Medical Content and Review Specialist

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,