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Clinical Supply Specialist II / Clinical Supply Chain Manager

Company: United Therapeutics
Location: Silver Spring
Posted on: January 9, 2022

Job Description:

United Therapeutics is a vaccinated work environment where all employees are expected to be vaccinated against COVID-19 and provide proof of vaccination. We will provide any accommodations as required by law.The job details are as follows:What We DoUnited Therapeutics Corporation focuses on the strength of a balanced, value-creating biotechnology model. We are confident in our future thanks to our fundamental attributes, namely our commitment to quality and innovation, the power of our brands, our entrepreneurial culture and our bioinformatics leadership. We also believe that our determination to be responsible citizens - having a positive impact on patients, the environment and society - will sustain our success in the long term.We currently have five approved products on the market and a long-term mission of providing an unlimited supply of transplantable organs for those who need them.Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of "medicines for life". We continue to research and develop treatments for cardiovascular and pulmonary diseases, pediatric cancers and other orphan diseases.How you'll contribute as a Clinical Supply Specialist II
Support all aspects of Investigational Product manufacturing preparation, distribution, and reconciliation to ensure First-Patient-In (FPI) dates are met. Coordinate the packaging and labeling activities required to provide Investigational Product (IP) for clinical studies in time for scheduled First-Patient-In (FPI) date. Participate in the coordination of the IP returns and reconciliation process to provide for appropriate destruction of IP within a defined time period following the close-out of a study.

  • Assist with managing outsourcing activities with various contract vendors to develop project contract, packaging plans, batch records, and distribution strategies for all outsourced projects
  • Attend and participate in study-related meetings to build cross-functional relationships, gather information on study progress and share information on CTM status
  • Assist with the design of IRT (Interactive response technology) system, set-up, testing, and maintenance
  • Coordinate distribution of clinical supplies to approved investigational sites
  • Maintain accurate clinical supplies inventory and disposition documentation
  • Maintain clinical supply timelines, including responsibility for reporting timeline statuses to key internal and external stakeholder
  • Maintain current, accurate, and complete files of all study documentation related to CTM
  • Coordinate activities related to clinical supply packaging/labeling, logistics and disposition
  • Coordinate return, reconciliation, and destruction process of clinical trial materials
  • Coordinate stock recovery from clinical sites
  • Assist with preparing presentations for Investigator Meetings, CRA training, site initiations, or other related training situations
  • Assist with processing invoices from service contractors
  • Coordinate and document activities surrounding CTM complaints received from sites or vendor partners
  • Assist in preparation and maintenance of departmental SOPs, working practice documents (WPDs), and other procedural documentation
  • Perform other duties as assigned

    For this role you will needMinimum Requirements for a Clinical Supply Specialist II
    • Bachelor's Degree in Arts/Sciences (BA/BS)
    • 2+ years of direct clinical trial material experience in the Pharmaceutical industry with cGMP/GCP/ICH guidelines
    • Familiarity with cGMP/GCP/ICH guidelines
    • Highly organized and possess excellent attention to detail
    • Self-starter with strong oral, written, and interpersonal communication skills, as well as a proven ability to work in a team environment
    • Able to balance multiple tasks with varying priorities to meet timelines
    • Requires ability to recognize activities or events that may critically affect the availability of CTM or the conduct of clinical trials act on or pass that information to appropriate level of management
    • Maintain close working relationship with Manager allows for basic oversight of all activities
    • Proficient working in a PC/Window environment
    • Proficient with MS Office suitePreferred Qualifications for a Clinical Supply Specialist II
      • 2+ years of direct experience in Clinical Trial Management
      • IRT (Interactive Voice Technology) systemAt United Therapeutics, you'll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.

        How you'll contribute as a Clinical Supply Manager
        The Clinical Supply Chain Manager is responsible for planning and managing all aspects of clinical trial material (CTM) preparation, distribution & reconciliation as well as budget for CTM-related clinical trial costs. This role is responsible for multiple trials that may be domestic and/or international in scope and may be related to one or more clinical compounds.
        • Forecast, track, and manage clinical trial material manufacturing and supply chain, including raw materials coordination, and manufacturing operations packaging and labeling
        • Collaborate with Clinical Operations, Quality Systems and Compliance, and Regulatory Affairs departments for clinical trial material planning, forecasting, budgeting, and delivery
        • Attend and participate in study-related meetings to build cross-functional relationships, gather information on study progress and share information on CTM status
        • Manage outsourcing activities with various contract vendors to develop project contract, packaging plans, batch records, and distribution strategies for outsourced projects
        • Interface with Quality Assurance and CMC groups to support release of clinical supplies
        • Coordinate with Head of Clinical Supply and Data Management to design IRT (Interactive response technology) system, set-up, testing, and maintenance
        • Coordinate distribution of clinical supplies to approved investigational sites
        • Coordinate with CMC and Quality Assurance (QA) partners to manage technical and quality issues to facilitate uninterrupted supplies
        • Maintain accurate clinical supply inventory and disposition documentation
        • Maintain clinical supply timelines, including responsibility for reporting timeline statuses to key internal and external stakeholders
        • Maintain oversight of CTM study files (hard copy & electronic, as appropriate) to ensure they are kept current, accurate, and complete
        • Manage activities related to clinical supply packaging/labeling, logistics and disposition
        • Ensure uninterrupted supplies throughout the duration of clinical studies
        • Maintain/track inventory of available clinical supplies and tracks expiration dates
        • Manage return, reconciliation, and destruction process of clinical trial materials
        • Manage stock recovery from clinical sites
        • Prepare presentations for Investigator Meetings, CRA training, site initiations or other similar training situations
        • Manage activities to set a study CTM budget and assist with processing invoices from service contractors
        • Coordinate and document activities surrounding CTM complaints received from sites or vendor partners
        • Assist in preparation and maintenance of departmental SOPs, working practice documents (WPDs), and other procedural documentation
        • Perform other duties as assigned

          For this role you will needMinimum Requirements for Clinical Supply Manager
          • Bachelor's Degree in Arts/Sciences (BA/BS) in a related discipline
          • 8+ years of experience in the Biotechnology and/or pharmaceutical industry under cGMP/GCP/ICH guidelines
          • 4+ years of direct experience in clinical supply management
          • Experience with IRT (Interactive Response Technology) system
          • Knowledgeable of cGMP/GCP/ICH guidelines
          • Requires ability to recognize activities or events that may critically affect the availability of CTM or the conduct of clinical trials; acting on and/or passing that information to the appropriate level of management
          • Must be highly organized and possess excellent attention to detail
          • Must be a self-starter with strong oral, written, & interpersonal communication skills as well as a proven ability to work in a team environment
          • Requires juggling multiple tasks with varying priorities to meet timelines
          • Ability to perform under minimal supervision
          • Close communication and working relationship with manager to allow for oversight of all activities
          • Proficiency with MS Office Suite
          • Proficiency with PC/Windows environmentAt United Therapeutics, you'll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patientsUnited Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities

Keywords: United Therapeutics, Silver Spring , Clinical Supply Specialist II / Clinical Supply Chain Manager, Healthcare , Silver Spring, Maryland

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