Associate Director, Investigational Product Preparation and 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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

• Leading a cross-functional team accountable for creating the IPPI to ensure that best practices for Investigational Product (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.
  

• A bachelor’s degree in nursing, a Doctor of Pharmacy/PharmD, or international equivalent is required; Active clinical license as a nurse or pharmacist is required             
• 10+ years’ 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 communication skills, both oral and written, as well as proven conflict management and negotiation skills are required
• Excellent interpersonal skills with the ability to adapt effectively to constantly evolving organization issues, structures and dynamics are required
• Demonstrated capability to manage multiple projects is required
• Ability 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 required
• Influencing ability without line authority is required

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 & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

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For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits