Senior Medical Content Reviewer: Promotional Claims SME

Senior Medical Content Reviewer: Promotional Claims SME

Level: 8 | Experience: 7–10+ years | Location: WFH
Reports To: Head of Medical Affairs / Director of Scientific Services

Role Summary
Serve as the subject matter expert for identifying promotional claims and substantiating them with the strongest, most accurate scientific evidence. Independently lead claim review and substantiation, own the MLR workflow for assigned portfolios, resolve complex MLR feedback, and act as the primary scientific interface with client medical and commercial teams. Mentor junior reviewers and set internal review standards.

Key Responsibilities

Claim Identification

• Independently identify all claim types, including those made through visuals, data presentation, omission, or framing
  
• Deconstruct complex headlines and campaign messages into individual substantiable claims
  
• Classify claims by type, risk level, and regulatory sensitivity
  
• Lead claim risk assessments across multi-channel campaigns
  
• Develop claim taxonomies and identification checklists for the team
  

Scientific Substantiation via Literature

• Design and lead systematic literature search strategies (using PICO) across PubMed, Embase, Cochrane, and trial registries
  
• Select the strongest and most appropriate evidence for each claim based on evidence hierarchy, study design, quality, and relevance
  
• Rigorously verify that references accurately and fully support claim wording, including population, indication, dose, endpoint, comparator, timepoint, and statistical significance
  
• Critically appraise RCTs, meta-analyses, systematic reviews, and real-world evidence for bias, heterogeneity, and limitations
  
• Identify misused evidence, such as post-hoc subgroups used for broad claims, surrogate endpoints implying clinical outcomes, or non-inferiority data used for superiority
  
• Assess whether the totality of evidence, including conflicting or unfavorable studies, supports the claim
  
• Adjudicate complex and gray-area substantiation decisions with documented scientific rationale
  
• Recommend compliant claim rewording when evidence only partially supports the original
  
• Advise on evidence generation when gaps exist; set substantiation dossier and referencing standards
  
• QA junior reviewers' literature selection and reference accuracy
  

Regulatory Compliance

• Apply expert knowledge of FDA OPDP, ABPI, EFPIA, and national codes
  
• Identify explicit and implied off-label risks; assess fair balance across text and design
  
• Guide multi-market claim adaptation; track enforcement trends (warning letters, PMCPA rulings)
  

MLR Process Ownership

• Own the end-to-end MLR workflow: submission, review rounds, approval, re-review, expiry, and withdrawal
  
• Ensure content is review-ready, with complete referencing and annotation, to maximize first-pass approval
  
• Manage lifecycle obligations, including label updates and withdrawal of outdated materials
  
• Optimize MLR workflows and SOPs; ensure audit-ready documentation
  

MLR Feedback Management

• Interpret complex feedback and the underlying medical, legal, or regulatory concern
  
• Resolve conflicting feedback between reviewers through structured discussion
  
• Respectfully challenge scientifically unfounded comments with evidence
  
• Lead comment resolution meetings; QA junior feedback implementation
  
• Turn recurring feedback patterns into checklists, training, and process fixes
  

Stakeholder & Team Leadership

• Communicate substantiation decisions clearly to non-scientific stakeholders and offer compliant alternatives
  
• Maintain scientific integrity under commercial pressure
  
• Mentor and train junior reviewers on claim identification, literature search, and evidence appraisal
  
• Support evaluation of AI-assisted claim review tools
  

Qualifications

• Advanced degree (PharmD, PhD, MD/MBBS, or M.Pharm) mandatory
  
• RAC, CMPP, or CMAP certification highly valued
  
• 7–10+ years in medical affairs, regulatory affairs, promotional medical writing, scientific communications, or HEOR
  

Must-Have Skills

• Expert ability to identify all claim types, including implied and visual claims
  
• Advanced literature search and critical appraisal skills
  
• Proven ability to select the right evidence and verify it accurately supports claim wording
  
• Advanced biostatistics literacy (CI, NNT, ARR/RRR, MCID, heterogeneity)
  
• Direct experience leading the MLR process and resolving complex MLR feedback
  
• Expert knowledge of promotional regulations and approved label interpretation
  
• Proficiency in Veeva Vault PromoMats or an equivalent platform
  
• Deep expertise in at least one therapeutic area
  

Good-to-Have

• Experience as a medical reviewer or approver on an MLR committee
  
• Systematic review methodology experience (PRISMA, AMSTAR-2)
  
• Multi-market and multi-client experience
  
• Experience designing MLR workflows or compliance SOPs