Job Description
The Senior Associate, Regulatory Review must follow the protocol established by our pharmaceutical company clients when submitting marketing materials for regulatory review.
This includes preparing completed editorial content to the Medical-Legal-Regulatory (MLR) review board (a board of experts typically consisting of medical doctors, lawyers and experts in FDA regulations), submitting materials to the client (both electronically and / or in hard copy as determined by the clients' specifications), and tracking the progress of each project through the various stages of MLR review.
DUTIES & RESPONSIBILITIES :
- Determine the time and effort required to complete each submission
- Establish a timeline and assign responsibility to the appropriate team members for the delivery of the components of the submission
- Create and / or oversee the creation of the components and ensure they conform to client and Digitas Health guidelines
- Maintain a comprehensive, accurate dashboard of all current and upcoming submissions including the stage of review, job codes, and deadlines
- Follow up with client liaison in a timely manner to ensure the submission is received on time and meets 100% of client expectations and specifications
- Act as the primary point of contact between the agency and the clients' MLR Review department, both to get information regarding submissions requirements and to answer procedural questions that arise during the MLR review process
- Create, update, and disseminate to the rest of the department procedure(s) specific to the clients supported
Qualifications
Minimum of a bachelor's degree and 2-4 years of experience in the preparation of complex deliverables under tight deadline constraints is required.
Technical competency in Internet Explorer, Adobe Acrobat, and the Microsoft Office Suite are required. Experience communicating with clients directly is required.
Clear communication and attention to detail are essential. Clear, concise technical writing ability is strongly preferred.
Experience in Pharmaceutical Industry or Healthcare is preferred.
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