Manager Content and Dossier Management (Business Information Analyst)

Janssen Research
& Development, L. L. C., a Johnson & Johnson company, is recruiting for
aManager 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.

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

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.
  • 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
  • Strong
    written and verbal communication skills
  • Understanding
    of master data management principles, tools and processes is
  • 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.

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