THE POSITION
:
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. As part of the MLR team, the Medical Content and Review Specialist is responsible for managing all the MLR process for a dedicated client. The Medical Content and Review Specialist ensures that all administrative and program management support for the client’s MLR process operates effectively and in full compliance with all internal and external policies and regulations.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by:
MEDICAL CONTENT AND REVIEW SPECIALIST 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
MEDICAL CONTENT SUPPORT RESPONSIBILITIES
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.
MEDICAL AFFAIRS AND MEDICAL INFORMATION PROJECT MANAGEMENT SUPPORT
Support Medical Affairs and Medical Information leadership in developing and managing project plans for key initiatives
All other duties as assigned.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
Education
(i.e., degree required): Graduates in any Life Sciences / Biomedical field.
Must demonstrate excellent ability to communicate effectively in English, both orally and in writing.
Experience and/or Training
:
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.
Technology/Equipment
: Computer proficiency in Outlook and Microsoft Office Suite (Word, Excel, PowerPoint, and other Window applications).
All your information will be kept confidential according to EEO guidelines.
Our team is aware of recent fraudulent job offers in the market, misrepresenting EVERSANA. Recruitment fraud is a sophisticated scam commonly perpetrated through online services using fake websites, unsolicited e-mails, or even text messages claiming to be a legitimate company. Some of these scams request personal information and even payment for training or job application fees. Please know EVERSANA would never require personal information nor payment of any kind during the employment process. We respect the personal rights of all candidates looking to explore careers at EVERSANA.
From EVERSANA’s inception, Diversity, Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer, and our employees are people with different strengths, experiences, and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All of our employees’ points of view are key to our success, and inclusion is everyone's responsibility.
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