Regulatory Affairs

Job title: MD IDS – ASL (GRA)

Company: Lilly

Job description: Medicines Development Information and Digital Solutions (MD IDS) serves as a strategic function within Lilly Research Laboratories (LRL) partnering with the Medicines Development Unit (MDU). The MDU focuses on taking potential marketable products fro

Medicines Development Information and Digital Solutions (MD IDS) serves as a strategic function within Lilly Research Laboratories (LRL) partnering with the Medicines Development Unit (MDU). The MDU focuses on taking potential marketable products from Research through product registration and approval. MD IDSMD IDS focuses on the MDU business needs of the future, enabling improvements through information and technology solutions. The teams define and influence information and business strategies, design and develop solutions to achieve the strategic outcomes, and ensure reliable deployment and support of these solutions. The role of the MD IDS Application Support Lead acts as the primary, knowledgeable individual for a portfolio of IT applications and/or services in the Global Regulatory Affairs. This role works with a variety of resources to tactically maintain their applications within service levels, is well versed in the business processes, technologies including software-as-a-service, cloud data integration, data migration and assists in the management of vendor/user relationships tied to the applications and services. They engage with business partners, vendors, external service providers, and IDS partners to enhance and maintain the value and stability of the MD IDS application portfolio. Key Objectives and Deliverables: Business Analysis and Technical Integration Works with internal partners and external suppliers in ensuring that Global Regulatory Affairs deliver maximum business value, remain technically advanced, quality complaint, sustainable and cost effective. Develops in-depth business knowledge and strong relationships with business and IDS partners Focuses on business processes and technical aspects to evaluate and translate functional requirements into technical requirements Produces and maintains project documentation as required, including that of Computer Systems Quality Understands the application (new and legacy) data models and coordinates migration of data from legacy to new applications using various data migration tools and platforms.Modifies existing systems or integrates packaged systems with existing infrastructure to meet business requirements Ensures Lilly information assets are protected from malicious content and access to information is restricted to authorized personnel only Application Support Designs, implements and manages the Service Level Management process to deliver the end-to-end IT service at a level that supports the business need and requirements Leads and manages system enhancement projects including understanding and determining business impact, quantifying resource needs, and evaluating technical options Collects and analyzes relevant information to resolve incidents, problem tickets, and change requests (CRs) within committed service levels, and in accordance with local procedures Engages in continuous improvement through annual reviews of the Service Level Management process Assists support vendor and Lilly management with the management of support vendor resources and daily operational activities Incorporates ITIL methodology and best practices into support and service activities and deliverables Partners on various other support activities including audits, Periodic Reviews, and other CAPA tasks Required Technical Skills: Working knowledge of Veeva Vault, Oracle Database, PL/SQL and Java. Preferred Skills: AWS, Python, Modern Cloud architecture, OpenShift, GitHub, Linux, Veeva RIM (Regulatory Information Management) application, JavaScript and PowerBI. Basic Qualifications: Bachelor’s Degree Additional Skills/Preferences: 2+ years knowledge of the software development life cycle, spanning the entire lifecycle from project initiation to deployment, support, and retirement Experience with supporting enterprise wide Cloud applications such as Salesforce or Veeva Familiarity with ITIL Foundations framework Familiarity with Software Quality Assurance methods and techniques Experience with Global Regulatory Affairs business processes Excellent oral and written communication skills Excellent self-management skills Demonstrated initiative to build relationships, learn new business processes, technologies and identify opportunities Ability to achieve results through self and others Ability to influence peers Broad and deep technology learning agility Additional Information: Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Expected salary:

Location: Bangalore, Karnataka

Job date: Wed, 19 Jan 2022 23:56:47 GMT

Apply for the job now!