Regulatory Data Governance is working to harmonize data dictionaries for our new Regulatory Informaion Management (RIM) tool. This includes harmonizing controlled lists across product types, regions and business entitites. Dictionary content must be compliant with regulations globally.
This role is to follow and support Data Governance processes to ensure compliance, quality and oversight of data and metadata. Additionally this role will monitor updates to CVs from regulatory agencies and industry standards organizations, ensuring Regulatory CVs and terms are current and compliant, extraction of controlled vocabularies (CVs) and terms from the Regulatory Agencies (FDA/NCI, EMAs OMS/RMS), ROW as applicable), and Industry Standards Organizations. Data Governance processes include coordination with Data Owners and Data Governance teams, conduction of impact analysis (of changes from Agencies, Organizations and individual requestors), planning, preparation and implementation of changes to CVs in the Regulatory RIM too (Veeva Vault). This will also require some coordination with system leads of specific internal to-be legacy systems (SHARE, DOMASYS, CRYSTAL, RWS, RAeDocs, etc) until they are archived, to ensure alignment and mapping between dictionaries is maintained. ]
location: Bridgewater, New Jersey
job type: Contract
salary: $41 - 44 per hour
work hours: 8am to 5pm
Responsibilities also include supporting query generation for the purpose of data quality oversight. Candidates should be self-directed and proactive in identifying and evaluating data quality issues and to communicate these to the Data Governance Team. Candidate should also be a team player, able to work collaboratively with the many roles supporting Data Governance and the RIM System.
- Accountable that rules established for the data model are applied accurately and consistently
- Run metrics & KPIs to ensure data quality (consistency, completeness, accuracy, timeliness)
- In collaboration with the Business Data Owner, define data structure and data business rules
- Maintain associated pick lists (controlled vocabularies) within systems
- This role works under the oversight and supports the Head of Data Definitions, Standards and Governance (DDSD) in the Regulatory Operations Organization
Bachelor of Science degree, preferably in technical area.
skills: Experience with Regulatory data, metadata and with maintaining Regulatory dat dictionaries a must. Experience with EMAs (OMS/RMS), FDA data standards preferred. Good communication skills required. Experience with Veeva Vault tool a plus.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.