Pharmacy Investigational Product Specialist (PIPS) (M/F)
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen!
We are seeking a Pharmacy Investigational Product Specialist (PIPS) to serve as subject matter expert for pharmacy preparation in the field of early development clinical research. You will focus on the process and instructions for preparing and administering investigational drugs as per the Investigational Product Preparation and Administration Instructions (IPPI).
The head office is in Issy Les Moulineaux, France and this position is home-based reporting to the Global Head of IPPI Team.
The PIPS contributes to the IPPI by offering strategic insights and helping create the IPPI document. They also create training materials, decide on training methods, and train internal staff. The PIPS advises on ancillary supply selection, study feasibility, and mentors for IPPI. They ensure IPPI follows rules, manage risks, and assist in quality investigations.
You will be part of a hardworking, enthusiastic, and committed global team, eager to deliver and helping to improve the lives of millions of patients!
Are you ready to join our team? Then read further!
- Be responsible for training of preparation process for all versions of the IPPI according to internal Standard Operating Procedures (SOPs)/Work Instructions (Wis) and policies for internal staff.
- Provide recommendation to Global Trial Lead (GTL) on training strategy /methodology for IP preparation as well as evaluate additional internal team training needs such as Just In Time training related to site practice, ancillary supplies, process.
- Support Site Manager (SM) if needed during first dose according to local guidelines and blinding requirements.
- Ensure compliance oversight on IPPI related issues, mitigation of risks, escalation of major deviations and issues to appropriate partners, quarterly trending reviews and provide expertise during quality investigations.
- Provide input on study-specific Major Protocol Deviation (MPD) criteria and major issue list related to IPPI.
- Provide IWRS dosing requirements to Randomization and Trial Supply Management Manager (RTSM manager) and review and sign final RTSM system specifications.
- Take the lead in IPPI related initiatives and working groups.
- Establish and maintain good and productive working relationships with external stakeholders (e.g. pharmacists, investigators) and internal (GTL, CTM, SM, LTM, IDM, GDM, SRP, IPPI Liaison, and SIPS) for questions and issue resolution.
- Provide insights to internal teams regarding processes and procedures as communicated by clinical sites/local regulations.
- Consistently maintain a diverse portfolio of advanced and highly complex studies and share insights and strategies with various internal teams to include GD colleagues, DPAT teams, special project teams.
- Seek to understand study site perspective by approaching each interaction as an opportunity to build and strengthen relationships as well as gather site practice intelligence.
- Provide leadership to new employees; leading and/or assisting in on-boarding, observational experiences, IPPI educational workshops and provides mentorship.
- Present data and information in a manner appropriate to the audience, identifying groups that would benefit from presentations and information.
- Actively participate in IPPI and all other pharmacy practice and scientific discussions.
- Knowledge of best practices on preparation of parenteral products; monitor and integrate evolving trends in pharmacy practice into current and future IPPIs.
- Perform all administrative requirements in a timely, correct and accurate manner (e.g. expense reports, documentation of activities, vTMF filing, CTL&D upload, TruVault Production uploads and approvals).
- Ability to handle and solve problems and difficult clinical scenarios.
Education and Experience Requirements:
A degree in hospital Pharmacy with 4 or more years of experience in a hospital or clinic required.
Extensive experience with compounding is required, including various ways of drug preparation such as IV infusions, Subcutaneous infusion etc.
Experience in Oncology (hematology and solid tumor) and Immunology Therapeutic area strongly preferred.
Hands on clinical trial research experience at site level, preferable in Early Development.
Extensive knowledge on IP preparation related requirements (sterile vs aseptic technique, biosafety cabinets, air control, etc.) required.
Solid understanding of IP specifications (stability, compatibility, safety data) required.
Knowledge on Ancillary Supplies used for IP preparation, including new kind of devices (closed system transfer devices, needle-less devices), materials of construction, hold-up volumes required.
Experience in training health care providers, to include identification of key needs, assessment, development, and execution of training material strongly preferred.
Knowledge on local and regional regulatory requirements for pharmacy practice, including USP, Eudralex, GMO or other applicable standards, strongly preferred.
Must be proficient in speaking and writing French and English.
Current & Sound Scientific competence preferred.
Knowledge of the drug development process and on International Council on Harmonization (ICH)/Good Clinical Practices (GCP) is an asset.
Strong leadership, process initiative, influencing and mentoring skills.
Experience working with computer software applications and clinical systems.
Innovative and creative with strong attention for details. Problem solving skills with ability to make decisions.
Good written and oral, interpersonal communication skills.
Self-motivated; entrepreneurial thinker, flexible, able to adjust to a variety of diverse and sometimes challenging situations. The ability to multitask, work on multiple trials in parallel in different disease areas.
Able to effectively collaborate with all levels of management across a matrix organization.
Willingness to travel up to 10% (on a local and/or international level) with overnight stays on occasion. A current and valid Driver’s License.
We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our organization.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.