The SOCC Lead will support the delivery of a robust vendor engagement infrastructure (processes, systems/tools) for Business Operations and Sourcing customers in support of Safety, Regulatory, and Clinical Development in areas such as: business process support, vendor assessment & onboarding, monitoring sourcing strategy framework, sourcing and contract compliance and audit/inspection support.
Monitor and support compliance with sourcing and contracting
Support audit/inspections/litigation readiness and responses
Support development and execution of suite of vendor engagement tools including vendor assessment, vendor utilization, study awards and other tools to enable better transparency, study and functional line planning
Support the review, oversight, monitoring and remediation of QMS09 business process
Support the development of a fit for purpose vendor assessment process
Manage and triage of early stage interests for vendor engagement where there might be a need for vendor assessment
Provide guidance and expertise to teams for required vendor onboarding and engagement activities
Support evolution and execution of fit-for-purpose governance programs which hold vendor accountable to relationship commitments maintains line of sight into performance and quality issues
Bachelor s degree is required. An advanced degree is preferred.
Prior Experience / Attributes Preferred:
8+ years required If Bachelor s degree OR 4+ years clinical trial experience required with advanced degree
Extensive background in clinical trial conduct, global clinical trial operations, and a thorough understanding of the processes associated with project and study management, monitoring, clinical and regulatory operations
Demonstrated experience and understanding of risk management within clinical trial execution
Business experience and understanding of vendor engagement and contracting processes
Good Clinical Practice (GCP), quality systems infrastructure, and 3rd party supplier management experience
Ability to support document requests and create tools for internal audits, regulatory agency inspections, and litigation
Excellent analytical management skills
Demonstrated sound business acumen and judgement
Models key behaviors of customer focus; integrity and trust
Deals with ambiguity is creative and has ability to adapt in real-time
Drives for results, plans, manages and measures work
Multi-tasking; prioritizing; coping with high work volume
Ability to meet tight deadlines
Ability to work autonomously as well as working within a team
General knowledge of applying continuous improvement tools to business process improvements/business process re-engineering
Demonstrated experience to manage and improve large complex processes and/or business operating models
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Occasional travel for business/team meetings.
During exceptional circumstances, need to work non-traditional hours (such as during a regulatory agency inspection)
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
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