MLR Submissions Specialist

** MED COMMS AGENCY EXPERIENCE REQUIRED **

Job Title: MLR Submissions Director

Location: Remote

About: Currently partnering with a dynamic and growing medical communications agency committed to delivering high-quality, compliant, and impactful medical education and promotional materials. They are seeking an experienced MLR Submissions Director to lead and manage the end-to-end MLR (Medical, Legal, Regulatory) submission process for promotional and educational content.

Key Responsibilities:

• Lead the MLR submission process, ensuring all materials meet regulatory standards.
• Manage the preparation, submission, and tracking of materials through Veeva and Workfront platforms.
• Collaborate with cross-functional teams including medical writers, project managers, and creative teams to ensure timely and accurate submissions.
• Review and manage annotation grids, referencing, and fact-checking to ensure compliance and scientific accuracy.
• Address and incorporate detailed regulatory and client feedback, including complex annotations.
• Maintain meticulous records of submissions, approvals, and communications with regulatory bodies.
• Identify and implement process improvements to streamline submissions and enhance efficiency.

Qualifications:

• Bachelor's degree in relevant field.
• 5+ years of experience in regulatory submissions within the pharmaceutical or medical communications industry.
• Proven experience handling MLR submissions and navigating regulatory feedback.
• Excellent organizational, communication, and project management skills. Attention to detail and ability to manage multiple projects simultaneously.
• Familiarity with submission management software and tools.