** MED COMMS AGENCY EXPERIENCE REQUIRED **
Job Title: MLR Submissions Director
Location: Remote
About: Currently partnered with a growing medical communications agency dedicated to delivering high-quality, compliant, and impactful medical education and promotional materials. They are looking for an MLR (Medical, Legal, Regulatory) Submissions Director to oversee the regulatory requirements and submissions for promotional med ed projects.
Key Responsibilities:
- Ensure all promotional and educational materials meet regulatory requirements, including FDA, EMA, and other relevant guidelines.
- Oversee the submission process for MLR review, including preparing and submitting documents, tracking progress, and addressing feedback.
- Work closely with internal teams (medical writers, project managers, creative teams) and external stakeholders (clients, regulatory bodies) to ensure timely and accurate submissions.
- Maintain detailed records of all submissions, approvals, and communications with regulatory bodies.
- Provide training and guidance to internal teams on regulatory requirements and best practices for MLR submissions.
- Conduct thorough reviews of materials to ensure accuracy, consistency, and compliance with regulatory standards.
- Identify opportunities to streamline the MLR submission process and implement best practices to enhance efficiency and compliance.
Qualifications:
- Bachelor's degree in relevant field.
- 5+ years of experience in regulatory submissions within the pharmaceutical or medical communications industry.
- Strong understanding of regulatory requirements and guidelines for promotional medical education materials.
- Excellent organizational, communication, and project management skills. Attention to detail and ability to manage multiple projects simultaneously.
- Familiarity with submission management software and tools.
