Clinical Supply Manager
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .
As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
R&D OperationsJob Sub Function:
Clinical Supply OperationsJob Category:
ProfessionalAll Job Posting Locations:
Shanghai ChinaJob Description:
General mission
The Clinical Supply Manager is responsible for project planning and scheduling across internal stakeholders including Clinical Operations Supply Chain Quality and related functions as well as external stakeholders such as clinical sites and CMOs. This role serves as the primary point of contact for Clinical Operations and CMC activities supporting advanced therapy treatment scheduling and proactively coordinating and triaging technical and operational issues across the endtoend supply chain.
Specific missions
- Collaborates closely with the Clinical Operations team to understand sitespecific timelines for new site initiation and plans and leads logistical test runs between clinical sites CMOs and manufacturing (MFG).
- Provides site and studylevel training related to patient onboarding and all aspects of the clinical supply chain.
- Establishes and manages the supply chain network across the APAC region with a focus on advanced therapies; partners with local and global teams to ensure smooth timely delivery of clinical supplies.
- Coordinates and tracks the patient journey for identified clinical trial participants proactively triaging and resolving issues with appropriate stakeholders from subject screening through investigational product (IP) receipt at site.
- Participates in GCP and GMP health authority inspections. Have previous experience managing work with Contract Manufacturing Organizations to perform capability forecast
- Ensures ongoing compliance with all company policies procedures and applicable regulatory requirements.
Profile needed for this function
Knowledge
- Excellent verbal and written communication skills with the ability to effectively engage and influence both internal and external stakeholders.
- Proven ability to work effectively in a multicultural global environment.
- Demonstrated ability to collaborate crossfunctionally and externally to build strong partnerships with key stakeholders and service providers; skilled in identifying gaps determining root causes and developing innovative practical solutions.
- Strong operational and execution skills with a high sense of urgency and a solutionoriented mindset.
- Knowledge and understanding of clinical study requirements and clinical operations preferred.
- General knowledge and understanding of GxP principles.
Degree
Masters degree or above in a pharmaceutical clinical or related discipline along with 8 years of relevant experience; clinical supply chain management experience is strongly preferred.
Languages
- Local English
Specific know how of systems
- Intermediate to advanced software skills (e.g. Microsoft Excel PowerPoint) is required.
- Experience with SAP Ariba and/or RTSM (IWRS) functionality is an advantage.
Required Skills:
Preferred Skills:
Clinical Supply Chain Clinical Trial Protocols Coaching Critical Thinking Financial Competence Good Manufacturing Practices (GMP) Inventory Optimization Laboratory Operations Organizing Process Improvements Procurement Policies Program Management Research and Development Stakeholder Engagement Stakeholder Management Standard Operating Procedure (SOP) Technical CredibilityRequired Experience:
Manager
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more