Lilly Associate / Senior Associate - Clinical Publisher in Cork, Ireland
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 35,000 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.
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 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 domain 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: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
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.
Review and monitor the RIM or Share Point Calendar for delivery of planned documents in support of submissions and proactively update document status to manage workload and provide information on specific documents’ status as it pertains to any specific submission ensuring submissions are proactively processed such that they are delivered according to the planned submission date.
Escalate issues that may impact submissions and timelines.
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:
retrieve and publish CRFs and datasets required for regulatory submissions
retrieve and publish literature references (bibliographies)
retrieve, publish, and submit U.S. FDA required periodic reports
retrieve, process, publish, and submit U.S. FDA required post-Marketing supplements and amendments
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.
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.
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.
Technical leadership - for electronic publishing systems and process
Build and maintain high level of expertise in eCTD regulations and electronic publishing systems: eCTD XPress and accompanying tools.
Understand changes to Regulatory Guidance and Requirements and advise RDE Management as to their potential impact on tools, processes, procedures, publishing strategies and best practices with eCTD.
Provide technical leadership and timely answers to Submission Publishers on eCTD questions/issues to achieve a high level of technical and practical proficiency.
Provide feedback/training to business contributors and drive establishment of best practices and internal standards.
Create and maintain an open forum to discuss day to day publishing issues and drives implementation of any needed improvements or solutions.
Provide timely answers to requests from management, RAs, QC, and external parties regarding eCTD issues.
Partner with respective eCTD IT experts to ensure customer needs are understood for timely and validate solutions for routine system processes and tool updates.
Assist in end user testing where appropriate.
Training Assistant -Oversight of Submission Publishing Training program
Oversees the creation and management of submission publishing training materials.
Consults with the regulatory registrations process owner and subject matter experts on the content and delivery of training materials.
Responsible for ensuring that training processes for orientation of new resources are defined and maintained as submission processes evolve.
Provide guidance and coaching to those resources identified to assist in the delivery of training.
- 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/Additional Preferences:
The following skills and abilities are directly related to the essential functions of the job.
Three years of regulatory operations experience within a regulated environment with experience and knowledge in formatting and publishing medium/high complexity major applications, amendments, and supplements (manufacturing, nonclinical, clinical).
Experience with Original IND and supplemental NDA/BLA eCTD submissions including complex lifecycle submissions.
Strong knowledge of global health authority and ICH regulations and guidance as it pertains to format and submission structure.
Current knowledge of CBER/CDER regulatory technical requirements
Proficiency with MS-Office Suite and Adobe Acrobat, including pdf plug-ins that support submission readiness
Experience with document management and Regulatory Information Management Systems (RIM)
Broad technical knowledge (MS Word, Adobe Acrobat PDF Bookmarks and Hyperlinks, Acrobat Plug-ins, Document Management Systems, Excel, ISI Toolbox, Lorenz)
The individual must be able to maintain the security of confidential 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.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
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.