What are the responsibilities and job description for the Medical Quality & Compliance / Regulatory Affairs Manager position at Montek System?
Job Details
Medical Quality & Compliance / Regulatory Affairs Manager
PharmD Degree preferred, background medical information programs
Work Schedule: Mon - Fri, Business Hours
Hybrid role: 50% in office per two week period
Will play an important role in the day-to-day engagement quality. The manager will have direct responsibility for reviewing worldwide cases in accordance with our policies to ensure quality measures are achieved, including analysis and feedback of quality related data. The manager will also be involved in vendor management quality activities.
Key Responsibilities:
o Ensures Medical Information case generated within our markets are reviewed and measured against our quality standards and reported in a timely fashion in accordance with policies and procedures.
o Assist with identifying quality trends and develops quality improvement plans to enhance processes and delivery of
Medical Information in his/her assigned area(s).
o Ensures audit readiness both internally and externally within his/her area(s) of responsibility.
o Performs other duties and projects as assigned. Assist with maintenance of compliance related training records in
the electronic Learning Management System (LMS).
o Provide subject matter expertise during audits.
o Review and analyze training and QA data to improve performance and to provide excellent customer service by
enhancing the customer experience.
Skills and Characteristics of Ideal Candidate:
o Must be an effective communicator with excellent verbal and written skills both in comprehension and expression.
o Must be detail oriented and have excellent listening skills and ability to analyze and recognize subtleties in a
conversation.
o Must possess proven customer service skills.
o Must also possess a high level of energy and motivation.
o Ability to thrive in a fast paced environment and respond accordingly to high priority situations is essential.
Qualifications:
o Pharm D preferred
o 1-2 years of experience managing Medical Information programs to deliver better customer experience is preferred
o Prior Quality Assurance and/or training experience is preferred
o Strong business acumen with knowledge of the evolving healthcare landscape
o Solid organizational and time management skills, proven project management
