-Shristi Sharma, Team bioXone
Eli Lilly Job – Life Science Publishing Specialist Recruitment. Life Science eCTD publishing specialist Job Opening. Interested and eligible applicants can check out all of the details on the same below:
Name of the Post: eCTD publishing specialist
Req ID: R-6271
Location: Bengaluru, Karnataka, India
Purpose:
The Central Regulatory Registration (CRR) Submission Publisher creates as well as maintains US regulatory registrations from applicant selection with end of product lifecycle. The CRR Submission Publisher additionally creates global registrations as well as provides maintenance support as required for major markets (excluding Japan). The Submission Publisher meets customer needs by optimizing business procedures and also tools and also guaranteeing 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, various other publishing centers, vendors, and/or various other contributing areas to align on submission specific requirements and to guarantee adherence to submission regulations as well as standards. Although submission publishing work is technological, producing dossiers is a cross-functional process done in an environment of critical time frames and also potentially changing priorities, and, for that reason, a strong emphasis is placed on teamwork, communication, as well as self-management.
Responsibilities:
1. Plan submission workload:
- Responsible for managing multiple submissions types across assigned molecules.
- Coordinate as well as communicate with Regulatory Associates to plan compliance and also strategic submissions.
- Review as well as keep track of the CRR Calendar for planning documents for submissions.
- Maintain and also create the document as well as submission calendar entries: proactively update document status to manage workload and also provide information on specific documents’ status as it concerns any specific submission.
- Proactively manage 30-day packets to guarantee compliance.
- Maintain and also upgrade the submission table of contents.
- Escalate issues that might impact submissions and also 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 as well as combine files right into electronic submissions (eCTD) according to the master table of contents for the dossier.
- Retrieve and also publish CRFs and datasets required for regulatory submissions; help train as well as educate others concerning submission required CRFs as well as datasets; work closely with others to successfully meet CRF and also dataset time lines.
- Retrieve and publish literature references (bibliographies). Aid train and educate others concerning submission required literature references; work closely with others to successfully meet literature references time lines.
- Retrieve, publish, and Retrieve, procedure, publish, and also submit U.S. FDA required post-Marketing supplements and amendments (IsRA).
- Ensure compliance with 30-Day Packet and also Medication Watch submissions.
- Create different dossiers for Europe, the UNITED STATE, 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 guaranteeing all metadata fields are complete in eFiles.
- Manage FDA Webtrader account to make it possible for submissions using the electronic gateway.
- Assure all appropriate metadata fields are completed when archiving in an electronic filing system (eFiles).
- Assure accurate entry for future retrieval if/when requested.
4. Build on a high level of expertise in electronic publishing:
- Achieve a high level of technical as well as practical proficiency with eCTDXPress and Adobe Acrobat.
- Successfully complete the formal training modules.
- Stay up to date on the system and also tool upgrades that impact publishing.
- Share technical info amongst staff members as well as apply what is learned to the day to-day work.
- Apply learning from quality review of submission work.
- Keep up to date in subject matter expert area.
5. Help with various other submission-related tasks, as appropriate:
- Train various 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 also procedures.
- Guarantee quality assurance of submission documents as well as materials.
- Adhere to all required formal as well as informal training.
- Comply promptly and also thoroughly with all investigation or audit requests.
- submit UNITED STATE FDA required periodic reports; aid educates and train others about periodic reports, consisting of information about the respective internal processes and also work closely with others to successfully meet periodic report timelines.
Basic requirements:
Minimum Qualification Requirements. The following abilities and also capabilities are directly connected to the essential functions of the job:
- Postgrad in Life Sciences.
- Minimum 2 to 6 years of pertinent experience in eCTD publishing domain.
- Strong high-end PC abilities as well as word processing/editorial abilities.
- Sound organizational skills and also the capability to prioritize work.
- Accuracy, detail-oriented.
- Flexibility, the capability to handle time pressures.
- Must have the ability to work as a team member and independently.
- Self-motivated.
- Effective communication/interpersonal abilities.
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