Manager Content and Dossier Management (Business Information Analyst) in Raritan, New Jersey | DiversityInc Careers
 

Manager Content and Dossier Management (Business Information Analyst)


Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting for a Manager Content and Dossier Management (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 systems capabilities required to manage and archive submission related documents and dossiers. The CDM team is leading the effort to deploy enhanced technology capabilities, to manage and archive global submission related documents and dossiers for our product portfolio lifecycle.   These enhanced capabilities will align to our regulatory activities and transform the current way of working.

 

The Manager, Regulatory Information Analyst will serve as an expert resource supporting one or more areas, processes and technologies. In this role, the manager will be responsible for understanding global customer requirements and translating those requirements into specific functional design options for new global capabilities.  He/she will lead analysis of use cases across regions, countries and business partners to understand the flow of information across our activities.  He/she will help document and design the CDM information flow within the new CDM tool(s), and the interfaces between related business tools.

 

The manager will consult with many stakeholders, in a global matrixed environment, including IT, the data standards team, commercial, and Janssen internal business partners.   This partnership will work collaboratively to assess and recommend solution design options.  He/she will also work hand in hand with the business to implement the solutions, once agreed to.  The manager will also be involved in the management and enhancements of the CDM capabilities once deployed.

   

The successful candidate must have the ability to lead large, complex projects across a global matrixed enterprise using a consultative approach. 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:
  • Identification and translation of customer requirements into technology and process flow design and tool functionality
  • Consulting and relationship management in a diverse global culture
  • Process and information flow documentation and analysis
  • Communication and global stakeholder relationship management
  • Managing external suppliers to meet deliverable based contracts
  • To provide business value driven solutions, he/she 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 content ecosystem. 
  • 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 6 years of professional experience is required.
  • Understanding of content and/or dossier management principles required
  • Practical experience preferred in conducting meetings, that drive towards business value creation, using methods that foster a creative, collaborative learning environment Business process experience, such as lean Six sigma a plus
  • Strong written and verbal communication skills
  • Understanding of master data management principles, tools 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 preferred.
  • Understanding of data and information standards and applicability of standards to solutions preferred.
  • Knowledge and expertise in developing models to represent information/ data architecture, information flows and integrations a plus


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-New Jersey-Raritan
Other Locations
Europe/Middle East/Africa, North America-United States
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Regulatory Affairs
Requisition ID
00001DQA