Senior Manager Regulatory Affairs Vendor Governance
2 weeks ago
Job Description
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.
We empower our leaders to step up, share ideas, listen, learn, and lead. We’re welcoming bright, diverse, and imaginative minds; we’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.Job Description
Regulatory Affairs Vendor Governance is a function within the RA Business Operations group supporting all of Gilead RA’s subfunctions. Vendor Governance is responsible for the selection, implementation, governance, relationship management, tracking, and overall success of the vendor partnerships utilized by Regulatory Affairs.
Gilead Sciences is seeking an experienced individual to join the Regulatory Affairs Vendor Governance team. This position will report into the Head of Vendor Governance. The candidate will be responsible to provide expertise to multiple stakeholders and in complex vendor transition and governance activities, working closely with the Quality and Patient Safety teams and other development colleagues for effective vendor management including ensuring appropriate outsourcing KPIs and reporting of metrics in place, best in class vendor onboarding and training approaches, vendor relationship management and optimal processes for vendor partnerships. The role would suit someone with strong communication skills and an ability to cope with a fast pace and moving targets, broad RA/RO experience and experience in RA vendor management and partnerships. In addition, an enthusiasm for understanding the business needs, leveraging the skill set of the existing teams and making a difference.
Job Skills:
Own initiatives and day to day responsibilities in support of vendor oversight within RA Negotiation and problem solving between Gilead RA leads and Vendor resources Able to gather information or assign tasks or activities for one or more projects to manage competing priority jobs, and delegates special projects to junior staff if applicable and as needed Demonstrates excellent technical or analytical knowledge base, with ability to assess data, processes and understand the regulatory or process implications Demonstrates excellent verbal and written communication skills; has ability to provide direction to a team and to influence peers and team members appropriately Demonstrates excellent attention to detail, teamwork and initiative; maintains confidentiality; maintains meticulous attention to project deadlines Develops solutions to a wide range of complex problems which require the regular use of ingenuity, creativity, and innovation, ensuring solutions are consistent with organization objectives; develops concepts, techniques, standards, and new applications based on professional principles and theories; Serves as consultant to RA in area of vendor expertise Expert knowledge of and interprets new regulatory requirements in area of responsibility, makes recommendations based on impact to existing processes and oversees implementation Pro-actively recognizes issues or barriers and offers solutions to resolve Maintains knowledge of company disease and therapeutic areas Has an appropriate level of IT skills in Microsoft Excel, PowerPoint and Word. Familiarity with other tracking or business intelligence tools as plus. Able to work as a member of a cross-functional team Actively participates in RA and cross functional meetings and shares information on projects and challenges openly Participates in the development of RA Vendor Governance goals in line with department and company wide strategic objectivesKnowledge and Other Requirements
BA/BS with 8+ years relevant experience Previous experience in multiple aspects of Regulatory Affairs including partnering with vendors – several years’ and significant experience preferred Experience working with offshore vendors required Project management/Initiative experience preferred or experience in managing complex projects Has an excellent knowledge and understanding of applicable regulatory requirements Ability for occasional travel
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.
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For jobs in France:
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