Manager, Regulatory Affairs Advertising and Promotion

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description
 

Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. RA Ad/Promo provides strategic regulatory guidance and input on Gilead's commercial and corporate communications, and plays a critical role ensuring that these activities are compliant with governing laws, regulations, and Gilead policies and procedures, while enabling the business to compliantly meet its goals and objectives. This group also represents Gilead's commercial activities to U.S. regulatory agencies.

You will provide commercial regulatory support for assigned brands, therapeutic area, and other projects. You may review and approve or co-review/approve promotional materials. You may manage external operational contractor support, including advising on OPDP submission requirements for accelerated approval and launch submissions, as applicable. You may initiate and/or contribute to local process improvements for activities relating to the work of RA Ad/Promo.

You may train cross-functional partners and teams on promotional material submission requirements. You will assist or serve as the Promotional Review Committee (PRC) Chair for one or more brands or therapeutic areas. With management oversight, you will provide regulatory guidance on new promotional concepts and campaigns. You may represent RA Ad/Promo in Regulatory Project Teams. You may also attend labeling meetings.

EXAMPLE RESPONSIBILITIES:

• Provides commercial regulatory support to assigned products or therapeutic area and projects with managerial oversight, as appropriate. Conducts co-review and/or review and approval of promotional materials.

• May train external contractors on Gilead submission processes and advise on submission requirements for promotional materials, including accelerated approval and launch submissions.

• May manage external operational contractors, as necessary.

• May serve as group lead for external operational contractor support, including managing division of responsibilities and coverage plans.

• Provides training to cross-functional team members on promotional material submission requirements, as needed.

• Assists or serves as PRC Chair for one or more brands or therapeutic areas.

• Maintains a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products.

• May initiate and/or contribute to local process improvements for activities that relate to regulatory advertising/promotion.

• May provide regulatory guidance on new marketing concepts, messages, and campaigns with managerial oversight.

• Represents RA Ad/Promo at Regulatory Project Team meetings as needed.

• May attend labeling meetings as needed, with managerial oversight.

• Seeks assistance from others as needed.

• Supports and helps coordinate the training of new Associates in the Regulatory Ad/Promo group, as needed.

• Ensures own work complies with established practices, policies, and processes, and any regulatory or other requirements.

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Education & Experience

• PharmD/PhD with some relevant experience.

• MA/MS/MBA