Pharmacy Investigational Product Specialist

  • Jornada Completa
  • Beerse
  • Publicado hace 1 semana

Janssen Pharmaceutica

We are currently looking for two Pharmacy Investigational (IP) Product Specialists (PIPS) who will serve as a key contact point between the sponsor and the investigational site (both commercial and non-commercial) for Investigational Product Preparation Instructions (IPPI) training of studies with a complex IP preparation process. In this role you will focus on IPPI review and training/implementation of IP preparation steps for all compounds deemed requiring training plans. You will be the key internal and external interface to ensure overall IPPI adherence. You will have the opportunity to contribute to continuous process improvement, training and mentoring for IPPI.

As a Pharmacy Investigational Product Specialist you may perform Site Managerand/or Trial Manager tasks as described in GCO procedural documents for ED&CP studies.

 Key Responsibilities:
  • Play a key role in the safe, efficient and effective IP preparation in clinical trials.
  • Review and provide input on IPPI, Site Investigational Product Procedures Manual (SIPPM), monitoring guidelines and all specific forms related to IP preparation and dosing before finalization as applicable.
  • Process risk assessment review where applicable.
  • Assist in site/pharmacy assessments, pre-trial site/pharmacy assessment activities and/or study feasibility assessments, providing recommendation from local area about site/investigator selection in collaboration with the trial team.
  • Close collaboration with the Drug Product Development (DPD) team and the Drug Preparation Administration Team (DPAT) around IPPI.
  • Attend primary DPAT kick off meeting as ad hoc member as needed.
  • Early connection with investigational site pharmacy and IP administration staff to review site IP process and equipment.
  • Close collaboration with GTL, SM, TM, Independent Drug Monitor (IDM) and Site Investigational Product Specialist (SIPS) for all IPPI related topics.
  • Evaluate and support process for IP and ancillary supplies/preparation kits are compatible with the pharmacy equipment/practice in the country/investigational site.
  • Review of site’s preparation and accountability records to ensure key information is captured and documented.
  • Review translation of IPPI and/or related documents into local language per policy and regulations.
  • Provide feedback on eCRF setup regarding IP preparation.
  • Collaboration on IP training material development with key stakeholders.
  • Attend key site initiation visits. Responsible for training of all versions of IPPI through dose escalation and preparation according to internal Standard Operating Procedures (SOPs)/Work Instructions (WIs)/Instructions for Use (IFUs) and policies.  Support IP issue resolution and work closely together with the IDM to ensure site training for blinded trials.
  • Set up and attend mock runs on IPPI preparation before first formal IP preparation at the investigational site if applicable.
  • Observe first IP preparation on site and/or support SM/IDM/SIPS if allowed according to local guidelines and blinding requirements.
  • Point of contact for the internal study team in the country for questions related to the IP preparation.
  • Review any modification of IPPI, SIPPM manual, specific forms related to IP preparation and dosing during the applicable phases of the trial.
  • Fully document trial related activities with respect to IPPI site training and monitoring (e.g. writing of visit reports and completion of follow-up letters to investigators). Documentation and escalation of major deviations and issues to appropriate stakeholders.  Ensure timely corrective actions are completed and documented.  Coordinate documentation with SM/IDM, as appropriate.
  • Lead and/or participate in special initiatives as assigned for IPPI and SIPPM development.
  • Establish and maintain good and productive working relationships with internal and external stakeholders (e.g. pharmacists, investigators…).

Qualifications

Candidate Requirements:

  • A degree in Pharmacy with 1-2 years of experience is required – A specialization in Hospital Pharmacy/Industrial Pharmacy is an asset.
  • A minimum of 2-3 years of clinical trial research experience is required.
  • Experience in monitoring Early Development and Clinical Pharmacology studies preferred.
  • Experience in Oncology and Immunology Therapeutic Areas strongly preferred.
  • Experience with biologics preferred.
  • Experience with IV infusions and SC or IM injections required.
  • Experience in clinical practice within hospitals/academic centers strongly preferred.
  • Strong knowledge of the drug development process, including International Council on Harmonization (ICH)/Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), local regulatory requirements, assigned protocols and associated protocol specific procedures, including monitoring guidelines, required.
  • Experience working with computer software applications required – experience in clinical systems would be an advantage.
  • Strong leadership, process initiative, influencing and mentoring skills.
  • Creative and flexible mindset with strong attention for details.
  • Excellent written and oral communication skills.
  • Proficient in speaking and writing the country language and English. Speaking an extra language (French, Spanish, German and/or Dutch) is an asset.
  • The ability to work at a fast pace within small exploratory study teams with accelerated cycle times is required.
  • The ability to work on multiple trials in parallel in different disease areas is required.
  • The ability to collaborate with all levels of management across a matrix organization is required.
  • Willingness to travel 50% (on a local and/or international level), approximately 2-3 days each week, with overnight stays, is required.
  • A valid Driver’s License.

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