Director, Regulatory Advertising and
Promotion
Overview:
Questcor is a specialty biopharmaceutical company which was awarded Forbes’ Magazine’s #1 Best Small Company award in 2011 and Orange County Register’s #1 Best Large Company of 2012. We help patients with serious, difficult-to-treat autoimmune and inflammatory disorders. Currently, we are supporting research in a number of rare conditions, including in treatment-resistant patient populations, where there is significant need for better therapeutic options.
The Company booked $548 million in net sales during the 12 months ended March 31, 2013, which represents a 500% increase from the equivalent period ended three years ago. The Company has solid margins, positive cash flow, a strong product base and a dedicated US sales force. Excellent top line growth momentum continues as Questcor continues to pursue its growth strategy. Market capitalization is approximately $2B.
We are currently seeking an Director, Regulatory Advertising and Promotion.
This position will be primarily responsible for managing regulatory activities involving assigned marketed products including (1) review of promotional labeling and advertising; and 2) preparation and filing of documents that support the marketing applications, and (3) interpretation of relevant federal and international regulations.
Questcor is a specialty biopharmaceutical company which was awarded Forbes’ Magazine’s #1 Best Small Company award in 2011 and Orange County Register’s #1 Best Large Company of 2012. We help patients with serious, difficult-to-treat autoimmune and inflammatory disorders. Currently, we are supporting research in a number of rare conditions, including in treatment-resistant patient populations, where there is significant need for better therapeutic options.
The Company booked $548 million in net sales during the 12 months ended March 31, 2013, which represents a 500% increase from the equivalent period ended three years ago. The Company has solid margins, positive cash flow, a strong product base and a dedicated US sales force. Excellent top line growth momentum continues as Questcor continues to pursue its growth strategy. Market capitalization is approximately $2B.
We are currently seeking an Director, Regulatory Advertising and Promotion.
This position will be primarily responsible for managing regulatory activities involving assigned marketed products including (1) review of promotional labeling and advertising; and 2) preparation and filing of documents that support the marketing applications, and (3) interpretation of relevant federal and international regulations.
Responsibilities:
- Serve as regulatory team member on promotional review
committee;
- Reviews and approves promotional, advertising, and
disease-state educational materials for commercial products; manage
cross-functional review team
- Provides strategic context and advice on regulatory
issues relating to promotion and advertising
- Interact effectively with internal (e.g., Sales and
Marketing, Medical, Corporate Compliance, and Legal) and external (e.g.,
the FDA’s Office of Prescription Drug Promotion [OPDP]) stakeholders.
- Reviews content and format of marketing materials and
other documents, assuring compliance with corporate policies, federal
regulations and guidelines, and product development objectives;
- Reviews regulatory guidelines and publications to keep
apprised of new regulatory developments
- Participates in commercial meetings to provide a
regulatory perspective on marketing strategies, implementation and
promotion objectives
Director, Regulatory
Advertising and Promotion
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