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VP, Study Quality Control & Compliance, RWE Platform

Employer
Pfizer
Location
La Jolla, California, United States;Lake Forest, Illinois, United States;United States - Washington - BothellCollegeville, Pennsylvania, United States;
Salary
Competitive
Closing date
Jun 2, 2024

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Discipline
Other, Legal/Regulatory Affairs, Manufacturing/QA/QC
Position Type
Full Time
Job Type
President/CEO/Director/VP
Organization Type
Pharma

Job Details

The Real World Evidence (RWE) Organization: The Chief Medical Affairs Office's RWE organization is responsible for establishing global scientific leadership and stature through the generation of integrated CMAO observational real-world evidence serving all therapeutic areas from post-proof of concept (POC) trials through Loss of Exclusivity (LOE) for priority pipeline candidates, pipeline supplementation through business development, and marketed inline products. CMAO RWE centralizes RWE, epidemiology, outcomes research, RW-relevant health informatics, and biostatistics talent from global, international developed and emerging markets into one team to drive quality and efficiency for CMAO-sponsored study activities.

ROLE SUMMARY

The RWE Study Quality Control & Compliance organization is responsible to ensure all CMAO led RWE activities related to observational research studies, hybrid interventional and/or RWE trials comply with all applicable regulations, codes and standards, and uphold a quality- and Integrity-focused culture in which each person is required to carry out their responsibilities with proper regard for quality. In addition, this team ensures the highest priority is placed on the safety and efficacy of our products, the safety of our patients, the integrity of data, and the trustworthiness of interactions with our Stakeholders.

The VP RWE Study Quality Control and Compliance role leads a team of Sr Director- through Manager-level quality specialists in therapeutic are a dedicated teams and specialized function-related areas. The VP's leadership team will serve as points of contact for CMAO led RWE Quality & Compliance needs including describing the execution of QMS-regulated activities within their area in alignment with the RDM QRC/Medical Quality Oversight Committee (MQOC).

The VP will be responsible for collaborating with Pfizer's Senior Leadership cross functionally to understand and translate health authorities' perspectives on the regulatory use of RWE and /new RWE guidance as well as develop actionable business processes to ensure high quality and timely delivery of compliant RWE projects. Understanding how other stakeholders such as HCPs, professional societies understand and use RWE will improve the VP's ability to address the risks associated with various data-use cases. In addition, the VP will focus on addressing regulatory issues related to a wide variety of primary, secondary health and health-related data sources. This role develops KPIs and success metrics with each of their RWE Leadership colleagues and in partnership with the MQOC to ensure alignment. They direct their teams to work in -matrixed cross-functional teams to review the design and study concepts of draft protocols for RWE and compliance with Pfizer standards.

Within the CMAO organization, this leader will work with other senior leaders and in collaborations with peers including the RWE Leadership team leads and team members in RWE Strategic Planning & Business Operations, RWE Clinical Affairs & Clinical Operations, and RWE Platforms & Partnerships.

Outside of the RWE organization, the VP will work with leaders from other CMAO functions, Biostatistics & Data Management, Global Regulatory Affairs, Clinical Pharmacology / Pharmacometrics, HV&E , Legal/Compliance, Worldwide Medical and Safety, and others to achieve research and business objectives. They will also serve as an external face for CMAO led RWE Quality & Compliance study execution, providing expert knowledge to its leaders. They will serve as a trusted expert with study / analytical KOLs, key regulatory agencies (e.g., FDA in the US, EMA in Europe, MHRA in the UK, PDMA in Japan, CDE in China), HTAs/Payers, and other stakeholders.

This role will be responsible for integrating into the MQOC/PVR QOC as part of the Pfizer QMS with cross-functional partners, determining the best approaches and process designs, selecting appropriate real world data quality standards, and ultimately for enabling the teams to deliver quality all in-scope evidence. They will monitor their teams' performance and report metrics, challenges, and opportunities back to the RWE CMAO and MQOC/PVRQOC as appropriate.

ROLE RESPONSIBILITIES
  • Internal collaboration and alignment with MQOC to develop and implement and operationalize a c study quality monitoring for CMAO RWE activities. Oversight of RWE response and remediation plans related to internal audit findings for CMAO
  • Direct oversight of the RWE Platform study quality monitoring and audit readiness/remediation program in partnership with MQOC
  • Serves as advisor to MQOC for initiatives that may impact RWE/Evidence generation and the quality plan.
  • Leads the creation of solutions to highly complex, multi-faceted, and unique problems. Has a problem-solving and lifelong learning mind set.
  • Influences organization-wide decisions and is accountable for decisions related to RWE Platform quality activities.
  • Reports to CMAO LT on CMAO RWE findings, inefficiencies and gaps, site weaknesses, ineffective procedures, policy exceptions and discrepancies and, as needed, recommends appropriate corrective actions. • In partnership with the MQOC, perform trending analysis of CMAO RWE quality issues from audits, quality events, or compliance issues and addresses trending issues with appropriate personnel for resolution and reports metrics in management review.
  • In partnership and alignment with MQOC, ensures the development and delivery of RWE quality monitoring oversight and tracking activities.
  • Ensures training programs related to RWE quality and compliance activities are suitable and effective.
  • Accountable for maintaining CMAO RWE quality t program's processes and procedures conformation to established Pfizer standards and guidelines.
  • Influences senior leadership of Pfizer and the external environment.
  • Timely escalation of any quality, human resource, environmental, safety or product issues.
  • Is accountable for creating an environment where Quality, Continuous Improvement, Learning and Innovation are embedded in day-to-day operations across the CMAO RWE organization and Medical Affairs.
  • Develops and defines the overall people, technological and financial resourcing strategy for Enterprise or Division


BASIC QUALIFICATIONS

Candidate will demonstrate 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.
  • MS, MSJ, MBA +18 yrs relevant experience Global Clinical and Medical affairs, Pharma QMS Development and Management, Regulatory Affairs, Clinical Quality, GCP audit readiness Regulatory Inspections experience; or
  • BS + 20 Yrs relevant experience Global Regulatory affairs, Pharma QMS Development and Management, Clinical Quality, GCP audit readiness, Regulatory Inspections experience.


Experience required in:
  • GXP Quality Management System development and oversight;
  • Business process development and document management, including Policies, SOP's and all other supporting document types;
  • Medical Affairs, and epidemiological study development and data quality standards.


Demonstrated expertise in at least two categories.
  • Familiarity with pharmaceutical product development; and non-interventional/observational research studies.
  • Experience having led and grown (staff and budget) at least one organizational structure with substantial supervisory


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Domestic and/or international travel up to 20% possible

Other Job Details:

Last Date to Apply for Job: May 31st, 2024

Additional Location Information: US - Any Pfizer site

Eligible for Relocation Package: No

#LI-PFE

The annual base salary for this position ranges from $262,100.00 to $436,800.00.* In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 30.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

* The annual base salary for this position in Tampa, FL ranges from $235,900.00 to $393,100.00.

Relocation assistance may be available based on business needs and/or eligibility.

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.

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. This position requires permanent work authorization in the United States.

Quality Assurance and Control

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