Senior Associate, Trial Disclosure

About the role

Purpose

Describe the primary goals, objectives or functions or outputs of this position.

Leads the Institutional Animal Care and Use Committee (IACUC) program at the designated AbbVie site(s) to ensure compliance with all applicable regulatory oversight and accreditation agency expectations, including the United States Department of Agriculture (USDA) regulations/Animal Welfare Act (AWA), AAALAC International and, The Guide for the Care and Use of Laboratory Animals, as well as local oversight authorities by managing a progressive animal care and use oversight program.

Responsible for the management of a high-functioning animal care and use compliance program for all research animals used at the IACUC's designated site(s) to uphold AbbVie's commitment to maintaining an ethical biomedical research program and advancing our high standards for laboratory animal care and use.

Responsibilities

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• Responsible for management of the animal research program oversight process, ensuring regulatory compliance for AbbVie's animal care and use practices; oversees all aspects of a complex compliance program in accordance with regulatory requirements and institutional policies.
• Serves as the Institutional Animal Care and Use Committee (IACUC) Compliance Manager and a voting member of the IACUC.
• As a member of the IACUC Leadership team provide leadership by managing IACUC meetings, creating agendas, writing minutes, and developing annual goals to improve our compliance program and build a strong foundation for a sustainable culture of compliance and high standards for animal welfare. Maintain documentation of all IACUC communications including IACUC minutes, investigations, or other deliberations.
• Serve as an internal quality assurance for IACUC functions including audits for accurate tracking of animal numbers. Manager of the electronic IACUC management system, providing program support to the local CM and research staff.
• Key IACUC regulatory/compliance contact for local regulatory review, USDA inspections and/or AAALAC site assessments, including: Preparation of the IACUC portion of AAALAC Program Description, coordination of site visits; Maintaining USDA and/or local regulatory oversight readiness documents and preparation of annual report(s).
• Serve as a key contact for FDA audits, compiling required documents and maintaining accessibility for interview sessions.
• Monitors regulatory trends, communicates updates to leadership, and ensures compliance with new and evolving regulatory requirements through oversight of IACUC policies and procedures. Maintain schedule for the review and modification of such documents as required by federal mandates and as necessary to improve the functions of the IACUC process.
• The focal communicator about animal research compliance for the IACUC leadership, IACUC members, Institutional Official (IO), vet staff, safety, animal research staff, and CM training coordinator.
• Guide research staff in planning and preparation of protocols by maintaining a strong working knowledge of applicable animal welfare regulations & guidelines. Onboards new IACUC members and manages IACUC training of research staff & new Principal Investigators. Conduct continuing education for IACUC members and staff on IACUC policies and procedures as well as use of IACUC's electronic database.
• Manage the semiannual animal program evaluations and the animal facility inspections per USDA regulatory requirements. Document resolution of all noncompliance issues and manage regulatory documentation for the Institutional Official (IO), local regulatory authorities, USDA, and/or AAALAC.

Qualifications

List required and preferred qualifications (up to 10). Include education, skills and experience.

• A minimum of a Bachelor's Degree or certification(s) from training program(s) complimentary with this specialized area of animal research/compliance
• A minimum of 6 years in a laboratory animal related field, with 2 years experience in a compliance role.
• Strong oral and written communication skills
• Experience challenging the status quo and making unpopular decisions
• Proven experience in identifying key animal welfare and compliance issues, trends, and cause/effects as they impact the business while providing solutions to maintain compliance and reduce risk to the company
• Embrace the ideas of others and manage improvements to animal research compliance to implementation
• Must be able to work independently, perform multiple projects simultaneously, meet deadlines, and stay current with IACUC compliance trends as well as present about IACUC related topics at regional meetings
• Create a friendly environment that promotes compliance, remain flexible, and be open to suggestions for improvement to the program

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.