MLR Submissions Specialist


Remote
Permanent
Negotiable
Medical Communications
PR/551055_1751042099
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.

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