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Manager, R&D Compliance Operations

Employer
Pfizer
Location
La Jolla, California, United States;New York City, New York, United States; Cambridge, Massachusetts, United States;Groton, Connecticut, United States;
Salary
Competitive
Closing date
Apr 23, 2024

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Discipline
Other, Legal/Regulatory Affairs
Position Type
Full Time
Job Type
Manager, Research Scientist
Organization Type
All Industry, Pharma

Job Details

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will be a member of Pfizer's dedicated and highly effective quality assurance and control team. You will be responsible for activities involved in developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and guidelines. In this role, you will manage and support the operational process and compliance system infrastructure that helps R&D colleagues compliantly engage in various external R&D activities such as, engaging with healthcare professionals (HCPs) for consulting services, developing scientific and technical content for external publication and presentation, and providing funding support to nonprofit organizations in the form of charitable contributions and corporate sponsorships. The individual in this role must be knowledgeable of healthcare compliance and continuous improvement principles, as they provide compliance review, system management, and serve as the team's rapid response expert to address process questions and/ or issues from across Pfizer's R&D units. This role is responsible for issue tracking and risk analysis, including transactional monitoring, to inform and pull through enhancement opportunities and quality improvements in the different R&D activity areas. Additional responsibilities include ongoing assessment and identification of external environment trends/best practices as well as activity reporting across Pfizer's R&D units. Further, the individual in this role must have excellent project management, communication, and writing skills, as they are responsible for providing oversight of designated vendors on system support projects and will oversee the development of core communications, SOPs, and/or colleague training materials. Individual project work to meet the team's semester-based goals, as well as project management, budget tracking, and other project support, is also required.

How You Will Achieve It
  • Manage relevant healthcare compliance processes, requirements, and systems to establish best practice and support R&D colleague compliance with Pfizer policy and applicable laws and regulations.
  • Analyze activity trends and transactional data to ensure systems optimally support R&D processes and maintain compliance with applicable policies.
  • Provide project management oversight of designated vendors on system design projects and other enhancement projects or initiatives.
  • Develop an informed and effective communication and training plan to educate R&D colleagues on healthcare compliance processes, compliance requirements, and support provided by R&D Compliance Operations, including drafting and development of communication and training materials.
  • Provide timely, actionable guidance and client support as a process subject matter expert (SME) to address process questions from users and to develop materials to support issue management.
  • Identify external environment best practices to develop proactive continuous improvement goals that deliver measurable value to Pfizer.
  • Assist with the development and ongoing maintenance of SOPs, work instructions, and auditable documents and create work instructions to maintain a consistent and efficient operational model.
  • Conduct transactional monitoring and report on all remedial or corrective actions to identify trends and to drive continual improvement.
  • Work across R&D units/partner lines and country stakeholders to share best practices.
  • Support Corporate Audit activities as needed.


Qualifications

Must-Have
  • Bachelor's degree and 5+ years' experience
  • Demonstrated organizational and project management skills
  • Demonstrated strength in analytical skills and attention to detail
  • Good understanding of audit frameworks that apply to R&D activities
  • Able to take action on quality and compliance metrics and trends
  • Ability to manage multiple complex projects and has business acumen
  • Excellent interpersonal effectiveness and written and verbal communication skills
  • Demonstrated success distilling complex information and communicating clear, actionable recommendations
  • Demonstrated ability to manage vendors to ensure effective project delivery


Nice-to-Have
  • Master's degree
  • Experience in quality control and/or quality assurance within the pharmaceutical industry
  • Knowledge of training design and tools, and experience in applying training methodology


Other Job Details:
  • Work Location:On Premise / Hybrid
  • This is an individual contributor role
  • Last date to apply is April 22, 2024


The annual base salary for this position ranges from $93,500.00 to $155,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 12.5% 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.

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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