Intern - eCTD Publishing

2 days ago

Bengaluru, India Lilly Full time

We’re looking for people who are determined to make life better for people around the world.

Manage submissions

• Prepare Submission Cover letters and forms per appropriate regional submission and route for appropriate review and

approval.

• Plan submission workload by reviewing/monitoring the RDE RIM or Share Point Calendar for planned documents for

registration submissions.

• Partner with the Regulatory Associate to retrieve, publish, and submit Modules 1-5 reports/documents and combine

files into electronic submissions (eCTD) according to the master table of contents or Content Plan for the dossier.

Examples include:

o retrieve and publish CRFs and datasets required for regulatory submissions

o retrieve and publish literature references (bibliographies)

o retrieve, publish, and submit U.S. FDA required periodic reports

o retrieve, process, publish, and submit U.S. FDA required post-Marketing supplements and amendments

o ensure compliance with 30-Day Packet and Med Watch submissions.

o create different dossiers for Europe, the U.S., Canada, or other supported worldwide markets. Dossiers are

distributed to regulatory agencies and Lilly affiliate offices worldwide.

• Share knowledge, help train and educate others: about general submission knowledge including CRFs, datasets,

submission required literature references(bibliographies), periodic reports, post-Marketing supplements and

amendments.

• Coordinate global registration activities and provide the necessary documentation to affiliates for registration of

products in global countries. Duties include preparing and/or expertise in requesting Indiana Free Sale Certificates,

FDA Certificates of Pharmaceutical Product (CPPs), MOH GMP Certificates, Price Certificates, Regulatory Status

Letters, and Letters of Clarification.

Submit and archive registrations

• Submit and archive submitted registrations, incoming correspondence, and Records of Contact with Regulators

assuring all metadata fields are complete in eFiles or RIM.

• Manage FDA Web trader account to enable submissions via electronic gateway.

• Assure all appropriate metadata fields are completed when archiving in electronic filing

system (eFiles or RIM).

• Assure accurate entry for future retrieval if/when requested.

Build on high level of expertise in electronic publishing

• Achieve a high level of technical and practical proficiency with eCTD XPress, Adobe

Acrobat, Submission Validation software (Lorenz), ISIToolbox.

• Successfully complete the formal training modules.

• Stay up to date on system and tool upgrades that impact publishing.

• Share technical information among staff members and apply what is learned in day-to-day work.

• Apply learning from quality review of submission work.

• Keep up to date in subject matter expert area.

Build technical and quality expertise

• Understand changes to Regulatory Guidance and Requirements and advise RDE

• Management as to their potential impact on Publishing.

• Keep current on latest quality improvement methods.

• Ensure best practices through partnership with Regulatory Quality.

Build Subject Matter Expertise within the Publishing Role and Process:

Oversight of QC process

• Maintain QC process, checklists, and training materials.

• Provide training for QC pool activities (those performing QC).

• Ensure QC pool is aligned on process, interpretation of checklist items and QC feedback to publishers.

• Provide technical leadership to QC personnel in resolving any QC issues or questions.

• Assess needs and participate in skill enhancement exercises or opportunities.

Oversight of Publishing Calendars

• Monitor the Submission Publishing calendar to ensure daily submission work is

appropriately assigned and prioritized.

• Serve as point of contact and subject matter expert for publishing calendars.

• Ensure clear calendar training is up to date for users and conduct training as needed.

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.

#WeAreLilly

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