Medical-Legal-Regulatory (MLR) Coordinator (Remote/Contract)
Keen360, Inc., United States
Job Description
The MLR Coordinator will act as an un-biased third-party that will lead the process of the Medical, Legal, and Regulatory review of all advertising and promotional materials for a pharmaceutical client. Experience in Veeva Vault is a must. They will be responsible for QC’ing all submitted pieces, and managing the workflows in Veeva. The coordinator will schedule and run all review meetings. During the live meetings, the coordinator will moderate and facilitate conversation, while capturing any agreed upon changes in the platform. After a meeting, the coordinator will ensure that all changes agreed upon are carried through in each piece. After final approvals are received, the coordinator will then support the in-house regulatory affairs team to get them all necessary files for FDA submission. Strong organizational and follow-up skills are critical, as well as experience with HCP-facing marketing materials in the MLR process.
Requirements
Minimum of a bachelor's degree and 2-4 years of experience in the preparation of complex deliverables under tight deadline constraints is required.· Technical competency in Veeva Vault, Adobe Acrobat, and the Microsoft Office Suite are required.· Experience communicating with clients directly is required.· Clear communication and attention to detail are essential.· Clear, concise technical writing ability is strongly preferred.- Experience in Pharmaceutical Industry or Healthcare is required. Strong project planning and management tasks, business systems support functions and project costing techniques are also preferred.
Benefits
Keen360 is a Management Consulting firm that specializes in advising organizations to design Business strategies, develop operational efficiencies and deliver innovative solutions to achieve measurable results. Our projects range from pure design and development topics to more transverse transformation involving multiple business lines or regions.