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 with 4+years’ relevant experience. + BA/BS with 6+ years’ relevant experience. + For external candidates, 1+ years’ experience in regulatory review of promotions for prescription drugs or other biologic products. + Experience leading development and execution of regulatory submissions of promotional materials for prescription drug or biologic products is preferred. + Experience working with external operational contractors supporting the work of regulatory affairs is a plus. + Experience writing or updating processes. + Experience working in project teams. **Knowledge & Other Requirements** + Demonstrated ability to be a fast learner. + Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed. + Demonstrates working knowledge of the role of regulatory affairs in achieving cross-functional business goals and objectives. + Knowledge of regulatory requirements and guidance for the promotion of prescription drug and biologic products. + Working knowledge of relevant regulatory or related systems is preferred. + Demonstrates strong analytical thinking skills, attention-to-detail, strong communication and writing skills, and project management skills, as evidenced through accomplishments in past roles. + Ability to lead and influence programs, projects and/or initiatives. + Strong interpersonal skills and understanding of team dynamics. + Proven ability to work successfully in a team-oriented, highly matrixed environment. + When needed, ability to travel. The salary range for this position is: Bay Area: $146,540.00 - $189,640.00. Other US Locations: $133,195.00 - $172,370.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. **For jobs in the United States:** Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf) YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf) Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. **For Current Gilead Employees and Contractors:** Please apply via the Internal Career Opportunities portal in Workday. Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.