Job Title:
LMS Affiliate Medical Writer
Must Have Technical/Functional Skills
- Awareness of Regulatory guidelines (PhrMA, IFPMA, USFDA-OPDP, MHRA, EMA etc) for
Product promotion, Advertising Standards Council guidelines, Sunshine act, Prescription
Drug Marketing act, Anti Kick-back laws Plagiarism and Copyright laws
- A firm understanding of the regulatory landscape of the US
Roles & Responsibilities
• Perform exhaustive Medical and Regulatory review of content respect to ensure Medical and Regulatory
accuracy, consistency with references, sequencing and accuracy of bibliography references) and
ensure the scientific information in branded or promotional content is current, valid and adheres to
the respective country's pharma regulations
• Focused Review of content, detecting & highlighting of branded or promotional content
• Sharing content review status updates with Project Lead on daily and weekly basis
• To Check the Scientific accuracy and correctness of content to ensure whether content is adequately
supported by evidence, depicted tables/graphs and artwork accurately represent the data and there
are no contradictory messages in the body of the content
• Ensure the correct citations are accurately used as per company referencing style and conventions
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