Offer summary

Qualifications:

High School diploma or equivalent, Associate degree preferred, Strong PC skills and organizational abilities, Familiarity with medical terminology beneficial.

Key responsabilities:

Plan submission workload and manage submissions

Submit and archive registrations

Build expertise in electronic publishing

Assist with related tasks and ensure compliance

Job description

Job title: Regulatory Affairs Specialist (0-3)
Job Id: 1394
Location: Remote/ Indianapolis, IN
Duration: 19 Months
Job Description:
Minimum Qualification Requirements:
The following skills and abilities are directly related to the essential functions of the job.

High School diploma or equivalent, Associate degree preferred.
Strong high-end PC skills and word processing/editorial skills
Sound organizational skills and ability to prioritize work
Accuracy, detail-oriented
Flexibility, ability to handle time pressures
Must be able to work as a team member and independently
Self-motivated
Effective communication/interpersonal skills
Working knowledge of medical terminology is helpful

Purpose:
The Central Regulatory Registration (CRR) Submission Publisher creates and maintains US
regulatory registrations from candidate selection through end of product lifecycle. The CRR
Submission Publisher also creates global registrations and provides maintenance support as
needed for major markets (excluding Japan). The Submission Publisher meets customer
demands by optimizing business processes and tools and ensuring implementation of the
regulatory agency's preferred electronic common technical document (eCTD) specifications in a
quality way to aid a timely review by the regulatory agency. The Submission Publisher builds
eCTD expertise and partners with Regulatory Associates, Regulatory Scientists, other
publishing centers, vendors, and/or other contributing areas to align on submission specific
requirements and to ensure adherence to submission regulations and guidelines. Although
submission publishing work is technical, producing dossiers is a cross-functional process done
in an environment of critical time frames and potentially changing priorities, and, therefore, a
strong emphasis is placed on teamwork, communication, and self-management.

Responsibilities:

1. Plan submission workload

Responsible for managing multiple submissions types across assigned molecules.
Coordinate and communicate with Regulatory Associates to plan compliance and
strategic submissions.
Review and monitor the CRR Calendar for planned documents for submissions.
Maintain and create document and submission calendar entries: proactively update
document status to manage workload and provide information on specific documents'
status as it pertains to any specific submission.
Proactively manage 30-day packets to ensure compliance.
Maintain and update the submission table of contents.
Escalate issues that may impact submissions and timelines.

2. Manage submissions for assigned molecules

Partner with contributing areas (e.g., GMC, Data Services, Regulatory Scientists, NIS,
RACMC, etc.) to retrieve, publish, and submit Modules 1,2, and/or 5 reports/documents
and combine files into electronic submissions (eCTD) according to the master table of
contents for the dossier.
Retrieve and publish CRFs and datasets required for regulatory submissions; help train
and educate others about submission required CRFs and datasets; work closely with
others to successfully meet CRF and dataset time lines.
Retrieve and publish literature references (bibliographies). Help train and educate others
about submission required literature references; work closely with others to successfully
meet literature references time lines.
Retrieve, publish, and submit U.S. FDA required periodic reports; help educate and train
others about periodic reports, including information about the respective internal
processes and work closely with others to successfully meet periodic report time lines.
Retrieve, process, publish, and submit U.S. FDA required post-Marketing supplements
and amendments (IsRA).
Ensure compliance with 30-Day Packet and Med Watch submissions.
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.

3. Submit and archive registrations

Submit and archive submitted registrations, incoming correspondence, and ROCs
assuring all metadata fields are complete in eFiles.
Manage FDA Webtrader account to enable submissions via electronic gateway.
Assure all appropriate metadata fields are completed when archiving in electronic filing
system (eFiles).
Assure accurate entry for future retrieval if/when requested.

4. Build on high level of expertise in electronic publishing

Achieve a high level of technical and practical proficiency with eCTDXPress and Adobe
Acrobat..
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 to the dayto-day work.
Apply learning from quality review of submission work.
Keep up to date in subject matter expert area.

5. Assist with other submission-related tasks, as appropriate

Train other Submission Publishers.
Develop procedures and/or job aids.
Define and refine processes by looking for efficiency gains.
Perform validation testing of new software.
Represent the Submission Publishers at cross-functional meetings, etc.

6. Asset Protection/Compliance

Ensure compliance with FDA/Regulatory Agencies regulations and Lilly policies and
procedures.
Ensure quality assurance of submission documents and materials.
Comply with all required formal and informal training.
Comply promptly and thoroughly with all investigation or audit requests.

Required profile