Data Standards and Operations Director

Created by: Johnson & Johnson
Added: 13.10.2020

Advert description

Job Description

The Director, RIM (Regulatory Information Management) Data Standards, Governance and Operations provides overall departmental leadership and is accountable for directing and driving the RIM Data Standards, Governance and Operations strategy, activities, and staff.

The position will be preferably based in Raritan, NJ; Titusville, NJ; Chesterbrook, PA, but we could also consider additional J&J locations in High Wycombe, UK; Leiden, Netherlands; or Beerse, Belgium.

Principal Responsibilities

  • Direct the GRA Data Standards and Governance activities, with focus on ensuring the continuous development, the governance, and the maintenance of the Data Standards, in close collaboration with all the GRA and RIM applications. Ensure central, regional, and local GRA business needs as well as overall efficiencies and quality are met. Ensure close alignment and appropriate interaction with other R&D, Pharma and Cross Sector initiatives on Data Standards and related governance.
  • Understand the impact of ICH IDMP (Identification of Medicinal Product) and direct the Regulatory contribution to the implementation strategy for the SPOR IDMP program in Europe.
  • Provide strategic input to the current and future tools and processes used to collect, share, submit and track Regulatory Submission Information and ensure the necessary related business support and services are provided to the GRA community in particular and the Pharma group in general.
  • Contribute expertise to internal or external initiatives to influence evolving policy and requirements that may impact the Regulatory Information Management capabilities.
  • Ensure the RIM applications are controlled and managed in a compliant manner.
  • Ensure development and governance of the Regulatory Applications Oversight from a business perspective to increase efficient use, consistency, and general knowledge across GRA staff and in relation to other R&D, Pharma and Cross Sector initiatives.
  • Lead a global team of experts via direct and indirect reports, and teams where required. Provide leadership that promotes employee development, promotes innovation, is customer focused, empowers and motivates others, fosters collaboration and diversity, and delivers results.

Qualifications

Qualifications

  • University/Bachelor’s or equivalent experience is required
  • Minimum of 10-12 years of data-oriented experience.
  • Strong data analysis skills with the ability to translate data into information, and strategies into actionable plans.
  • Advanced understanding of business aspects of data standards, data architecture and related governance.
  • Broad understanding of Business Process Design and Change Management Process.
  • Knowledge of quality management and/or compliance principles.
  • Knowledge of the drug development process.
  • Mastery within regulatory affairs and advanced understanding across and outside of regulatory affairs.
  • Excellent verbal and written communication skills, ability to work and thrive in a multi-cultural environment, and ability to work in a matrix environment.
  • Previous experience managing projects and working/leading project teams.
  • Strong networking and relationship building skills.
  • Conflict resolution/management and negotiation skills.
  • Facilitation, presentation, and meeting management skills for internal and external audiences at all levels.
  • Experience in people management is required


Location

The position can be based in Raritan, NJ; Titusville, NJ; Chesterbrook, PA; High Wycombe, UK; Leiden, Netherlands; or Beerse, Belgium.

This position may require up to 5% domestic and international travel.

Specific details

Type of Contract Full time
Preferred Education Bachelor's, Other
Level of Experience 10+ years

Location

Netherlands, Europe
Leiden