Johnson & Johnson Careers

Manager, Regulatory Business Information Analyst

United States
Regulatory Affairs


Job Description

Requisition ID: 00001DEF

Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting for a Manager, Regulatory Business Information Analyst to be based in the United States or in Europe.


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.  

 

Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information.

 

The Regulatory Information Management Team is responsible for managing regulatory information globally, providing operational, people, and decision-making value via an enhanced user experience. Within RIM, the Content and Dossier Management (CDM) team oversees the regulatory capabilities required to manage and archive submission related documents and dossiers. The CDM team is leading the efforts to overhaul existing technology and transform the current way of working. In this role, the candidate would be responsible for helping to design the information flow within the new CDM tool(s) and from therein to related tools.


The Manager, Regulatory Information Analyst will serve as an expert resource supporting one or more areas, processes and technologies. Leads large, moderate to complex projects across Pharm or enterprise. He/She will manage relationships across global regulatory affairs and strategic partners, including, but not limited to R&D, IT, and commercial. This role will also work heavily with external technology partners.


Key responsibilities include:

  • The Manager, Regulatory Information Analyst will provide insight on availability, organization, connection, and blending of data. 
  • This individual will prepare extracts and integration of existing data as needed to support complex reports, visualizations, and modeling activities. 
  • He/she will bridge understanding of the data model between business and IT. 
  • This individual will organize information by translating user behavior into user information model design; crafting interactive experiences; producing workflow diagrams (and similar work products); preparing interaction specifications, navigation rules, organization of information, and site maps. 
  • This individual will identify opportunities for continuous improvement in the RIM Data ecosystem. 
  • He/she will partner with the business rules owner to ensure data rules are built into appropriate exchange layers. 
  • The Manager, Regulatory Information Analyst will provide training on the data model and available extracts to new users. 
  • This individual will understand how to run queries to pull data extracts, synthesize analyses, and interpret trends and variances.
  • He/She may also be asked to take on similar related projects across the RIM platform of tools as driven by the strategic need to have an end to end view of information.


Qualifications
  • A minimum of a Bachelor’s degree is required.
  • A minimum of 8 years of professional experience is required.
  • 6 years of experience in data modeling, data analysis, ETL, SQL querying, and/or using relevant analytics tools (Tableau, Cognos, SPSS, SAS, Alteryx, etc.) is required. 
  • Understanding of master data management principles and processes is preferred. 
  • Capacity management and/or portfolio management experience is preferred. 
  • Excellent partnering skills to foster collaboration across organizational boundaries is required. 
  • Deep understanding of word, templates, ribbons, Open XML is required.
  • Understanding of data and information standards and applicability of standards to solutions.
  • Knowledge and expertise in developing models to represent information/ data architecture, information flows and integrations.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.



Primary Location
United States--
Other Locations
Europe/Middle East/Africa
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Regulatory Affairs
Requisition ID
00001DEF