Johnson & Johnson
BE - Clinical Project Specialist
Your responsibilities and your Impact:
You are responsible for the management of clinical supplies (Drug Product and Finished Kits) during all phases of clinical trials consistent with Good Manufacturing,
Distribution, and Clinical Practices (i.e. GxP guidelines), with a specific focus on Temperature Management & Control (TM&C).
Manage and prioritize temperature excursion submissions and other temperature related requests in the shared shared mailbox.
Develop strong internal collaboration with Global Development, Drug Product Development, Analytical Development, Quality, Trial & Supply Management, Clinical Supply Integration, and
Logistics stakeholders to ensure temperature excursions resolution and overall customer satisfaction
Customize protocol specific temperature out-of-range (TOR) forms based on product attributes
Coordinate quote request and purchase order setup process to centrally source temperature monitoring devices
Support business process improvement initiatives
Support changes to the portfolio like new trials, products, and integrations
Identify opportunities for further integration with Logistics and if needed, support the Logistics
Quality Events (i.e. QI) process, with a focus on issues related to Temperature excursions
Experience Required for Role
2-4 years of professional related business experience, preferably in a clinical supply related role (i.e. operations, logistics, quality, planning, development)
Knowledge of Clinical Supply Distribution, Clinical Study Execution, and GxP principles
Highly organized with strong attention to detail
Acute sense of urgency for the tasks at hand, including ability to drive resolution with minimal management oversight
Ability to work effectively in a dynamic environment, handle multiple projects, and daily planned and unplanned operational activities
Excellent written and verbal communication skills
Workflow / Process oriented - stress resilient
English fluent written and spoken
A minimum of a university/bachelor’s degree (or equivalent experience) is required
Other preferred skills:
Strong critical thinking skills
Strong cross-functional coordination skills
Excellent problem solving and decision-making skills
Strong quality management skills
Requires MS Office proficiency, specifically advanced Microsoft Excel skills
Strong data analysis and problem-solving experience (e.g. use of Excel to analyze large sets of data via pivot tables, graphs, VLOOKUP, etc. to influence decision-making)
Business applications experience is an advantage, such as SAP Ariba, Quality Event Management System (i.e. Trackwise), and/or Interactive Response Technology (i.e. IVRS) functionality
Things to remember before applying for this role:
We are looking to process the first round of applications within the next 2 working days.
We do not accept applications via email.
If you are interested in this role please apply now! Make sure you fill out your application in full, your personal CV will be used for the recruiter’s reference only, they are not sent to Hiring Managers. Ensure all relevant information is included in your application!
Thank you very much and we look forward to receiving your application.
If you would like some additional information about the role please contact: firstname.lastname@example.org (please note that we do not accept applications via email).
Diversity, Equity & Inclusion:
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences
That is why we in Belgium are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.