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    Senior Manager Regulatory Affairs - Cambridge, Cambridgeshire, United Kingdom - Gilead Sciences, Inc.

    Gilead Sciences, Inc.
    Gilead Sciences, Inc. Cambridge, Cambridgeshire, United Kingdom

    6 days ago

    Default job background
    Part time
    Description
    Senior Manager Regulatory Affairs Vendor Governance page is loaded Senior Manager Regulatory Affairs Vendor Governance
    Apply locations United Kingdom - Cambridge time type Full time posted on Posted 6 Days Ago job requisition id R

    For Current Gilead Employees and Contractors:

    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 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.

    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
    maintains meticulous attention to project deadlines
    Expert knowledge of and interprets new regulatory requirements in area of responsibility, makes recommendations based on impact to existing processes and oversees implementation
    Has an appropriate level of IT skills in Microsoft Excel, PowerPoint and Word. Familiarity with other tracking or business intelligence tools as plus.
    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 objectives
    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
    It is the policy of Gilead Sciences, Inc.

    and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company.

    Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws).

    For Current Gilead Employees and Contractors:
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