Manager, Regulatory Review
| Publication or Company |
Digitas Health |
| Job Type |
Public Relations, Sales/Advertising Sales |
| Salary |
Leave Blank |
| Benefits |
|
| Job Duration |
Full Time |
| Job Location |
Philadelphia, PA USA |
| Job Requirements |
Counting as clients many of the world's leading pharmaceutical, bioscience, and medical device companies, Digitas Health is a next-generation marketing agency that helps build healthcare brands that patients, caregivers, and healthcare professionals feel confident turning to and recommending when they are sick, in need, or helping others.
With offices in Philadelphia, New York, Boston and London, Digitas Health is frequently recognized as one of the best places to work by the Business Journals and as having the best work perks by CNN.com. The company is a recent Webby Award winner and the MM&M 2009 Agency of the Year.
Digitas Health is a unit of Digitas, leading global digital marketing and media agency.
We are looking for a Regulatory Review Manager to join our team. The Regulatory Review Manager (RRM) must follow the protocol established by our pharmaceutical company clients when submitting marketing materials for regulatory review. This includes preparing completed editorial content to Medical/Legal 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 Medical/Legal 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
• 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' Medical/Legal Review department, both to get information regarding submissions requirements and to answer procedural questions that arise during the Medical/Legal review process
• Create, update, and disseminate to the rest of the department procedure(s) specific to the clients the RRM supports.
SKILLS & EXPERIENCE:
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.
Skills .Benefits . |
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| Contact |
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| Special Instructions |
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