Clinical Pack & Label Outsourcing Lead
Location:
Hopewell Township , New Jersey
Posted:
January 31, 2017
Reference:
5972170112-en-us

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 liabilities

Qualifications
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


Primary Location
United States-New Jersey-Titusville
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Clinical Supplies

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

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