Associate Director, Investigational Product Preparation Strategy

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 .

Purpose

Within the CMC Portfolio Strategy group, you will lead activities related to the use of investigational products in clinical trials to ensure consistent program deliverables, including the investigational product preparation and administration instructions (IPPI) across our diverse portfolio.

Responsibilities

• Create the IPPI to incorporate best practices for IP preparation and administration; identify opportunities to improve the process.
• Ensure approaches align with clinical site research pharmacy and nursing practice to guarantee patient safety and compliance with applicable regulations and international standards.
• Provide consultation and expertise across J&J Innovative Medicine; serve as the CMC point of contact for IP preparation and administration.
• Contribute to the CMC portfolio management team; track milestones for reporting to senior management.
• Seek opportunities for team or product development improvements across the TDS organization; support or lead initiatives to deliver organizational or process improvements.
• Demonstrate behaviors consistent with the current Leadership Imperatives; mentor and coach team members to improve skills and contributions in collaboration with line management.
• Work in a multi-disciplinary, complex, and innovative environment, delivering IP strategy and documents across Therapeutic Areas and the development process, including early, late, and LCM development.

Qualifications / Requirements

Education

A Bachelor of Science in Nursing, Doctor of Pharmacy, or international equivalent is required.

Required

• Minimum of 10 years recent experience in a patient care setting as a nurse or pharmacist with detailed knowledge of United States Pharmacopeia (USP) requirements for investigational agents.
• Experience implementing strategies for the safe and accurate delivery of investigational products in a clinical setting.
• Extensive experience in the preparation and / or administration of both investigational and commercial agents.
• Excellent communication skills, both oral and written; proven conflict management and negotiation skills.
• Excellent interpersonal skills with the ability to adapt effectively to a constantly evolving organization; ability to navigate issues, structures, and dynamics.
• Demonstrated capability to manage multiple projects.
• Ability to make difficult decisions in a timely fashion with excellent follow‑through and organizational skills to align team and organizational decisions.
• Influencing ability without line authority.
• Active clinical license as a nurse or pharmacist.

Equal Opportunity Employer

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 ( ) or contact AskGS to obtain your accommodation resource.

#J-18808-Ljbffr