Medical| Legal and Regulatory Reviewer|MLR|

Job Insights :

The Medical, Legal and Regulatory (MLR) review is an essential process in healthcare marketing to make sure advertising, promotional and non-promotional content is accurate, compliant, and ready to be published.

The MLR process must rigorously control and execute review, approval and document filing actions.

Responsibilities :
• Manages the end-to-end MLR process.
• Responsible for scheduling, setting the agenda, and leading Review Committee meetings.
• Add live discussion notes for comments discussed in Veeva Vault
• Scribe meeting minutes, circulate draft meeting minutes for Committee approval and finalize and file approved minutes
• Ensure all covered communications are properly vetted through the review process utilizing the online review system (e.

g., Veeva Vault PromoMats and Vault MedComms)
• Cascade and enforce any new policies and guidelines related to review of materials.
• Verifies that materials are assigned to the appropriate review path
• Rejects incomplete submissions and materials that are not review ready
• Facilitates / documents discussion in live meetings.
• QCs Final Document vs. Approved Document
• Supports FDA 2253 submissions with MLR Regulatory Reviewer / Partner

Experience :
• At least 2 years of experience in a healthcare agency or pharmaceutical company
• Experience with use of Veeva Vault PromoMats / MedComms
• Experience in Scientific Writing / Scientific Reviewing / MLR
• Project management

Immediate joiners are preferred

Should be comfortable to work in both US and UK shifts

EOE : Our client is an Equal Opportunity Employer and Prohibits Discrimination and Harassment of Any Kind : We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment.

All employment decisions at our client are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, *** (including pregnancy), age, physical, mental or sensory disability, HIV Status, ****** orientation, gender identity and / or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.

We will not tolerate discrimination or harassment based on any of these characteristics

India
Rajasthan
Kota-Kota Show on map Get directions