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