Associate Director, DRA Advertising and Promotion (Oncology)

Job description

Job Description

Responsibilities:
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• Provides strategic regulatory advice on advertising and promotion materials and activities 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.
• Liaison with OPDP regarding advertising and promotion for assigned products, including products approved under Subpart H. 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 complex 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.
• Serves as DRA representative on Medical Product Team (MPT) for assigned products and conducts reviews of materials to be used by field 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 other DRA colleagues to provide input to study designs or US label with regard to feasibility of promoting potential data/claims.
• Participates in US labeling negotiations and FDA meetings as necessary.
• Ensures that changes in US Prescribing Information are reflected in current promotions and advertising.

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Desired profile

• BS Degree. Advanced degree desirable (MS, PhD, PharmD, or JD) with a minimum of two years' experience in a clinical or regulatory function.
• In-depth understanding of US regulations for drug promotion/advertising and US labeling.
• Ability to analyze and interpret efficacy and safety data.
• Strong understanding of business goals of the involved business franchise, marketing concepts and tools.
• Must perform independently with strong negotiation and decision making skills.
• 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 complex problems.



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