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Manager, Dictionary Management

Company: J&J Family of Companies
Location: Spring House
Posted on: February 16, 2020

Job Description:

Janssen Research & Development, LLC, a member of the J&J Familyof Companies, is recruiting for a Manager, Dictionary Management (DM) to work in Spring house, PA., Horsham, PA., Fort Washington, PA., Raritan,NJ., or Skillman, NJ. Janssen Research & Development, L.L.C. develops treatments thatimprove the health and lifestyles of people worldwide. Research and developmentareas encompass novel targets in neurologic disorders, gastroenterology,oncology, infectious disease, diabetes, hematology, metabolic disorders,immunologic disorders, and reproductive medicine.The Manager, Dictionary Management (DM) will work with key businessrepresentatives across all sectors and the Director of Standard Terminologiesand Analytical Reporting to define and implement product configurationstandards within the global safety database (GSD) and to ensure the DictionaryManagement (DM) group maintains these standards during all operationalactivities. The Manager, Dictionary Management will also lead operationalprocesses involving incorporating source data, external to GSD or GMO, that isrequired for product and library list configuration and maintenance activitieswithin the global safety database. The role will also develop and maintain DMoperational metrics. The Manager, Dictionary Management will also be expectedto represent DM on cross-functional projects.

  • Define, develop and maintain product configuration standards within theglobal safety database that meet business requirements for different producttypes within each sector
  • Develop processes and efficiencies for product and library listconfiguration within the global safety database where external GMO sources arerequired for that initial configuration and ongoing maintenance
  • Lead strategist and primary point of contact for other functionalgroups seeking assistance regarding database searches requiring productconfiguration input
  • Develop and manage operational metrics for the Dictionary ManagementTeam
  • Lead CAPA resolution process for DM
  • Interface with internal and external stakeholders and manage DMdeliverables related to Product and Library List configuration and maintenance
  • DM Lead on local and international multidisciplinary functional teamsrequiring information related to Product and Library List configuration andmaintenance
  • Lead internal and external audit and inspection activities forDictionary Management related to Product and Library List configuration andmaintenance
  • Lead strategist for the development of any future automation processesrelated to the maintenance of the company product dictionary, other medicaldictionaries, or library lists used within the global safety database.
  • Lead strategist for any future enhancements within the current globalsafety database which improves efficiencies related to any DM processes.
  • Configuration standards for different product types across sectorswithin the Company Product Dictionary
  • Any automated processes developed regarding product dictionary orlibrary list configurationQualifications
    • BA or BS degree in Computer or Life Sciences related field strongly preferred
    • Project Management Certification preferred
    • 8 or more years of experience in the pharmaceutical industry and/or healthcare industry required
    • Extensive knowledge of Drug Dictionaries and product master data, preferably in a Drug Safety environment required
    • Experience with Aris G safety system preferred
    • Practical knowledge of applicable global, regional and local regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
    • Previous pharmaceutical experience and understanding of safety regulations, required
    • Basic Knowledge of medical terminology and Medical Dictionaries (MedDRA and Who Drug)
    • Strong project management experience preferred
    • Ability to coordinate and harmonize workflow activities of the team, evaluate processes and suggest ways to improve efficiency, accuracy and compliance
    • Ability to work independently to investigate and resolve technical or data issues
    • Strong verbal and written communication skills
    • Strong presentation skills to fit target audience and key stakeholders
    • Ability to effectively multi-task and effectively manage competing priorities and meet strict deadlines
    • Clear and concise documentation skills
    • Intermediate to advanced skills in the MS Office Suite
    • Experience in high volume work environment
    • Alternative working locations: Spring house,PA., Horsham, PA., Fort Washington, PA., Raritan, NJ. or Skillman, NJ. Johnson & Johnson is an Affirmative Action and EqualOpportunity Employer. All qualified applicants will receive consideration foremployment without regard to race, color, religion, sex, sexual orientation,gender identity, age, national origin, or protected veteran status and will notbe discriminated against on the basis of disability.Primary LocationUnited States-Pennsylvania-Spring House-Other LocationsNorth America-United States-Pennsylvania-Fort Washington, North America-United States-Pennsylvania-Horsham, North America-United States-New Jersey-Raritan, North America-United States-New Jersey-SkillmanOrganizationJanssen Research & Development, LLC (6084)Job FunctionR&DRequisition ID3634200103

Keywords: J&J Family of Companies, Philadelphia , Manager, Dictionary Management, Executive , Spring House, Pennsylvania

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