Associate Director, Investigational Product Preparation Strategy
We are seeking an Associate Director, Investigational Product Preparation and Strategy to be located in Beerse (Belgium), Madrid (Spain), Paris (France), or Sydney (Australia). This is a remote role available in all cities. While specific cities are listed for reference, they do not limit your application. We invite candidates from any location to apply.
Overview
Within the CMC Portfolio Strategy group, you will lead activities related to the 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.
Responsibilities
* Create the IPPI to ensure best practices for IP preparation and administration are incorporated in our processes and identify opportunities to improve the process.
* Ensure 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.
* Provide consultation and lend expertise across J&J Innovative Medicine to ensure the safe and accurate delivery of our portfolio at clinical sites and serve as the CMC point of contact for IP preparation and administration.
* Contribute to the CMC portfolio management team by tracking milestones for reporting to senior management.
* Identify opportunities for team or product development improvements across the TDS organization and support or lead initiatives to deliver organizational or process improvements.
* Demonstrate leadership behaviors, mentor and coach team members 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 life-cycle management development.
Qualifications / Requirements
* Bachelor of Science in Nursing, Doctor of Pharmacy, or international equivalent 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.
* Experience in 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, and proven conflict management and negotiation skills.
* Excellent interpersonal skills with the ability to adapt to a constantly evolving organization.
* Demonstrated ability to manage multiple projects.
* Ability to make difficult decisions in a timely fashion with strong follow-through and organizational skills to align teams and the organization with these decisions.
* Influencing ability without direct line authority.
* Active clinical license as a nurse or pharmacist.
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. If you require accommodations during the application process, please contact the appropriate resource per company policy.
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