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Job Details

Global Data Standards Owner, Regulated Product Domain

Company: Roche
Reference: 3410175216
Closing Date: 21 Sep 17
Type: Full Time
Salary (£): On Application

Job Summary:

Summary The Global Data Standards Owner Regulated Product Domain is accountable for the end-to-end management of data standards including requests, definition and adoption for the Regulated Product Data Domain. Drives and facilitates organization wide data standardization, re-use and good data citizenship. ...



  • The Global Data Standards Owner Regulated Product Domain is accountable for the end-to-end management of data standards including requests, definition and adoption for the Regulated Product Data Domain. Drives and facilitates organization wide data standardization, re-use and good data citizenship. 
  • Regulated Product Data Domain consists of: (1) shared data used across pharma, (2) Data that enables the IDMP submission processes and operations (3) Master Data that supports related regulatory and downstream users of such data; and (4) related reference data used as controlled lists etc. This domain has Dependencies on data from other domains to be determined.
Job Responsibilities
  • Manage the definition of data standards ensuring appropriate stakeholder involvement across business & IT, incorporating related industry and regulatory standards/requirements.
  • Steward existing standards ensuring they are current, approved and aligned with business sponsors meeting end-to-end business needs and promoting data reuse.
  • Educate and oversees appropriate training of those that use the standard such as data suppliers/consumers on the correct application of the standards
  • Final decision maker for standards and their application, with escalation to / oversight by governing bodies
  • Coordinate teams that execute the data standardization related activities
  • Facilitate and decide appropriate consumption for downstream usage of data in other domains, systems and reports, linking stakeholders with data providers
  • Oversee master data management execution if the DGO directly manages their data
  • Manage their metadata repository and glossary content for their domain in our defined standards repositories
  • Periodic review and update of existing standards to ensure relevance and meet current requirements
  • Oversee standards governance for their domain including standards adoption - partnering with systems, process, report, and data quality owners; and related functional leaders
  • Recognized as an expert in standards within their domain
  • Know and engage all stakeholders and represents their interests along with E2E thinking ensuring fit for purpose agreements
  • Manage the standards development core team and their activities
  • Manage their domain stakeholder/SME teams and the stakeholders communities ensuring cross-functional engagement in the standards process. (enabling inclusive perspectives, yet not consensus per se) 
  • Monitor ongoing data fidelity (e.g. quality, consistency, adoption) levels and other metrics which assess the adherence of data and people to data governance policies/Standards
  • Work within and beyond their immediate area to implement change in support of the adoption of data governance policies and standards
  • Facilitates compliance to external data regulations including GMP, CFR Part 11, HIPAA, etc. and internal quality, regulatory and audit requirements
Internal Customers:
Data Modelers, Business Analysts, Data Domain Leaders, Master Data Operations Manager

External Customers:
Business Leaders, Global Process Owners, Global Information Standards Governance Committee, Domain Stakeholder/Subject Matter Expert Team, System Owners, Information Architects, Data Content Owners, Data Operations Managers, Report Owners, Functional Leadership and Governance Teams, Project Leaders/Managers, Compliance/Regulatory Experts, Cross-Functional Data Governance Offices/Teams

Who you are

You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
Job Requirements and Competencies
  • Bachelor's degree in science, analytics or biology related field, (Master's degree preferred)
  • 6 or more years’ professional experience in the pharmaceutical/ biotechnology industry or related experience (preferably in clinical development)
  • Extensive Regulatory Product and related processes for submission and downstream usage experience in pharma R&D and Supply Chain Operations environment - 5 years min. 
  • Demonstrates a deep and comprehensive understanding of the importance and impact of data (or bad data) on the ability of the business to meet its own objectives.
  • Capability to navigate and influence complex organizational and cross functional relationships
  • Must display a strong cross functional, End-To-End understanding of standards within and across data domains to enable data sharing across the organization
  • Ability to clearly communicate business case problem statements and supporting cost benefit analysis
  • Ability to identify optimal approaches for resolving data quality or consistency issues to achieve targets
  • Knowledge of data modeling / architecture principles and techniques
  • Knowledge of process management and maturity methodologies
  • Experience with portfolio and project management
  • Experience with data or software development life cycle
  • Strong problem solving skills
  • Strong written and verbal communication skills

Who we are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

If you have a disability and need an accommodation in connection with the on-line application process, please email us at
EEO is the Law

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

Apply for this job: Global Data Standards Owner, Regulated Product Domain

Contact Information:

Address:  UK Head Office
P.O. Box 8, Welwyn Garden City, Hertfordshire, United Kingdom
Tel:  +44 1707 36 6000
Fax:  +44 1707 33 8297
Website:  Visit Our Web Site

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