Medical Content and Regulatory Review Coordinator

23 hours ago


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

We are seeking a highly skilled Medical Content and Regulatory Review Coordinator to join our team. The ideal candidate will have a strong background in medical content and regulatory review, with excellent communication and project management skills.

Job Description:
  • Oversee the end-to-end review process for all materials, ensuring compliance with internal and external policies and regulations.
  • Schedule and lead Review Committee meetings, ensuring that all materials undergo proper review in our online system.
  • Add live discussion notes during meetings and ensure that all comments are documented accurately.
  • Draft and finalize meeting minutes for approval, ensuring all records are filed and archived appropriately.
  • Verify that all submitted materials are complete and properly assigned to the correct review path, rejecting incomplete or unreview-ready submissions.
  • Conduct quality checks to compare the final document to the approved version.

The successful candidate will be responsible for managing multiple projects simultaneously, prioritizing tasks effectively, and meeting deadlines. Excellent communication and interpersonal skills are essential for success in this role.

Required Skills and Qualifications:
  • 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, with the ability to communicate effectively in both written and oral forms.
Benefits:
  • This is a full-time position with flexibility in scheduling to accommodate client and management needs.
  • No travel required.
Others:
  • Familiarity with global healthcare compliance laws and regulations is preferred.
  • Previous experience with scientific writing or reviewing in an MLR context is an asset.


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