Medical/Legal/Regulatory Specialist

Medical/Legal/Regulatory Specialist

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.

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.

Minimum Qualification Requirements

• Education: Bachelor's degree in science, marketing, communications
• Experience: Minimum 1 year of experience supporting content review and approval processes in a regulated environment. Prior experience using Veeva Vault PromoMats in a production environment preferred. 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.
• Skills: Strong project coordination and organizational skills to manage multiple tasks and deadlines in a fast-paced environment. High attention to detail and accuracy when managing documents, workflows, and system data. Strong interpersonal and communication skills to support users and coordinate with reviewers and content owners. Ability to follow established procedures and apply consistent process execution. Solid problem-solving skills to identify and resolve routine workflow and system issues. Ability to manage workload proactively and adapt to changing priorities. Customer-service mindset with responsiveness to user needs. Ability to work effectively as part of a team and support shared operational goals.

Physical Requirements

Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds. The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Target Pay Range: $39.00 to $49.00 - Hourly pay rate to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data Target Bonus on Base: 7.0%

We encourage your prompt application.

Terumo Blood and Cell Technologies