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Associate, Gra Business Technology, Rim System and

4 weeks ago


Bengaluru Karnataka, India Lilly Full time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

**Purpose**:
Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

**Business Process and Quality System management**
- Responsible for the maintenance of established business processes, including appropriate tools that support the processes.
- Ensure business processes are aligned with technology system workflows.
- Create and maintain process maps for assigned GRA business area.
- Finalize new or revised Quality documents, including procedures, tools, resource documents and job aids via regular communications with GRA Process Owners, Quality, and key stakeholders.
- Support execution of training courses to ensure Lilly colleagues are trained and appropriately qualified for business processes.
- Provide audit or inspection support through helping to gather audit materials during audit preparation and supporting audit requests in the audit/inspection ready rooms.
- Partner with relevant GRA Business Technology and Process team members to monitor performance metrics for applicable business processes and RIM system and support actions for improvement.
- Partner with Quality to support deviation management, change controls and self-assessments.

**Management for RIM Performance Support**
- Collaborate with GRA Business Technology team to ensure training courses and job aids for RIM users are maintained.
- Provide oversight management for resources on performance support site, including contact lists and FAQs.

**System Technology Implementation**
- Participate in business requirements discussions, design sessions and functional specification reviews with the technology teams and business partners.
- Lead and/or oversee execution of User Acceptance Testing for releases.

**Project Management**
- Support GRA Process Owners on initiation, planning and execution of Regulatory improvement projects.
- Provide project task management skills, and effective communication during assigned projects.
- Manage special projects or areas of focus, as needed, for the broader global regulatory affairs functions.

**Minimum Qualification Requirements**:

- Master’s degree (or equivalent work experience), preferably in a science or health-related field

**Other Information/Additional Preferences**:

- Regulatory affairs, Quality and/or process development experience
- Demonstrated exemplary teamwork and interpersonal skills
- Ability to manage multiple tasks with strong organization and project management skills
- Demonstrated attention to detail with accuracy
- Ability to adapt to a changing environment
- Self-motivated with ability to work independently
- Effective listening and communication skills, including writing and presenting

Lilly 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.

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