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Boehringer Ingelheim Pharmaceuticals, Inc.
Associate Director, DRA Advertising & Promotion Review
Location: Ridgefield,
Connecticut-Danbury/Bridgeport
06877
Posted on:
10/7/2009 8:55:44 AM
Postion type:
Full time
Job Code:
MD05909
Required Education:
Salary:
DESCRIPTION
Position Summary:
Serve as primary DRA representative on assigned BI product promotion review teams, with the responsibility of reviewing and approving regulatory content of product promotion and communication materials, including sales training materials. Develop DRA best practices, working instructions, SOP’s for product promotion and compliance activities. Develop and maintain relationships with other internal BI departments involved in the product promotion and communication process. Serve as primary liaison to FDA (DDMAC) on regulatory issues concerning promotional materials (with minimal supervision).
Duties & Responsibilities:
* Provide regulatory leadership and support for the brand teams in review of promotional materials for prescription drugs. Attend promotional review meetings, review all promotional materials, and provide comments in accordance with marketing timelines and FDA regulations (requires minimal supervision).
* Develop DRA best practices, working instructions, SOPs for product promotion and compliance activities, to establish across brand standards and consistency (with minimal supervision).
* Review and approve 2253 submissions to DDMAC related to assigned products. Provide guidance and support to DRA regarding 2253 submission activities.
* Maintain regulatory expertise in product promotion compliance by keeping current with issued FDA (DDMAC) Warning and Untitled letters and attendance at product promotion seminars / workshops.
* Communicate new regulatory standards pertaining to prescription drug promotion and advertising to brand teams & BIPI management (with minimal supervision).
* Provide guidance / training / support within DRA regarding regulatory requirements for prescription drug promotion and advertising, to establish across- brand standards and consistency (with minimal supervision).
* Participate in the training of new employees, interns, and/or colleagues in other departments about prescription drug advertising and promotion regulations.
Requirements:
* Minimum of 4 years pharmaceutical industry experience with BS/BA (technical / scientific background, biology/chemistry), with at least 2 years experience in regulatory review of product promotion and communication materials, or related activities.
* Proficient knowledge of (1) prescription drug advertising and promotion regulations, (2) FDA (DDMAC) organization, and (3) regulatory compliance and applicable 21 CFR regulations
* Working knowledge of drug development, including clinical and post-marketing stages with a focus on the generation of clinical data to support marketing communications.
* Excellent communication and interpersonal skills.
* Excellent verbal, writing and presentation skills; detail-oriented.
* Good planning, organizing and decision-making capabilities: must be able to handle multiple priorities, resolve conflicts and solve problems with minimum supervision.
REQUIREMENTS:
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