Regulatory Data Strategy Leader

07 Dec 2018
03 Feb 2019
Regulatory Data Strategy Leader

The Digital Revolution is increasing the amount of data available for internal and external use that will bring incredible value to Pharma. This will require that data is made easily accessible to meet strategic business objectives, including data used for regulatory decision making.  The capability required for management and control of data will continue to grow as more and more devices, technologies and services harvest more and more information.  To meet this evolving business need, the Data Strategy Team within PD Regulatory is being established.  The Data Strategy Leader will be responsible for set up and execution of the Data Strategy Team establishing effective management and governance of data, as well as planning for the possibilities with data into the future.   

This person needs to be an innovative thinker with an enterprise mindset which will be required to establish the future vision and strategy for regulatory data.   This person needs to be a strong motivator, leader and facilitator of virtual teams of all levels, from executive to tactical.

This position will report to the Global Head of Strategic Operations.

Key Responsibilities
  • Establish and embed the future vision and strategy for regulatory data.  
  • Develop phased implementation plan to mature the state of regulatory data.
  • Drive the overall strategy, analysis, planning and execution of key data governance, policy and master data initiatives PD Regulatory.
  • In partnership with IT, develop and implement service level agreement - how data is designed, structured, what is being asked.
  • Establish capabilities across metadata, data quality, authoritative sourcing and master data management.
  • Implement tools and advanced technologies to support capabilities, leveraging automation where possible.
  • Create and implement data provisioning strategy; identify and appoint authoritative data sources, establish data sharing requirements and provisions, develop provisioning point registration, classification and selection process, develop and own data accountability matrices.
  • Develop authoritative source adoption roadmap (sourcing simplification/remediation plan).
  • Establish and maintain data governance.
  • Establish and manage Data Strategy team including hiring, management and development of direct report(s).
  • Drive adoption of data management capabilities to ensure data is managed effectively as a valuable asset to inform decision-making, monitor risk and increase efficiency and effectiveness.
  • Oversees the integrity and usability of critical data assets.
  • Provide thought leadership within regulatory and across the enterprise on use of regulatory data, including new data sources such as digital healthcare and real-world evidence.
  • Support internal efforts to leverage data at scale to advance Personalized Health Care, including review of policy positions and participation in stakeholder meetings (e.g. Health Authorities).  
  • Identify and drive process improvement opportunities based upon metrics, quality issues, audit/inspection findings, compliance, deviation trends, and feedback from other capabilities.
  • Identify training, change management and communication activities needed for the capability and drive implementation of any changes within their capability.
  • Responsible for administering and enforcing the Data Governance process with Data operation managers (DOMs) and data content owners (DCOs).
  • Develop, maintain and update Data Governance Policy and related standards.
  • Establish cross-functional collaboration with other enterprise control function executives to ensure data is properly managed across the entire data eco-system.

Required Skills
  • 8-10 years experience in strategic business operations and/or data/information architecture development and implementation.
  • Experience with enterprise architecture domains of data, applications and solution design.
  • Life science and regulatory domain knowledge of current trends (PHC, RIM, etc.).
  • Business case development.  
  • Change and portfolio management; able to carve out strategic initiatives from the "art of the possible".
  • Project and program delivery.
  • Understanding of the data lifecycle management.  
  • Experience applying technologies such as ML, RPA, NLG, NLP.
  • Proven experience with data governance including data analytics, data modeling and data operations.
  • Proven experience in implementing a data strategy and acquisition.
  • Database, non-relational systems, data modeling and data warehouse proficiency.
  • Extensive leadership experience.
  • People and resource management experience.
  • Strong content knowledge of data governance and industry practices.
  • Politically astute and ability to communicate effectively.
  • Ability to effectively monitor industry and regulatory activities and assess impact on data governance practice.
  • Excellent listening, written, and oral communication skills.
  • Strong organizational, analytical, and decision-making skills.
  • Ability to anticipate and solve problems.
  • Energetic, innovative, and flexible.

Closing date for applications is Friday 4th January 2019.

Roche is an equal opportunity employer.
Business Development, Business Development > Strategic Business Development