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Location: Cambridge, Massachusetts
Type: Full Time
Required Education: 4 Year Degree
Internal Number: 328550BR
6000! That’s the number of associates in the Novartis Institutes for BioMedical Research (NIBR). This division is the innovation engine of Novartis, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients.
Job Purpose:Lead regulatory compliance efforts at NIBR Cambridge through management of post approval monitoring program and significant engagement in IACUC ethical review processes. Global: provide key support to global AWC initiatives that span both internal and external animal activities.
Major Accountabilities:• Manage the day-to-day compliance operations for the local site Animal Welfare Compliance team:o Manage and evolve a collaborative Post Approval Monitoring (PAM) program to support scientists and ensure compliance with applicable regulatory standards and internal protocol, policy and training expectationso Identify and address process improvements and areas for innovation with scientific stakeholderso Provide regular PAM reports/updates to the Institutional Animal Care and Use Committee (IACUC)o Exemplify ethical use expectations and model leading practices for animal welfare including adoption of innovative 3Rs (reduce, refine, replace) strategies.o Liaise closely with IACUC, Comparative Medicine team and scientific staff to promote leading practices, facilitate compliance, build community and exhibit transparencyo Coordinate and direct semiannual facility inspectionso May be called upon to work with the IACUC to investigate questions of noncompliance• Manage IACUC policy portfolio throughout the lifecycle• Key contributor to IACUC administration including processing protocols and modifications, database tracking and meeting coordination• Support the local site’s Animal Welfare Training program in conjunction with cross-departmental colleagues (includes training material for new in vivo staff and continuing education programs for current in vivo staff)• Lead local 3Rs Working Group including meetings, ongoing activities within the in vivo community and annual events• Act as a contributing member of the global AWC team, interacting with and supporting colleagues on activities pertinent to exceptional animal welfare and ethics of animal use• Participate in global external research and supplier auditing process• Manage process for creation, review and implementation of global guidance documents• Sponsor/participate in communities of practice to support the remit of the Global Office of Animal Welfare Compliance, including staying current on animal welfare regulations, guidance, and best practices and sharing with local and global stakeholders• Assist in preparation of documents for regulatory agencies, including AAALAC Program Description and annual reports to regulatory authorities• Provide support during site visits and regulatory inspections
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Education:• Bachelor’s degree, or higher, in a scientific discipline (e.g. animal science, zoology, biology)• Certified Professional IACUC Administrator (CPIA) or eligibility to certify within 1 year.Experience:• 3+ years of experience relevant to the role or in managing a program of animal care and use• Experience in conducting in vivo technical procedures with small animal models in a discovery research setting• Experience working effectively with a team, as well as influential leadership and collaboration across teams in a matrixed environment is valuable• This position promotes independent thinking and requires self-sufficiency and decision-making skills