HealthMinds Consulting Pvt. Ltd,
Website:
healthminds.com
Job details:
Junior Medical Content Reviewer: Promotional Claims
Level: 11 | Experience: 2–4 years | Location: Mumbai
Reports To: Senior Medical Content Reviewer / Medical Affairs Lead
US Shift: 5:30 pm to 3 am IST
Role Summary
Identify promotional claims in pharma content and substantiate them with accurate evidence from scientific literature. Support the MLR review process and implement reviewer feedback, ensuring materials are scientifically accurate, balanced, and compliant. Work under the guidance of senior SMEs while building expertise in evidence appraisal, regulatory guidelines, and MLR workflows.
Key Responsibilities
Claim Identification
- Review promotional content and identify every claim, explicit and implied, including those in headlines, charts, tables, and visuals
- Classify claims by type: efficacy, safety, comparative, mechanistic, quality of life, and market leadership
- Break down compound statements into individual claims that each need substantiation
- Flag unsupported, off-label, or potentially misleading claims for senior review
- Maintain accurate claim logs linking each claim to its supporting evidence
Scientific Substantiation via Literature
- Conduct structured literature searches across PubMed, Embase, Cochrane, and ClinicalTrials.gov to find evidence for each claim
- Identify the correct and most relevant literature, prioritizing primary sources (original clinical trials) over secondary sources (reviews, abstracts)
- Verify that each reference accurately supports the claim, checking that the patient population, dose, indication, endpoint, comparator, and timepoint match exactly
- Extract the precise data point, statistic, or statement from the reference and pinpoint its location (page, table, figure, or section)
- Check that numbers, percentages, and statistical values in the content match the source exactly
- Confirm references are current, published, and from credible peer-reviewed sources
- Flag claims where the evidence is weak, indirect, outdated, or does not fully support the wording
- Prepare substantiation dossiers under senior supervision
Regulatory Compliance
- Use the approved label (SmPC/PI) as the reference for claim boundaries
- Apply working knowledge of FDA OPDP, ABPI, and EFPIA guidelines
- Flag fair balance and off-label concerns
MLR Process & Workflow
- Understand the end-to-end MLR lifecycle and the distinct roles of medical, legal, and regulatory reviewers
- Prepare content for MLR submission with accurate referencing and annotation
- Route and track content in Veeva Vault PromoMats or an equivalent platform, maintaining version control and audit trails
MLR Feedback Implementation
- Interpret reviewer comments accurately, including the intent behind them
- Implement feedback completely and on time, documenting how each comment was addressed
- Update references and annotations when claim wording changes
- Ensure changes do not alter claim meaning, break references, or affect fair balance
- Escalate unclear or conflicting comments to senior reviewers
Qualifications
- Bachelor's in Pharmacy or Life Sciences (mandatory); M.Pharm/MSc preferred
- 2–4 years in medical writing, medical affairs, clinical research, pharmacovigilance, or regulatory affairs
Must-Have Skills
- Ability to identify explicit and implied claims in promotional content
- Hands-on literature search skills across major scientific databases
- Ability to read clinical papers and confirm whether a reference accurately supports a specific claim
- Basic understanding of clinical trial design and evidence hierarchy
- Basic understanding of the MLR process and ability to implement reviewer feedback accurately
- Strong attention to detail and written communication
Good-to-Have
- Hands-on Veeva Vault PromoMats experience
- Exposure to promotional content review
- Therapeutic area experience (oncology, cardiovascular, immunology, neuroscience)
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