Janssen Research & Development is recruiting an Associate Director- Dossier Operations Systems Lead located in Spring House, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.
We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
Associate Director- Dossier Operations Systems Lead provides guidance and direction to DDO regarding cutting edge technologies and their potential use in DDO to enhance efficiency and knowledge sharing. Participates effectively as part of a team in a global environment. Represents DDO or DPDS in teams that integrate systems affecting DDO or DPDS. Demonstrates a solid command of the technical tools needed to perform job duties and proficiency in standard desktop tools. Applies business related technologies to meet routine client needs. Highly regarded as expert problem solver for electronic tools and software applications. Possesses knowledge of the dossier planning and production process and standards as well as data management and visualization approaches. Has a general understanding of product development and organizational functions that contribute to the dossier production process. Demonstrates the analytical ability to define problems and interpret the information needed to drive resolution. Provides guidance to the Scientific Integrators on dossier construction and regulatory requirements concerning electronic submissions. Leads teams to continually improve DDO processes. May supervise 2-5 direct reports (CMC Dossier Specialist).
Job Scope/Span of Influence:
- Accountable for developing, executing and leading a DDO Systems strategy in cooperation with the DDO Operations Head, to drive the creation and maintenance of effective business tools to support all DDO operations.
- Represent DPDS and/or DDO on teams that preserve or enhance the document management systems (ERIS, DocSpace, Tru, etc.).
- Represent DPDS and/or DDO on teams concerning the use of, or enhancement of data management systems (Cognition Cockpit, SharePoint, Tableau, etc.).
- Represent the DPDS division on teams that define company processes, which involve ERIS, RIM, and related systems. Serve as Global ERIS Functional Lead (ERIS Champion) for the DPDS division.
- Represent DDO in development and implementation of visualization tools for planning, metrics, and decision making.
- Represent DDO in continuous improvement initiatives. Identify risks and guide mitigation efforts resulting from process improvement opportunities.
- Troubleshoot, define innovative workarounds, and document solutions to ERIS, Word, Excel, SharePoint, Tableau, and other software applications pertinent to the PDMS user community.
- Transform technical ideas, thoughts, and discussions into effective electronic tools. Define and optimize detailed workflows/processes that involve DDO processes.
- Write software enhancement requests for DDO. Perform administrator-level ERIS functions.
- Assures working relationships with consulting firms to assist in meeting J&J Pharma objectives.
- Bachelor’s degree with at least 8 years of relevant project management, system design management or equivalent experience is required
- Demonstrated success in design and implementation of project management tools, systems and processes in a matrix environment is required (e.g., SharePoint, Tableau, MS Project, Excel)
- Knowledge of dossier/document/knowledge management system development and management (eCTD, Documentum) is preferred. Knowledge of the dossier planning and production process and standards also preferred.
- General understanding of the pharmaceutical, medical device, or consumer product development, related regulatory requirements, and dossier/response creation and publishing is preferred
- Demonstrated success in people management and development is preferred.
- General understanding of product development and organizational functions that contribute to the dossier production process is required
- Experience with HTML coding and website development is preferred
This position is located in Spring House, PA.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-Pennsylvania-Spring House-
Janssen Research & Development, LLC (6084)