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 at https://www.jnj.com

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Biotherapeutics R&D

Job Category:

Scientific/Technology

All Job Posting Locations:

Cambridge, Massachusetts, United States of America, Malvern, Pennsylvania, United States of America, Raritan, New Jersey, United States of America

Job Description:

About Innovative Medicine:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for an Associate Director, Investigational Product Preparation and Strategy.

Beerse, Belgium - Requisition Number: R-016743 Associate Director, Investigational Product Preparation and Strategy.

This is a remote role available in all cities within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

Remote work options may be considered on a case-by-case basis and if approved by the Company.

Purpose:

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

You will be responsible for:

• creating the IPPI to ensure that best practices for IP preparation and administration are incorporated in our processes and look for opportunities to improve the process.
• ensuring our approaches are consistent with clinical site research pharmacy and nursing practice to ensure patient safety in compliance with applicable regulations, international standards, good clinical practices, and institutional policies and procedures.
• providing consultation and lend expertise across J&J Innovative Medicine to ensure the safe and accurate delivery of our portfolio at clinical sites and will be the CMC point of contact for IP preparation and administration.
• contributing to the CMC portfolio management team tracking milestones for reporting to senior management.
• seeking opportunities for team or product development improvements across the TDS organization. You may also support or lead teams in implementing initiatives to deliver organizational or process improvements.
• demonstrating behaviors consistent with the current Leadership Imperatives and will be mentoring and coaching team member to improve their skills and contributions to the organization in collaboration with line management.
• working 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:

• A 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 is required
• Experience in implementing strategies for the safe and accurate delivery of investigational products in a clinical setting is required
• Extensive experience in the preparation and/or administration of both investigational and commercial agents is required
• Excellent