Regulatory Specialist

Terumo BCT, Inc.•Denver, CO

1d•$39 - $49•Onsite

About The Position

The Medical/Legal/Regulatory (MLR) Specialist is a key member of the TruSource team, responsible for the day-to-day operational execution of the MLR review and approval process. This role manages administrative and workflow-related activities, provides frontline process support to users, and serves as a central point of coordination to ensure materials move efficiently, accurately, and in accordance with established policies through the MLR lifecycle. The MLR Specialist focuses on consistent execution, operational support, and system accuracy, and works closely with content owners, reviewers, and approvers to support timely and compliant completion of MLR reviews.

Requirements

Bachelor's degree in science, marketing, or communications
Minimum 1 year of experience supporting content review and approval processes in a regulated environment.
Experience in a medical device or similarly regulated industry required.
Experience with electronic document management systems and SharePoint required.
Familiarity with digital and print design processes and associated software applications.

Nice To Haves

Prior experience using Veeva Vault PromoMats in a production environment preferred.

Responsibilities

Acts as a liaison between stakeholders of the MLR process to ensure timely and accurate review of material going through the MLR process meets internal guidelines and requirements.
Manage the Veeva Vault PromoMats system submission process to ensure all content metadata and deliverables are included within project requirements.
Schedule and lead MLR meetings, prepare agendas, and consolidate meeting minutes.
Responsible for coordinating and holding weekly and ad-hoc meetings.
Responsible for creating reports that will be sent out to all functions within the MLR area.
Maintain organized project management related information and provide to appropriate stakeholders.
Coordinate and provide communication updates to user groups, management, and project teams.
Perform Veeva Vault PromoMats system training to new system users.
Establish and maintain positive relationships with cross-functional stakeholders and team members.
Prioritize and balance multiple competing priorities within and across multiple projects at the same time.
Contribute to a continuous learning and process improvement environment.
Proofread and check documents for accuracy, as well as consistency, ensure that claims are properly referenced to the claims database.
Ensure material messaging is aligned with corporate standards, FDA, and global device regulations.
Manage TruSource Veeva system updates and provide any associated updates / training to all stakeholders and team members.
Support all TruSource Veeva system audits or inspections.
Develop, update and/or maintain SOPs pertaining to review and approval processes.
Maintain familiarity with TBCTs products and indications, regarding on-label and off-label communications, including scientific information communications.
Identify opportunities for ongoing process improvement and develop suggestions to improve operational approaches