Manager, Clinical Supplies

Job Locations US-NJ-Jersey City
ID
2018-1098
# of Openings
1
Category
Regulatory Affairs

Overview

Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.

 

Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We’re currently building a new commercial organization and expanding our other functions to support this strategy.

 

Manages the clinical supplies supply chain including activities focused on of approval and selection of contract packaging organizations, packaging and labeling operations and the reconciliation and destruction of clinical supplies materials. Accountable for effectively managing clinical supplies based on study timing, and in accordance with protocols, cGMP/GMP, ICH, FDA and any applicable federal and/or local laws and regulations and standard operating procedures.

Responsibilities

  • Drive the capability and feasibility assessment of contract packaging organizations
  • Coordinate functional and cross-functional activities within MTDA (CMC, Vendor Management, P&C, and Quality Assurance) to evaluate and approve contract packaging organizations
  • Coordinate the preparation and approval of Quality Agreements (QAG) between Quality Assurance and the contract packager, if not included in the Master Service Agreement (MSA)
  • Maintain list of current approved contract packagers
  • Confirm all agreements, including Confidential Disclosure Agreements (CDA), MSA, and QAG are current for all approved contract packagers
  • Notify appropriate parties within MTDA (CMC, Vendor Management, P&C, and Clinical Operations) when a contract packager has been removed from the list of approved contract packagers
  • Participate in development of Clinical Supply Plans
  • Initiate requests for the manufacture of CTM at the contract packager
  • Track and report current clinical supplies activities by contract packager and study
  • Develop and implement label strategy and process based on trial requirements in consultation with Clinical Science and CMC
  • Create and finalize packaging/labeling production schedules and identify and resolve any discrepancies/issues with Project Manager
  • Track the reconciliation, disposition, and destruction of all clinical supplies materials and related communications and reports
  • Create/participate in developing, implementing, and harmonizing clinical supplies related standard operating procedures and policies
  • Perform other departmental duties as assigned

Qualifications

  • Minimum BS/BA degree in life/health sciences/related field; or 5+ years of experience in clinical drug supply management

  • Minimum of 8 years experience, including a minimum of 5 years experience in labeling, packaging and distribution of clinical trial materials

  • Must have a proven track record in the management of labeling, packaging and distribution of materials to clinical sites
  • Must have experience in managing diverse project activities with manufacturing facilities at different geographical locations
  • Knowledge of FDA, ICH, GMP, GCP, and other regulatory requirements
  • Demonstrated knowledge of current pharmaceutical processes, packaging operations and drug development processes
  • Knowledge of clinical supply aspects of IND/NDA requirements; ability to present complex issues in oral and written form
  • Strong project management abilities.
  • Experience working in a multi-cultural, multi-lingual environment
  • Demonstrated ability to contribute successfully in a multi-disciplinary team environment / matrix organization
  • Competency in Windows, MS Office, Word, Excel, Power Point and other related computer software (e.g., MS Project and Lotus Notes)

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