, and relevance of the clinical evidence behind each claim, applying recognised levels-of-evidence and evidence-grading principles. Determine which claims can be made safely and which require stronger support, clearly distinguishing what is defensible for HCP-facing versus consumer-facing use. Refine claim wording so it is scientifically accurate, clear, and appropriately caveated, including careful handling of superiority and "first/only" style claims. Establish a clear claim hierarchy and identify differentiating or competitive claims that are genuinely supported by the evidence. Validate all references and build a complete, well-organised reference library and source-documentation trail. Identify evidence gaps and recommend priority claims and future evidence-generation opportunities. Ensure the matrix and its recommendations align with medico-legal / regulatory review standards and the client's internal review and approval processes. Present findings and recommendations clearly to medical, marketing, and regulatory stakeholders. Essential Hands-on experience in medical or scientific claims review, medico-legal review (MLR), regulatory affairs, or medical affairs within pharmaceuticals, medical devices, or aesthetics. Strong critical-appraisal skills and confidence working with clinical literature (study design, endpoints, statistics, and evidence grading). Experience conducting literature reviews and validating references. A solid grasp of the principles governing promotional claims, and how substantiation standards differ for HCP versus consumer communications. Excellent scientific writing, with a sharp eye for accuracy and detail. Desirable Familiarity with aesthetics, dermatology, injectables, or energy-based devices. Awareness of APAC regulatory nuances, local codes of practice, and regional evidence.

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