Senior Manager Regulatory Affairs Vendor Governance

仕事内容

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 objectives

Knowledge 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