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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 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.

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:

• 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.

• 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 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 (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.

Asset Protection/Compliance

• Ensure compliance with all Federal, State and Local guidelines to include Regulatory Agencies regulations and Lilly policies and procedures.

Minimum Qualification Minimum Qualification Requirements:

• A minimum of 3-5 years in the biotechnology or pharmaceutical industry.

AND

• BS Degree in life science or computer science preferred

OR

• H.S. diploma with 5+ years of relevant work experience

Other Information/Additional Preferences:

The following skills and abilities are directly related to the essential functions of the job.

• Experience with CTD/eCTD structure and format.

• Experience using eCTD compliant publishing system (eCTDXpress or Veeva based platforms)

• 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

Computer Skills:

• 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

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.

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