Overview
Associate Director, Investigational Product Preparation Strategy at Johnson & Johnson Innovative Medicine. Located in Beerse, Belgium; Madrid, Spain; Paris, France; Sydney, Australia. This is a remote role available in all cities listed; applicants from any location are welcome.
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. Learn more at .
We are searching for the best talent for 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 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.
Role 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.
Education & Qualifications
A Bachelor of Science in Nursing, Doctor of Pharmacy, or international equivalent is requiredA 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 requiredExperience in implementing strategies for the safe and accurate delivery of investigational products in a clinical setting is requiredExtensive experience in the preparation and / or administration of both investigational and commercial agents is requiredExcellent communication skills, both oral and written, as well as proven conflict management and negotiation skills are requiredExcellent interpersonal skills with the ability to adapt effectively to a constantly evolving organization issues, structures and dynamics are requiredDemonstrated capability to manage multiple projects is requiredAbility to make difficult decisions in a timely fashion along with excellent follow through and organizational skills to assure team and organizational alignment to these decisions is requiredinfluencing ability without line authority is requiredActive clinical license as a nurse or pharmacist is requiredJohnson & 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 inclusive interview process. If you are an individual with a disability and would like to request an accommodation, please email
Other details
Seniority level : Not ApplicableEmployment type : Full-timeJob function : Product Management and MarketingIndustries : Pharmaceutical Manufacturing#J-18808-Ljbffr