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
• US Shift: 5:30 pm to 3 am IST

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
• 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