- Provides commercial regulatory support to high-volume brands or therapeutic area and projects without managerial oversight, as appropriate. Reviews and approves promotional materials.
- Serves as PRC Chair for one or more high-volume and complex 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.
- Serves as regulatory liaison to FDA/CDER/OPDP or FDA/CBER/APLB for assigned products, with managerial oversight, as appropriate.
- May lead local cross-functional process improvements or other special projects. May initiate and/or contribute to global process improvements.
- Provides regulatory guidance on new marketing concepts, messaging, and campaigns.
- Represents RA Ad/Promo at Regulatory Project Team meetings.
- Represents RA Ad/Promo at labeling meetings and provides strategic regulatory guidance.
- Mentors RA Ad/Promo and cross-functional team members as needed.
- May have one or more direct reports.
- 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 4+ years' relevant experience.
- MA/MS/MBA with 8+years' relevant experience.
- BA/BS with 10+ years' relevant experience.
- For external candidates, 4+ years' experience in regulatory review of promotions for prescription drugs or other biologic products.
- Significant experience leading development and execution of regulatory submissions of promotional materials for marketed prescription drug or biologic products.
- Significant experience contributing to the development of commercial regulatory or related strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional teams for multiple products.
- Experience chairing/leading promotional review committees or other relevant regulatory governance committees.
- Experience working directly with regulatory agencies in regulatory submissions and negotiations is a plus.
- Line management (direct reports) experience is a plus.
- Demonstrated abilities to effectively delegate and manage others, as evidenced through either past people management or matrix management responsibilities.
- Experience working with external contractors supporting the work of regulatory affairs is a plus.
- Experience authoring and/or implementing processes.
- Significant experience participating in cross-functional projects and teams.
Knowledge & Other Requirements - Demonstrates in-depth knowledge of current trends in regulatory affairs and is able to apply this to advance and accelerate regulatory strategies for assigned products or projects.
- Demonstrates advanced regulatory and business knowledge and advanced analytical abilities, as evidenced by strengths in assessing complex, multidisciplinary data, understanding and effectively advising on regulatory implications.
- In-depth knowledge of promotional regulations and guidance for prescription drug and biologic products, including industry best practices and standards.
- Working knowledge of relevant regulatory or related systems is preferred.
- Demonstrates ability to rapidly learn new therapeutic areas.
- Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
- Strong interpersonal skills and understanding of team dynamics.
- Strong communication and organizational skills.
- Strong negotiation and conflict resolution skills.
- When needed, ability to travel.
The salary range for this position is: $177, $230, 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:
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
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 log onto your Internal Career Site to apply for this job.
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Associate Director, Regulatory Affairs Advertising and Promotion - Foster City, United States - Gilead Sciences, Inc.
Description
Associate Director, Regulatory Affairs Advertising and PromotionUnited States - California - Foster CityUnited States - New Jersey - Parsippany
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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 manage the commercial regulatory strategy and execution of such for one or more high-volume and/or otherwise complex brands or therapeutic areas. You may manage, oversee, and review the work of one or more direct reports. You will represent the commercial regulatory perspective at and chair high-volume Promotional Review Committee (PRC) meetings for complex brands. You may lead local cross-functional process improvements or other special projects. You will provide strategic and operational regulatory guidance on new concepts, campaigns, and product labeling for the assigned brands. You may manage complex interactions related to promotional materials with regulatory agencies. You will communicate relevant updates or changes to cross-functional leaders and teams.
EXAMPLE RESPONSIBILITIES:
