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Director, Advertising and Promotion Policy 2 positions (Regulatory Affairs)
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Director, Advertising and Promotion Policy 2 positions (Regulatory Affairs) : GlaxoSmithKline
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| Job Number |
73362 |
| Employee Type |
Full Time |
| Company Name |
GlaxoSmithKline |
| Location |
RTP
North-Carolina
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| Salary (year) |
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| Experience |
2 to 5 Years |
| Start Date |
1/31/2012 |
| Industry |
Pharmaceutical |
| Job Type |
Regulatory-Affairs |
| Relocation |
Required |
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| Description |
Basic Qualification
• Undergraduate degree in a biological or health care scientific discipline or equivalent
• 7 to 10 years of experience in pharmaceutical or biologics regulatory, or scientific disciplines with a demonstrated understanding of the drug development process, protocol and clinical study design
• At least 5 years in the review of prescription drug advertising and promotion for compliance with applicable FDA laws, regulations and guidance documents
• Demonstrated history of successful interactions with OPDP and multi-disciplinary teams
Details
The Director Advertising and Promotion Policy duties include:
• Providing strategic and operational leadership to Marketing Brand Teams, Legal, and Medical Affairs in the development of advertising and promotion for the US market (for key company assets) in accordance with business goals and objectives, FDA regulation, PhRMA guidelines and company policy
• Providing input on promotional implications of proposed clinical study designs
• Ensuring alignment of development and commercial objectives, analyzing whether promotional claims are supported and providing insight, judgment and sound decisions on promotional programs and tactics for assigned products
• Communicating effectively with reviewers within OPDP to expedite resolution of issues relating to assigned products
• Acting as a credible, influential, respected spokesperson for assigned products during interactions with senior management and OPDP reviewers
• Managing interactions with OPDP including responses to regulatory inquiries or enforcement actions, preparation of complete, accurate, and high quality submissions for advisory comments
• Maintaining a deep and current awareness of evolving FDA regulations and interpretations, FDA advisory comments, enforcement letters and policy issues affecting the pharmaceutical/biologics industry and communicating relevant information appropriately to stakeholders
• Acting as internal expert on FDA regulations governing the promotion of assigned products
• Working independently and recommending appropriate actions for proposed advertising and promotion, often with little or no precedent
• Helping to ensure labeling that optimizes the successful commercialization of assigned GSK product by applying an in-depth understanding of issues involved with the development of product labeling for the relevant GSK asset and knowledge of labeling for key competitor products
• Providing leadership on copy approval teams with recommendations that are recognized as well-reasoned, valid and appropriate
• Advising whether proposed clinical trial designs will support future promotional claims
• Identifying continuous improvement opportunities and ensuring the application of key learnings across assigned brands
• Actively involved as an influential leader within multiple cross-functional US Pharma and R&D teams with senior membership; participating in dispute resolution meetings with senior management
• Representing the department or GSK in company, government and trade association working groups with a focus on advertising and promotion standards and guidelines |
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| Requirements |
Preferred Qualification
• Advanced degree in biological or health care scientific discipline (or MD)
• Demonstrated history of successful interactions with multiple OPDP reviewers for a variety of products, across a range of therapeutic areas |
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| Contact Info |
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Apply online at company website |
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