Preclinical Compliance Analyst, Preclinical Sciences & Translational Safety (PSTS) - Johnson and Johnson

Johnson and Johnson is recruiting for a Preclinical Compliance Analyst, Preclinical Sciences & Translational Safety (PSTS) to be located in Spring House, PA.

At 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/ .

For 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.

We 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.

At Johnson & Johnson, we all belong.

The 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.

The 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.

Key Responsibilities:

• 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.

Education:

• A minimum of a Bachelor's degree is required, preferably in Life Science or Natural Science. An advanced degree is preferred.

Experience and Skills:

• Strong analytical and problem-solving skills are required.
• Excellent oral and written communication skills are required
• Ability to work under time constraints, under supervision is required.
• Excellent organization skills, including scheduling, timely follow-up, and attention to detail are required.
• Outstanding diplomacy and negotiating skills are required.
• Ability to regularly read, understand, verify accuracy, and detail various written processes, Standard Operating Procedures, work instructions, etc. is required
• Compliance and ability to understand and apply applicable regulatory requirements as well as internal J&J expectations is required.
• Completion of all annual trainings are required.
• Adherence to all work safety standards are required.
• Ability to stay ahead of current trends and practices in field of expertise by completing required continuing education is required.
• Ability to manage different parallel tasks with a high level of accuracy is required
• Understanding of the overall process of drug discovery and development is preferred.

Other:

• Travel up to 10% may be required.
• Some "off-core business hours" meeting participation and work may be required.

This job posting is anticipated to close on 11/04/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .