Associate / Senior Associate - Clinical Publisher - Regulatory Delivery Excellence (Submission Publisher)At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Eli Lilly Cork is made up of a talented diverse team of over 1,800 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our 'Live Your BEST Life' wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself.
12 month contract position. Purpose: The purpose of the Regulatory Delivery Excellence (RDE) Submission Publisher role is to:
Create and maintain regulatory registrations from candidate selection through end of product lifecycle.Create global registrations and provide maintenance support as needed for major markets.Meet customer requirements by optimizing business processes, tools and ensuring implementation of the regulatory agency's preferred electronic common technical document (eCTD) specifications in a quality way to promote timely review by the regulatory agency.Build eCTD expertise and partner 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 domain in an environment of critical time frames and potentially changing priorities, and, therefore, a strong emphasis is placed on teamwork, communication, and self-management.
Primary Responsibilities: Execute submission workload:Responsible for managing multiple submission types across assigned molecules.Coordinate and communicate with Regulatory Associates to execute planned compliance and strategic submissions.Proactively manage 30-day packets to ensure compliance.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.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.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.Build technical and quality expertise:Understand changes to Regulatory Guidance and Requirements and advise RDE Management as to their potential impact on Publishing.Asset Protection/Compliance:Ensure compliance with all Federal, State and Local guidelines to include Regulatory Agencies regulations and Lilly policies and procedures.Minimum Qualification Requirements: A minimum of 3-5 years in the biotechnology or pharmaceutical industry.Experience with CTD/eCTD structure and format.Experience using eCTD compliant publishing system.BS Degree in life science or computer science preferred or equivalent work experience.Other Information: This position reports functionally to a RDE publishing Manager.This position is office-based work at Global Business Solutions Center (GBS) based at LCCI, India and Cork, Ireland.The shift for the position is Monday through Friday, 8 hours a day. Some overtime may be required.The statements contained in this document are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be an exhaustive list of all responsibilities, duties and skills of personnel so classified.
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