• Pfizer Canada
  • $140,340.00 -140,340.00/year*
  • Camden , NJ
  • Pharmaceutical/Biotechnology
  • Full-Time
  • 883 Princess Ave

ROLE SUMMARY

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.

ROLE RESPONSIBILITIES

  • 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
  • QUALIFICATIONS

    Education:

  • 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.

    Sunshine Act

    Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.


    Associated topics: clinical, clinical development, clinical informatics, clinical trial, coordinator, lab, laboratory, research, research coordinator

    * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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