MLR Coordinator

This is a fully remote position, open to applicants in Kansas.

📋 Description

• Oversee the comprehensive Medical, Legal, and Regulatory (MLR) process for a specific client

• Organize, establish agendas for, and facilitate Review Committee meetings

• Record live discussion notes in Veeva Vault Scribe meeting minutes, distribute draft minutes for Committee approval, and finalize and archive approved minutes

• Ensure that all communications are thoroughly vetted through online review systems such as Veeva Vault PromoMats and Vault MedComms

• Distribute and implement new policies and guidelines pertaining to material review

• Confirm that materials are allocated to the correct review path

• Reject submissions that are incomplete or not ready for review

• Lead and document discussions during live meetings

• Conduct quality checks on final documents against approved versions

• Assist with FDA 2253 submissions and country-specific regulatory submissions alongside the MLR Regulatory Reviewer/Partner

• Aid in the development of project plans and support medical content development teams

• Help with the upload of materials into client review and approval platforms, including annotating and referencing

• Support Medical Affairs and Medical Information leadership in formulating and managing project plans for critical initiatives

• Contribute to the enhancement of processes and customer service linked to the MLR review process

• Carry out other assigned responsibilities

⛳️ Requirements

• Graduates in any Life Sciences / Biomedical field

• Exceptional communication skills in English, both verbal and written

• Minimum of 2 years of experience in a healthcare agency or pharmaceutical company

• Familiarity with Veeva Vault PromoMats / MedComms

• Background in Scientific Writing / Scientific Reviewing / MLR Project management

• Strong time management abilities

• Proficiency in meeting management

• Excellent customer service skills

• Proficient in Outlook and Microsoft Office Suite (Word, Excel, PowerPoint, and other Windows applications)

• Working knowledge of or familiarity with global healthcare compliance statutes and laws is preferred

• Capacity to perform tasks with a high level of independence requiring significant experience, skill, and knowledge

• Demonstrated ability to manage multiple tasks, prioritize effectively, and meet deadlines

• Capability to manage cross-functional projects

• Understanding of laws and regulations regarding US drug/device advertising and promotion, including industry best practices

• Knowledge of medical terminology is preferred but not mandatory

• Detail-oriented with a consistent focus on quality

• Ability to adhere to established processes and procedures and adapt to new practices and priorities as necessary

• Willingness to work full-time and be flexible with work scheduling as required by clients and management

• Graduates/Postgraduates in Pharmacy or Medicine are preferred

🏝️ Benefits

• Competitive salaries and benefits

• Equal Opportunity Employer

• Reasonable accommodation for applicants and employees with disabilities

• Full-time employment