769 million patients were impacted by Novartis products in 2020. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
he purpose of this role is to work independently under limited supervision to provide strategic regulatory advice on advertising/promotion and medical materials to the US organization for assigned products, including launch products/indications, or complex and/or high-priority products in accordance with business goals and objectives, FDA regulations/guidance, PhRMA guidelines, and company policy.
Your responsibilities include, but are not limited to:
* Serve as a primary regulatory advertising and promotion reviewer for assigned products on Oncology Materials Approval Process ("oMAP") teams, including launch products/indications, or complex and/or high-priority products. Liaise with OPDP regarding advertising and promotion for assigned products, including products approved under Subpart H. Establish strong and positive working relationship with OPDP reviewers. Manage OPDP queries on assigned products. * Apply regulatory and therapeutic area knowledge to Brand Team's objectives and initiatives to develop solutions to complex US promotional issues. Ensure regulatory compliance while effectively managing business risks. * Maintain awareness of competitive activities by monitoring major US Medical meetings where assigned therapeutic area products are promoted. Prepare complaint letters to OPDP. * Serve as DRA Ad/Promo representative on Integrated Disease Medical Team (IDMT) for assigned disease areas. Conduct reviews of materials to be used by medical personnel in discussions with customers. * Serve as DRA representative on cross-functional committees, task forces, etc. Monitor 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. * Collaborate 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. Key Performance Indicators include: o Compliance with all regulatory obligations and Novartis policies o Ability to navigate in a matrixed environment and influence internal partners to achieve desired business outcomes o Ability to communicate effectively, manage issues, resolve conflicts, and mitigate risks