Job Description:
• Lead the regulatory strategy and execution for promotional content, ensuring adherence to FDA regulations and internal guidelines.
• Act as the primary point of contact for MLR reviews, providing regulatory expertise and guidance to internal teams and clients.
• Develop and maintain regulatory policies, procedures, and training materials to ensure compliance across all teams.
• Conduct thorough reviews of promotional materials to ensure accuracy and compliance with relevant regulations.
• Track industry trends and changes in regulatory requirements, proactively updating internal processes and training as necessary.
• Mentor and develop the regulatory team to enhance their understanding of compliance challenges and best practices.
• Collaborate with clients to address regulatory questions and concerns, fostering positive relationships and ensuring satisfaction.
• Participate in senior leadership meetings to report on regulatory compliance status and present improvements.
• Work to increase the efficiency of the MLR review process through streamlined workflows and enhanced communication.
Requirements:
• Strong knowledge of FDA regulations and MLR processes.
• Demonstrated ability to lead teams and manage multiple projects simultaneously in a fast-paced environment.
• Excellent written and verbal communication skills, with a keen eye for detail.
• Proficient in the use of project management and collaboration tools, as well as Microsoft Office Suite.
• Previous experience in agency settings or working directly with pharma clients
Benefits:
• Medical, Dental & Vision Insurance. We cover a generous portion of employee contributions
• 401K plan. We invest in present and future you, which is why we offer a generous match and immediate vesting on our plan
• Parental Leave. Generous paid time off for parents to bond with their newest addition
• Professional Development. Each employee has an annual budget to allocate to professional development opportunities. Employees are encouraged to take a workshop, attend a webinar, join associations, and do anything else that will help them grow in their careers.
• And more! We offer flexible time off, life insurance, LTD, a robust employee assistance program, and more!
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