Lilly Chemistry GRA-Intern Recruitment 2020 – Apply Online
Lilly Intern-GRA Post Pharma & Chemistry job opening at Lilly. Chemistry job opening at Lilly. Pharma job opening at Lilly. Lilly Intern-GRA Recruitment – Applications Invited. Intern-GRA Job Opening.
Job Title: Intern-GRA
Minimum Qualification Requirements:
- Postgraduate degree in health sciences discipline (e.g. pharmacy, chemistry
or related scientific discipline).
Other Information/Additional Preferences:
- Knowledge of drug development process.
- Demonstrated written, spoken and presentation communication.
- Demonstrated attention to detail.
- Basic understanding of CTD structure for regulatory submissions.
- Demonstrated ability to effectively prioritize and manage competing priorities and responsibilities.
- Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles.
- Knowledge of MS Word and Adobe PDF.
- Demonstrated effective teamwork skills; adapt to diverse interpersonal styles.
- Ability to multi-task and work under tight timelines.
- Proficient with Microsoft Word, PowerPoint, Excel, and Desktop Publishing Software.
Purpose
The CMC regulatory intern will support the implementation of the Regulatory Information Management (RIM) system. They will support data migration from existing regulatory databases to RIM. This role involves coordination with the RIM team and stakeholders at manufacturing locations and country affiliates.
Responsibilities:
- Responsible to create tracking sheets for country affiliates to complete to reflect current CMC regulatory commitments. Responsible for resolving discrepancies with regulatory commitments for those individual markets, handling documentation confirming compliance, and monitoring assessment completion due dates.
- Responsible to complete complex spreadsheets with metadata from current submission documents to ensure accurate document migration.
- Responsible to support submissions related to advertising and promotional material.
Support the management of the RIM training database by maintaining realistic scenarios at the appropriate step of the process in order for trainees to execute training exercises effectively. - Support CMC submission management process by providing knowledge of CMC regulatory requirements, including a comprehensive knowledge of ICH CTD.
- Support the submission management process to ensure all required electronic records are timely, complete, and accurate. Track affiliate submission and market approvals.
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