Janssen Research and Development, LLC, a member of the Johnson and Johnson Family of Companies, is recruiting for a Clinical Pack & Label Outsourcing Lead to be located in Titusville, NJ.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Clinical Pack & Label (P & L) Outsourcing Lead will be responsible for the day to day management of their outsourced packaging and labelling orders. The coordinator should have a good understanding of drug product development process and operating company products. The coordinator will have an in-depth understanding of P & L operations (internal or external) and be able to utilize this knowledge to ensure cGMP-compliance in the production facilities for packaging and labeling. The coordinator will help manage the P & L outsourcing organizations’ strategy of “just in time labelling” to allow late stage customizations. Provides outsourcing input for the overall study with complex and changing circumstances and understands project management. The coordinator will participate in TT meetings to maintain fast flexible execution of packaging orders. Works cross functionally to implement the P & L sourcing strategy in a global environment ensuring seamless technology transfer of pack & label processes from CSC P&L internal to external partners. The coordinator will initiate and manage events and investigations.
The Clinical Pack & Label Outsourcing Lead activities include, but are not limited to the following:
• Responsible for day to day management of outsourced packaging and labeling orders
• Supports and may lead the implementation of strategic plans in line with the organizations vision mission and goals, seeks opportunities to learn how to apply strategies in daily activities
• Communication of internal requirements to external partners, follows-up on testing and documentation to support clinical pack & label operations following regulatory and GMP requirements
• Initiates and facilitates communication between functional team members.
• Communicates effectively across the organization in a clear, concise, accurate, and grammatically correct manner; uses appropriate language and tone; tailors information to meet the needs of the audience
• Responsible for day to day activities to support On-Time-Delivery (OTD).
• Initiating purchase orders and following up on invoice reconciliation.
• Works with others to identify appropriate stakeholders and builds relationships that are mutually beneficial with individuals from other departments and functions
• Participates and may lead assigned projects, completes assignments, identifies and adjusts project plans, meets deadlines
• Identifies risks and determines benefits and liabilitiesQualifications
• A Bachelor’s degree is required
• A degree in pharmacy, supply chain, mechanical or chemical engineering or closely related discipline and/ or an advanced degree are preferred
• A minimum of five (5) years of related work experience in the pharmaceutical industry is required
• Written, verbal and presentation skills with experience in working with cross-functional teams are required
• Experience with outsourcing and contract oversight, experience managing P&L budgets at a trial or compound level is preferred
• Excellent project management skills are preferred
• Experience with process development, launch and implementation of global clinical supplies systems are preferred
• Excellent time management, priority setting and communications skills
• Position is located in Titusville, NJ and may require up to 15% domestic and/or international travel
United States-New Jersey-TitusvilleOrganization
Janssen Research & Development, LLC. (6084)Job Function