Sr Pr Scientist, Investigational Product Preparation Strategy
Johnson & Johnson UK
High Wycombe, United Kingdom
Investigational product preparation strategy
Cmc portfolio strategy
Patient safety
Lead activities related to the use of investigational products in clinical trials to ensure consistent program deliverables, including Investigational Product Preparation and Administration instructions (IPPI)
Job Summary
Lead activities related to the use of investigational products in clinical trials to ensure consistent program deliverables, including Investigational Product Preparation and Administration instructions (IPPI).
Ensure approaches are consistent with clinical site research pharmacy and nursing practice to ensure patient safety in compliance with applicable regulations and standards.
Provide consultation and expertise across J&J Innovative Medicine for the safe and accurate delivery of the portfolio at clinical sites, acting as the CMC point of contact for IP preparation and administration.
Matching Summary
Lead activities related to the use of investigational products in clinical trials to ensure consistent program deliverables, including Investigational Product Preparation and Administration instructions (IPPI).
Skills & Requirements
Must-have
Investigational Product Preparation Strategy
CMC Portfolio Strategy
patient safety
regulatory compliance
clinical site delivery
Nice-to-have
team development improvements
mentoring and coaching
multi-disciplinary environment
Key Requirements
Bachelor of Science in Nursing or Doctor of Pharmacy
10+ years patient care experience
Knowledge of USP requirements for investigational agents