Preclinical Compliance Analyst, Preclinical Sciences & Translational Safety (PSTS)

Company: Disability Solutions
Location: Spring House
Posted on: November 1, 2024

Job Description:

Johnson and Johnson is recruiting for a Preclinical Compliance Analyst, Preclinical Sciences & Translational Safety (PSTS) to be located in Spring House, PA.\rAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.\rFor more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.\rWe know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.\rAt Johnson & Johnson, we all belong.\rThe Preclinical Compliance Team is responsible for the development, maintenance and execution of compliance strategies and programs for non-GXP and GXP Discovery and Preclinical development work. This requires enabling fit for purpose processes and tools and facilitating the right organizational culture, through close collaboration with functions and partners, in order to ensure reconstructable and trustworthy data that supports internal decisions and external scrutiny.\rThe team manages 5 Compliance programs: (1) Compliance Strategy, (2) Onboarding, Training and Knowledge Management, (3) Procedures, Tools and Documents, (4) Data and Materials Transfer and Archiving, and (5) Compliance Status. The team is accountable for Controlled Substances Compliance oversight and also handles inspection readiness programs and inspection support as well as tactical and operational compliance support for the PSTS organization.The Preclinical Compliance Analyst, PSTS performs tasks and assists with tactical execution of projects and processes in support of the 5 Compliance programs within PSTS.\rKey Responsibilities:

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• Support the establishment and execution of appropriate quality and compliance programs for non-GXP and GXP Discovery and Preclinical development work, according to the J&J quality management framework, external regulations/expectations and Discovery, Product Development, & Supply (DPDS) vision and mission.
• Collaborate with partners in PSTS functions and other R&D teams.
• Contribute to established priorities and harmonized business practices to improve the contributions of the Preclinical Compliance team to the functions.
• Support operational excellence including implementing best methods and procedures.
• Support due diligence outcomes and L&A integration activities.\r\r

Keywords: Disability Solutions, Baltimore , Preclinical Compliance Analyst, Preclinical Sciences & Translational Safety (PSTS), Professions , Spring House, Maryland