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General Mission

The Clinical Supply Associate will manage clinical supplies for clinical trial execution in Asia-Pacific region. He/she will be responsible for project planning and scheduling between internal stakeholders (clinical operation, supply chain, quality, et.al) and external stakeholders (clinical sites & CMOs). The Clinical Supply Associate will be the point of contact for Clinical Operations and CMC activities related to advanced therapy treatment scheduling & triaging technical/operational issues during the whole chain. This position will be based in Shanghai, China.

Specific Missions

• Close coordination with Clinical Operation team to understand site-based timings for new site initiations, planning, and leading of logistical test runs between Clinical Sites, CMO & MFG.
• Provides site and study level training related to patient onboarding and all aspects of supply chain.
• Set up the supply chain network across APAC region with a focus on advanced therapy. Work closely with local/global teams to ensure the smooth and on-time delivery of supplies.
• For patients identified for participation in a clinical trial, coordinates & tracks the patient journey, triaging any issues to appropriate stakeholders between subject screening & IP receipt on site.
• Participates in GCP and GMP health authority inspections. Have previous experience managing work with Contract Manufacturing Organizations to perform capability forecast and assessments, and provide expertise to influence and bridge gap analysis to meet Clinical Trial requirements.

Profile Needed for This Function

Knowledge
• Requires general supply chain managment experience in phamacieutical company with excellent project management and communication skills. Experience with clinical trial operations, pharma/biotech R& D is preferred.
• Demonstrate ability and experience to work in a highly regulated environment (HA/J& J standards and guidelines, general GCP/GMP guidelines) is required.
• With some guidance, responsible for any tech support/use resolution at those internal or external stakeholders.
• Supports proactively in the continuous improvement of the overall supply chain processes.
• The ability to work in a multi-country/cultural environment (across geographic regions) is essential.

Degree
• A master’s degree or equivalent desired, preferably in medical, biopharmaceutical related majors with at least 5 years of working experience.

Languages
• English (Fluent in spoken and written)
• Japanese/Korean desired

Specific Know-how of Systems
• General knowledge of GxP principles
• Excellent written and verbal communication skills, able to communicate clearly, making the complex clear and compelling to all levels of the organization in both written & oral forms are required.
• Ability to effectively apply project management tools to lead projects and programs is required.
• Good at MS Office applications and willing to learn and support new clinical systems development.