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Tech Stack
Tools & technologiesVault
About the role
Key responsibilities & impact- 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)
- Verify that materials are assigned to the appropriate review path.
- Reject incomplete submissions and materials that are not review ready.
- Facilitate/document discussion in live meetings.
- QCs Final Document vs. Approved Document
- Support FDA 2253 submissions, or country specific regulatory submissions with MLR Regulatory Reviewer/Partner
- Support the development of project plans
- Support medical content development team
- Support upload of materials into clients’ review and approval platforms, including supporting annotating, anchoring references, etc.
- Support Medical Affairs and Medical Information leadership in developing and managing project plans for key initiatives
Requirements
What you’ll need- Graduates in any Life Sciences / Biomedical field
- 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
- Time management
- Meeting management
- Excellent customer service skills
- Computer proficiency in Outlook and Microsoft Office Suite (Word, Excel, PowerPoint, and other Window applications)
Benefits
Comp & perks- Medical
- Flexible work arrangements
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Scientific WritingScientific ReviewingMLR Project ManagementQuality ControlRegulatory SubmissionsProject Planning
Soft Skills
Time ManagementMeeting ManagementCustomer Service
