Global Regulatory Compliance Specialist

4 days ago


Pune, Maharashtra, India EVERSANA Full time
Job Title: Global Regulatory Compliance Specialist

Overview:

We are seeking a highly skilled Global Regulatory Compliance Specialist to join our team at EVERSANA. This individual will be responsible for managing the Medical, Legal and Regulatory (MLR) review process for our clients, ensuring that all advertising, promotional, and non-promotional content is accurate, compliant, and ready for publication.

About Us:

EVERSANA is a global company dedicated to creating a healthier world. With over 7,000 employees worldwide, we offer next-generation commercialization services to the life sciences industry. Our team is passionate about improving patient lives and driving innovation in healthcare.

The Role:

As a Global Regulatory Compliance Specialist, you will be responsible for:

  • Managing the end-to-end MLR process for our clients
  • Scheduling, setting agendas, and leading Review Committee meetings
  • Add live discussion notes for comments discussed in Veeva Vault
  • Scribing meeting minutes, circulating draft meeting minutes for Committee approval, and finalizing and filing approved minutes
  • Ensuring all covered communications are properly vetted through the review process utilizing the online review system (e.g., Veeva Vault PromoMats and Vault MedComms)
  • Cascading and enforcing any new policies and guidelines related to review of materials
  • Verifying that materials are assigned to the appropriate review path
  • Rejecting incomplete submissions and materials that are not review-ready
  • Facilitating/documenting discussion in live meetings
  • QCing Final Document vs. Approved Document
  • Supporting FDA 2253 submissions with MLR Regulatory Reviewer/Partner

Requirements:

To be successful in this role, you will need:

  • A degree in a Life Sciences/Biomedical field
  • Excellent communication skills, both written and verbal
  • At least 2 years of experience in a healthcare agency or pharmaceutical company
  • Experience with Veeva Vault PromoMats/MedComms
  • Scientific writing/reviewing/MLR experience
  • Project management skills
  • Time management skills
  • Meeting management skills
  • Excellent customer service skills
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, etc.)

Salary:

$80,000 - $110,000 per year, depending on experience.

Benefits:

We offer a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, paid time off, and professional development opportunities.



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