Medical Review Committee (MRC) Specialist

Title:
Medical Review Committee (MRC) Specialist

Company:
Ipsen Biopharmaceuticals Inc.

Job Description:

Are you looking for an opportunity to apply your promotional or medical review committee experience in Medical Affairs?

As Medical Review Committee (MRC) Specialist you will be responsible for performing the role of the US Medical Review Committee (MRC) coordinator for assigned product(s) to ensure that all medical materials are reviewed and approved in accordance with the MRC SOP. The MRC process utilizes significant cross-functional internal resources and it is important that this role can facilitate and lead MRC teams to consensus while meeting deadlines as well as be attentive to details while proofing materials. This role is important to ensuring that the company's US medical communications comply with Federal Regulations and Company Policies. This role reports into the Head of Medical Information.

Your role will involve:

• Ensures all MRC members, including agencies, are trained and adhere to the MRC processes and procedures
• Forecasts volume of materials that will be reviewed by assigned MRC Team through working with MRC Sponsors to develop and update MRC plans annually, quarterly, monthly and weekly
• Manages the MRC meeting calendar and ensures sufficient live meeting time is scheduled for the MRC team, as necessary
• Ensures materials are submitted, routed, approved and released in accordance with the responsibilities and timelines outlined in the MRC SOP
• Manage relationships between materials, for example ensuring that nomenclature and Job Codes are correct, and making certain that relevant associated materials are connected in the electronic system metadata
• Assist Global Sponsors by partnering them with Local Sponsors to ensure the MRC Process is followed. Identifies issues of noncompliance and helps identifies solutions to share with management as needed.
• Leads the triage of materials for review and confirms that all materials meet SOP established review criteria. Materials that do not meet the criteria are sent back to the owner or agency for rework.
• Facilitates MRC meetings to ensure efficiency and maintain focus on key issues, with the goal of bringing the group to consensus across all functions
• During the Review stage, ensures all reviewer comments on materials are clarified and resolved in accordance with published timelines and comment resolutions and outcomes are documented in the electronic review system
• Performs a final quality check of the material and ensures that all reviewer comments are incorporated, as well as confirming no other changes were made, prior to issuing the final approval of materials
• Manages expedited review process and coordinates MRC Escalation Meetings
• Supports the timely implementation of new MRC process changes to help ensure successful management of MRC process
• Facilitate development and maintenance of the MRC process materials, standard language/disclaimers, reference documents, and training materials in online document repository
• Manage all aspect of off-line and live reviews and collaborate with MRC Sponsors and reviewers to resolve materials offline, when feasible
• Runs monthly MRC metric Reports from Veeva, puts data into graphical format and maintains accurate document statuses in Veeva for assigned product

In return, you will bring:

• 2-4 years working with promotional or medical review committees
• Proficient in Veeva PromoMats and Adobe Acrobat commenting tools
• Proficient in Microsoft Office
• Experienced with proofreading technical documents

If this sounds like an exciting opportunity to work on the Medical Affairs team, apply today!

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.