Eli Lilly Hiring Intern-GRA Post graduate degree in health sciences discipline Pharmacy, chemistry or related scientific discipline Apply Now
Purpose
The CMC regulatory intern will support 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.
Minimum Qualification Requirements:
Post graduate 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.
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