The Regulatory Affairs division of a major pharmaceutical company is embarking on a critical program to improve systems and processes for entering, authoring and reporting information to government and regulatory bodies throughout the drug development lifecycle. The current systems are managed separately, data entry is highly manual, and information is not easily accessible due to lack of system integration. The user base needs a common set of information that can be aggregated and consumed by the appropriate parties when they need it.
The need is for a Senior Data Architect to develop the data & integration architecture and information delivery strategy within a multi-tier platform for distribution of Regulatory information to various users (i.e. to Regulatory, Pharmaceutical, R&D, and Health Authorities). The role is focused heavily on data integration and information management and requires deep skills in all aspects of data design, data modeling and integration between internal and external systems utilizing data management technologies (including RDBMS, MDM, SOA/ESB, and Data Virtualization). Experience with data management, data harmonization, data quality management, and data governance is preferred.
The Enterprise Data Architect will start on a 4 month engagement, with a very high likelihood of extension and strong possibility of working on additional enterprise-wide, strategic data architecture programs.
The Senior Data Architect will:
- Develop Data Management and Integration strategies and solutions to manage and govern information based on business needs and future-state vision
- Develop Information & Master Data Model applying Regulatory and industry standards, and identifying mappings to Authoritative and Trusted Data Sources
- Recommend Data Integration and Technology Strategy leveraging MDM and Integration Hub platforms
- Determine information distribution and synchronization models to trigger data workflow across systems and maintain integrity of the data across systems and enterprise-wide
- Assist with data standardization and harmonization efforts and provide leadership instituting data governance and data quality management best practices
- 15 years of Strong experience in Data Architecture with large, F500 companies including data integration and SOA design experience. Expert in developing data integration and data management (MDM) strategies.
- Able to articulate and communicate a data architecture and integration vision, understand the technologies in the marketplace and provide a strategic perspective to staff and executive management while also able to roll-up sleeves, build a data model, and ensure successful execution of the strategy
- Must have very strong experience creating data architecture and integration solutions using proprietary in-house developed and off-the-shelf vendor-developed tools and integrating with internal/external systems
- Must have experience developing information models and data designs (e.g. chen, barker notations, etc., tools such as ER/Studio, ERWIN, etc.), including producing both conceptual/logical/physical models
- Strong understanding of different EAI disciplines, tools and methodologies using SOA and MDM (e.g. ESB, EAI, RDBMS, WSDL, REST, ETL).
- Heavy database and integration tool experience with Oracle RDBMS, Tibco ESB & BPM experience, Informatica/Siperian MDM, and Informatica ETL and Data Virtualization tools (IDS)
- Knowledge of BI and reporting tools. Tool knowledge includes relational databases and content management systems, preferably Documentum.