Technical Delivery Lead – Regulatory Affairs - SSP

Remote Contract Position

If interested, email your resume to shawn.mills@nttdata.com, or contact directly at 201-835-2715.

Technical Delivery Lead Regulatory Affairs
This role is to establish an understanding of current end to end IT Regulatory Affairs Data Management and Operations IT environment, establish the future technical design for environments, software platforms, data and analytical needs to enable to meet or surpass business and IT needs. In addition, the ability to quickly achieve a clear understanding of how things are designed, developed, and implemented across the regulatory affairs systems landscape. This understanding will allow this role to work closely with subject matter experts and development teams to establish a clear vision and consistency across the overall architecture.

Key responsibilities include:

• Responsible for the solution design and delivery of Regulatory Affairs Data Hub, Data Governance, Data Catalog, Data Access Request and IDMP Submission systems.
• Contribute to innovation, and thinking/working out of the box as appropriate and when possible, to achieve efficiency for a better user experience
• Keep abreast of innovative technologies, work processes, industry practices, and standards
• Interact with business users, solution/software providers, and IT colleagues to brainstorm and implement solutions
• Proactive participation in defining system design, system, and user acceptance testing, and ensure completion of required GxP and Systems Development Lifecycle (SDLC) documentation
• Contribute to liaison and track performance of production support activities and escalate concerns in an appropriate forum for corrective action
• Ensure activities are conducted in compliance with company policies and standards, in addition to regional and country specific regulations
• Plans technical design by studying the future site concept and corporate strategy
• Ability to envision architectural scheme, information structure and features, functionality, and user-interface designs; leverages current best practices in cloud-based design and development.

Primary Tasks include:

• Daily Scrum participation.
• Requirement feasibility analysis and validation.
• Architecture designing and getting approval from IT, Architect group and Product team.
• Review and approve implemented application architecture and code.
• Perform Capacity Planning and infrastructure estimates.
• Align multiple teams: Development, Testing, Release Management and Business for overall delivery
• Support development/test/PM teams in determining the timelines and estimates on the requirements.
• Initiate and execute the Risk Assessments (IT and Data Privacy) for major releases.
• Perform Vulnerability Scans for each release, ensure high risk findings are closed before production release.
• Identify, manage, mitigate, and resolve project risks effectively and efficiently
• Communication with stakeholders and Management and apprise status periodically.
• SDLC documents technical review and approval.
• Review and Approve Test Scripts for System Testing and Performance Testing.

Qualifications

Skills:

• Minimum of 10 years of IT solution delivery experience
• Minimum of 5 years of engineering and solution delivery with Life Sciences GxP systems
• Demonstrated ability to analyze and define business problems and identify appropriate technology solution(s)
• Client Domain knowledge is an advantage
• Drive for results augmented by strong planning and organization skills
• Deliver customer value - committed to understanding and meeting customer needs
• Collaborates effectively with and through others to achieve shared goals
• Strong Communication skills for verbal, written, and technical presentations
• Demonstrates ethics and integrity
• Ability to lead and manage multiple teams across multiple projects

Technologies Required:

• Strong understanding of AWS components & architecture, ETL (StreamSets), Airflow and APIs, File share technologies for consumer apps.
• Familiarity of Bitbucket for storing the Application Code.
• Familiarity with Agile methodology and DevOps concepts/tools.
• Experience with cloud-based architecture which includes AWS, AWS Glue, Collibra, Microsoft Azure, Appian, data storage, Stream Sets, Athena, Airflow, and analytical reporting as part of a corporate environment
• Familiar w/ AzureDevOPs & GitFlow source control pattern
• Familiar with cloud development and how to optimize code to minimize operational costs
• Comfortable creating & administering CI/CD pipelines with Azure Cloud and Jenkins

Bonus Skills:

• Background with preparing data models, data lakes, data warehouses; designing information structure, and dataflow; constantly evaluating information representation and conducting meetings to drive long term data efficiencies
• Has extensive experience with on-premise and cloud designs and architecture
• Experience with Documentum, PAREXEL/Calyx/Insight, Veeva Vault RIM, Cognos Reporting tools, workflow tools (Appian, TIBCO, Active Matrix, Uipath), and API frameworks (Apigee)
• Experience with Data Analytics
• Experience with BI visualization products (Qlik Sense, PowerBI, Spotfire)
• Experience working with on premise, Cloud capabilities, and software as a service (SaaS)

The Company is an equal opportunity employer and makes employment decisions on the basis of merit and business needs. The Company will consider all qualified applicants for employment without r egard to race, color, religious creed, citizenship, national origin, ancestry, age, sex, sexual orientation, genetic information, physical or mental disability, veteran or marital status, or any other class protected by law. To comply with applicable laws ensuring equal employment opportunities to qualified individuals with a disability, the Company will make reasonable accommodations for the known physical or mental limitations of an otherwise qualified individual with a disability who is an applicant or an employee unless undue hardship to the Company would result.