Medical Content and Regulatory Affairs Expert

2 days ago


Pune, Maharashtra, India beBeeRegulatory Full time US$ 90,000 - US$ 1,20,000
Job Title: Medical Content and Review Specialist

This is a unique opportunity to join our team as a highly skilled Medical Content and Review Specialist. As a key member of our organization, you will be responsible for overseeing the end-to-end MLR review process for all materials, ensuring compliance with internal and external policies and regulations.

Key Responsibilities:
  • Lead the Review Committee meetings, ensuring that all materials undergo proper review in the online system.
  • Add live discussion notes during meetings and document comments accurately.
  • Draft, circulate, and finalize meeting minutes for approval.
  • Verify that all submitted materials are complete and properly assigned to the correct review path.
  • Conduct quality checks to compare the final document to the approved version.
Additional Responsibilities:
  • Support FDA 2253 submissions in partnership with the MLR Regulatory Reviewer.
  • Assist with the development of project plans and provide administrative support for the medical content team.
  • Support the upload of materials into clients review and approval platforms.
Requirements:
  • Bachelor's degree in a Life Sciences or Biomedical field.
  • At least 2 years of experience in a healthcare agency or pharmaceutical company, with a focus on MLR review processes.
  • Proficiency in Veeva Vault PromoMats/MedComms.
  • Strong project management, time management, and meeting management skills.
  • Excellent customer service skills.
  • Computer proficiency in Microsoft Office Suite.
Preferred Qualifications:
  • Postgraduate degree in Pharmacy, Medicine, or related field.
  • Familiarity with global healthcare compliance laws and regulations.
  • Previous experience with scientific writing or reviewing in an MLR context.


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