• Job Description

  Req#: 4892659

  ROLE SUMMARY

  This position will be housed in the newly formed Evidence Generation Platform, which is responsible for establishing scientific global leadership and stature through the generation of integrated, end-to-end observational real-world evidence serving all therapeutic areas. The Platform will combine two formerly disparate Pfizer functions to:

  enhance Pfizer’s ability to determine unmet medical needs; support current Product Development programs including finding alternatives and accelerated licensure pathways for new indications through the use of Real World Data (RWD), Real World Insights (RWI) and Real World Evidence (RWE); inform clinical practice on appropriate prescription and use of Pfizer’s products; in collaboration with PHI, strengthen the value evidence package for payers and access/policy decision-makers; support measurement of short- and long-term impact of Pfizer’s products to both patients and populations; support competitive differentiation.

  The Quality /Compliance/ Education Director(s) are key members of the Evidence Generation Team, who will be aligned to by Therapeutic Area (TA) and responsible for supporting the implementation of the Evidence Generation Platform quality plans, manuals, Clinical/Medical SOPs, division guidance & training etc. describing the execution of regulated activities to meet the requirements defined in Pfizer Corporate Quality Policy CP114 and the RDM QMS requirements.

  This role will coordinate and facilitate quality and training activities cross functionally for the BU related to Evidence Generation study activities, provide internal protocol review for ensuring correct study type and application of safety reporting rules for study type. Additional involvement in quality activities will include: quality event reporting/ CAPA development and remediation, new process development & implementation and study tracking activities.

  ROLE RESPONSIBILITIES

  • Collaborate with cross-functional teams to develop and implement quality activities to meet quality objectives for each assigned area.
  • Critical review of SOPs for Evidence Generation activity/study requirements.
  • Thorough understanding of GCP, RWE/RWD, GXP, regulatory requirements and relevant data quality standards.
  • Creation of WI, RF, Checklists, educational materials, etc for implementation of Evidence Generation standard principles.
  • Quality review of protocol drafts, to ensure studies are conducted in compliance with relevant SOPs and applicable internal, external, regulatory requirements
  • Coordinate and prepare deliverables for internal review processes, quality control assessments, and essential document archiving; deliverables may include risk management plans, CAPA Plans, interim/final reports, etc.
  • Communicate effectively to cross functional roles in TA and with external stakeholders.
  • Reporting quality metrics and analytics for Evidence Generation activities
  • Support audit/inspection readiness preparation and coordination including relevant QC activities for Evidence Generation activities
  • Participates in or leads projects as assigned by Quality Compliance Education Implementation Lead for all groups within scope
  • Address and triage questions pertaining to quality within Evidence Generation scope; escalates issues appropriately within the QMS structure
  • Creates and executes plans for process improvements under the guidance of the Evidence Generation Quality Compliance Head.
  • Manages risk appropriately to enable innovative solutions.
  • Looks to drive innovative ideas for efficiencies across Evidence Generation activities
  • Partners with key stakeholders for quality reviews, audits, investigations, etc, as needed.
  • Establish enterprise systems and tools.

  BASIC QUALIFICATIONS

  • BA/BS Degree in life sciences or health related field with 10+ years practical experience or MS/MBA with 8+ years, PharmD/PhD 6+ years and MD/DO with 3+ years.
  • Effective collaboration on virtual teams and proactive in optimizing ways of working.
  • Flexibility to engage global team members and stakeholders in disparate time-zones
  • Strong working knowledge of the technical and methodological aspects of registries, post-authorization safety studies, and observational study design and implementation.
  • Capable of independently managing complex registry and non-interventional study projects.
  • Skilled in functioning within a matrixed organization where managing through influence is required
  • Excellent interpersonal skills required: ability to understand and respond to multiple internal and external customers
  • Ability to influence stakeholders constructively and to minimize conflict
  • Strong project management abilities are essential.
  • Demonstrated ability to manage multiple projects (multitask) involving complex processes, competing deadlines and rapidly shifting priorities.
  • Change oriented, comfortable responding to unexpected demands with tight timelines, team player.

  PREFERRED QUALIFICATIONS

  • Proficiency in SharePoint/Teams
  • Proficiency in Microsoft Office applications
  • Fluent in English, both written and verbal

  ORGANIZATIONAL RELATIONSHIPS

  Reports to the Head of Evidence Generation Quality, Compliance & Education and works directly with various levels within EvGen Platform and Global Medical Affairs as well as other cross functional departments to develop and implement approaches, tools, and practices to ensure a robust quality culture and maintain processes to drive high standards of excellence and compliance across 1-2 BU categories.

  Will develop strong relationships with all cross functional team members including U.S. and Global Medical Affairs for TA categories, EM, IDM, WMS, GMEI HEOR/PHI, Clinical Development, Medical Governance, GPD, WRD, Legal and Compliance.

  Required to interact with all levels of leadership CMAO (and potentially above).

  
  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.
  

  PHYSICAL/MENTAL REQUIREMENTS

  Standard requirements

  NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Domestic and/or international travel up to 10% of time likely.
  • NYC/East Coast work hours coverage preferred.

  Other Job Details:

  Last Date to Apply for Job: September 05, 2023

  Eligible for Relocation Package: No

  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.

  Quality Assurance and Control

  #LI-Remote #LI-PFE

• About the company

  At Pfizer we know that great things happen anywhere people come together with one shared goal. And the greatest rewards are sometimes where you least expect them. The future of medicine is happening at Pfizer.

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