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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