Sr Pr Scientist, Investigational Product Preparation Strategy

Johnson & Johnson Johnson & Johnson · Pharma · Beerse, Antwerp, Belgium +4

Senior Principal Scientist role focused on investigational product preparation strategy for clinical trials within Johnson & Johnson's Innovative Medicine division. The role involves creating and improving processes for safe and accurate administration of investigational products, ensuring compliance with regulations and best practices, and providing expertise across therapeutic areas. Requires extensive experience in patient care as a nurse or pharmacist with knowledge of USP requirements for investigational agents.

What you'd actually do

  1. 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.
  2. 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.
  3. 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.
  4. Contributing to the CMC portfolio management team tracking milestones for reporting to senior management.
  5. 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.

Skills

Required

  • Bachelor of Science in Nursing, Doctor of Pharmacy, or international equivalent
  • 10 years recent experience in a patient care setting as a nurse or pharmacist
  • 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
  • Proven conflict management and negotiation skills
  • Excellent interpersonal skills
  • Demonstrated capability to manage multiple projects
  • Ability to make difficult decisions in a timely fashion
  • Excellent follow through and organizational skills
  • Influencing ability without line authority
  • Active clinical license as a nurse or pharmacist

Nice to have

  • Analytical Reasoning
  • Biochemistry
  • Biotechnology
  • Chemistry, Manufacturing, and Control (CMC)
  • Clinical Research and Regulations
  • Clinical Trial Designs
  • Collaborating
  • Data Synthesis
  • Drug Discovery Development
  • Molecular Diagnostics
  • Pharmacovigilance
  • Process Improvements
  • Productivity Planning
  • Program Management
  • Scientific Research
  • Tactical Planning
  • Technical Credibility

What the JD emphasized

  • 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 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 a 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
  • Active clinical license as a nurse or pharmacist is required