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Gilead Sciences, Inc. Foster, CA, United StatesAssociate Director, Regulatory Affairs Advertising and Promotion page is loaded · Associate Director, Regulatory Affairs Advertising and Promotion · Bewerben locations United States - California - Foster City time type Full time posted on Vor 11 Tagen ausgeschrieben job requisi ...
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Associate Director, Regulatory Affairs Advertising and Promotion - Foster, CA, United States - Gilead Sciences, Inc.
Description
Associate Director, Regulatory Affairs Advertising and Promotion page is loaded Associate Director, Regulatory Affairs Advertising and PromotionBewerben locations United States - California - Foster City time type Full time posted on Vor 11 Tagen ausgeschrieben job requisition id R For Current Gilead Employees and Contractors:
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 're nurturing them to foster an environment of inclusion and growth where innovation is encouraged.
We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.
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.
Join Gilead and help create possible, together.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. 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.
Ensures own work complies with established practices, policies, and processes, and any regulatory or other requirements.
PharmD/PhD 4+ years' relevant experience.
MA/MS/MBA with 8+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.Significant experience participating in cross-functional projects and teams.
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.
Working knowledge of relevant regulatory or related systems is preferred.Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
When needed, ability to travel.
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*.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 .
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTGilead 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:
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locations 2 Standorte time type Full time posted on Vor 3 Tagen ausgeschrieben 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.#
