Pfizer

IACUC Administrator Associate

Employer
Pfizer
Location
Groton, Connecticut
Salary
Competitive
Posted
July 16 2021
Ref
4805677
Discipline
Other, Other
Position Type
Full Time
Organization Type
Pharma
Why Patients Need You

Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.

What You Will Achieve

As part of the Comparative Medicine team, you will partner with the Site Head and Regulatory group in all aspects of IACUC administration and animal research compliance. The IACUC Administrator is expected to participate in all IACUC activities. This position requires project management activity, attention to detail, meeting deadlines, and the ability to interact professionally with various Pfizer colleagues. It is your hard work along with innovative ideas and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

Management of the IACUC review process:
  • Provide backup management and oversight of the animal use protocol review process using a web-based protocol tracking system for submission, IACUC review, and investigator communications.
  • This may include tracking of regulatory metrics, prepares reports/schedules, and communicates with others about the protocol review process.
  • Conduct initial administrative and technical screen of all protocols and use the professional knowledge and judgment to assess completeness and makes determination whether the protocol is compliant with institutional, local, state, and federal regulations/guidelines/policies.
  • Serve as the secondary contact for principal investigators for questions related to the protocol review process, system and/or questionnaire.
  • Provide system training to all users (investigators, IACUC members, vets, etc.) of the protocol management system.
  • Develop and manage SOPs/guidelines and propose changes to current practices and policies as appropriate.
  • Assist investigators in preparation of AUPs and/or responses to requests for revisions made by the IACUC, including advising investigators on the IACUC's expectations.


Oversight of all administrative responsibilities and activities of the IACUC:
  • Assist the IACUC Chair in the smooth and efficient operation of the site IACUC and related subcommittees, including scheduling of routine meetings, set agendas for meetings, etc.
  • Draft meeting minutes in a timely manner and forward them to key stakeholders before release.
  • Manage and participate in the semi-annual inspections and program reviews, including follow up on any noted deficiencies and preparation of draft reports to the institutional official and regulatory/accreditation agencies.


Regulatory Compliance:
  • Assist Site Head and Regulatory Compliance Lead in USDA, FDA, Corporate Audits and AAALAC inspections/site visits as requested.
  • Serve as a resource to investigators, colleagues, IACUC members and staff on AUP/regulatory inquiries for the use of animals in research.
  • Manage all confidential agreements/documentation related to regulatory compliance.
  • Adhere to Pfizer and departmental safety policies and departmental SOPs and guidelines.
  • Coordinate and assist with training programs to promote awareness of developments in the regulatory environment.
  • Assist in the investigations of animal welfare concerns as needed.
  • Provide support to the post-approval monitoring program; including scheduling, coordinating, participating in, documenting, and ensuring follow up on all PAM activities.
  • May be required to work under one of the following: The United States Department of Agriculture Animal Welfare Act and associated Regulations and Standards, the Guide for the Care and Use of Laboratory Animals, Good Laboratory Practices, Public Health Service Policy and/or AAALAC accreditation standards.


Qualifications

Must-Have
  • BS/BA degree required.
  • 3-4 years related experience, including experience in the use of animals in research, teaching, and testing.
  • Must possess excellent organizational, interpersonal and communications skills as well as sensitivity to handling confidential information.
  • Must be detailed oriented, flexible and possess the ability to work under pressure.
  • Must be a quick learner able to set priorities by handling multiple tasks simultaneously.


Nice-to-Have
  • CPIA certification preferred.
  • Clear understanding of the regulatory guidance (e.g., USDA, AAALAC, etc.) that may impact administrative functions.
  • Completes recurring assignments independently and selects the most appropriate method or approached to do so within prescribed limits of authority.
  • Refers only to new or unusual problems to supervisor and work is only reviewed periodically for soundness.
  • Uses diplomacy to resolve problems.


Other Job Details:
  • Eligible for Employee Referral Bonus: YES


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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.

Research and Development

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