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Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Regulatory Science

Job Category:

Scientific/Technology

All Job Posting Locations:

Cincinnati, Ohio, United States of America

Job Description:

We are searching for the best talent for an Animal Welfare Compliance Specialist to be in in Cincinnati, OH.

#Li-Hybrid #LI-RP1

Purpose:

Acts as a highly trained individual contributor in the execution of operational plans within the preclinical group. Provides scientific/technical expertise in the preclinical space towards the preparation of regulatory submission information such as the program description for Association for the Assessment and Accreditation of Animal Care International (AAALACi) and the management of risk and opportunities. Provides requested input or functional contributions for health authority interactions such as the USDA during the annual unannounced regulatory inspections. Provides expertise towards the development of procedures and controls to ensure compliance with internal and external requirements, and to achieve quality and efficiency across the job function and interfacing job areas. Establish effective interfaces and relationships needed to be the point person for the MedTech Animal Care and Use Council. Responds to direction from management about new and changing regulations and necessary changes to own job area and drives implementation of such changes. Monitors proper recording of information and reviews information to draw appropriate conclusions. Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions.

You will be responsible for:

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

Serve as the IACUC chair

• Lead the Institutional Animal Care and Use Council (IACUC) review meetings for internal study protocols. Primary point of contact for the IACUC and semi-annual inspections.
• Work directly with IACUC members to develop IACUC policies and procedures and own IACUC related work instructions.
• Oversee animal protocol submission process and communication to IACUC members, Study Directors, and other Preclinical personnel.
• Oversee the maintenance of documentation pertaining to the IACUC Committee and its functions to ensure compliance with the United States Department of Agriculture (USDA) and AAALACi as well as J&J requirements.
• Recommend process improvements across Preclinical Research based on feedback provided by USDA, AAALACi, and internal audits.
• Serve as system administrator for electronic IACUC management system.
• Coordinate continued education and training for IACUC members.

Coordinate activities for the MD Animal Care and Use Council:

• Provide support for monthly Council meetings, including scheduling, developing agendas and presentations, capturing meeting minutes and distributing materials
• Manage the Council mailbox by responding to requests for information
• Develop and disseminate communications on the policy, including updates to SharePoint site
• Develop processes and tools for identification and tracking sites and auditing requirements to ensure compliance to policy
• Maintain policy training presentation, related communications and training assignments
• Maintain a list of stakeholders to receive communications and training assignments
• Maintain inventory list of external animal use sites, including responding to requests for a list of accepted sites and developing communication plans to J&J employees to ensure accuracy of site inventory list
• Support annual animal usage tracking through Laboratory Animal Tracking System (LATS) including validating the submission of data and conducting outreach and follow-up to ensure submissions across the sector
• Manage the assessment schedule (onsite and desktop) and support communications from the Council to external animal use sites and/or J&J employees from the mailbox
• Maintain standard operating procedures and accompanying forms created to support the implementation of the policy on behalf of the sector
• Develop presentations, as requested, on the status of the policy implementation
• Collect and manage documentation created and collected in support of the policy

Controlled Substance Coordinator

• Lead participant in the pharmacy team to dispense controlled substances for the Preclinical department
• Maintain inventory of controlled substances.
• Primary contact with Environmental Health and Safety for controlled substance disposable and access into the pharmacy.
• Maintain compliance with Drug Enforcement Administration (DEA) regulations.

Additional Regulatory Tasks

• Participating in Federal Drug Administration (FDA) inspections in the preclinical area
• In collaboration with the vivarium associate scientist, oversee the vivarium quality review for Good Laboratory Practice (GLP) studies.

General Business Tasks

• Responsible for communicating business-related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

Qualifications/Requirements:

• A minimum of a BS in biosciences with 5 years of experience animal research and project management experience.
• Knowledge and fluency in the use of project planning tools is required.
• Experience with leading multiple projects simultaneously and managing priorities is required.
• Ability to work both collaboratively as a team across various functions in a challenging and changing environment is required.
• Extensive knowledge of animal welfare and care regulations is required.
• Certified Professional IACUC Administrator (CPIA) certification is preferred.
• Experience and knowledge of GLP preferred.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

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