Associate Director, Drug & Advertising Promotions, Oncology job in East Hanover
|Employer:|| Novartis Pharmaceuticals|
|Category:||Research and Development|
|Job Type:||Full Time|
|State:||New Jersey (NJ)|
The Associate Director, Drug & Advertising Promotions works with some independence under supervision to provide strategic regulatory advice on advertising/promotion and medical materials to the US organization for assigned products in accordance with business goals and objectives, FDA regulations/guidances, PhRMA guidelines, and company policy.|
•Serves as a primary regulatory advertising and promotion reviewer for assigned products on Oncology Materials Approval Process ("oMAP") teams. May include a launch product or indication with manager oversight.
•Liaison with OPDP regarding advertising and promotion for assigned products, including products approved under Subpart H with manager oversight. Establishes strong and positive working relationship with OPDP reviewers.
•Manages OPDP queries on assigned products.
•Applies regulatory and therapeutic area knowledge to Brand Team's objectives and initiatives to develop solutions to US promotional issues.
•Ensures regulatory compliance while effectively managing business risks.
•Maintains awareness of competitive activities by monitoring major US Medical meetings where assigned therapeutic area products are promoted.
•Prepares complaint letters to OPDP with manager oversight.
•May serve as an ad hoc member on Medical Team for assigned products and may conduct reviews of materials to be used by medical personnel in discussions with customers
•Monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical companies published by OPDP, and by attendance of major FDLI, DIA and other industry/FDA meetings.
•Collaborates with DRA Development colleagues to provide input to study designs or US label with regard to feasibility of promoting potential data/claims with manager oversight.
•Participates/assists in US labeling negotiations and FDA meetings as necessary.
•Ensures that changes in US Prescribing Information are reflected in current promotion and advertising.
•Compliance with all regulatory obligations and Novartis policies
•Ability to navigate in a matrixed environment and influence internal partners to achieve desired business outcomes
•Ability to communicate effectively, manage issues, resolve conflicts, and mitigate risks• BS Degree or equivalent.
• Advanced degree desirable (MS, PhD, PharmD, or JD)
• Minimum 2 years in the pharmaceutical industry in a regulatory position
• Knowledge and understanding of US regulations for drug promotion/advertising and US labeling.
• Ability to analyze and interpret efficacy and safety data desired.
• Understanding of business goals of the involved business franchise, marketing concepts and tools.
• Must be able to work in a multi-disciplinary environment.
• Must process strong interpersonal and communication skills.
• Must have analytical and problem-solving skills associated with problem review and inquiries.
• Must be able to provide creative solutions to problems.