Eli Lilly

GRA Regulatory Delivery Excellence, Global Submission Publisher

Eli Lilly • $63K — $149K *
Indianapolis, IN 46227In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • 5+ years of experience in the Pharmaceutical Regulatory industry
  • Strong understanding of CTD/eCTD structure and format
  • Experience with eCTD compliant publishing systems like eCTDXpress
  • Regulatory operations experience with major applications and amendments
  • Proficiency in MS-Office Suite and Adobe Acrobat, including submission readiness tools

Responsibilities

  • Manage and coordinate multiple submission types across assigned molecules
  • Prepare necessary submission documents and manage submission workflow
  • Monitor document status and update plans for timely submissions
  • Build eCTD expertise among team members and provide training
  • Ensure compliance with Federal, State, and Local regulatory guidelines

Benefits

  • Comprehensive medical, dental, vision, and prescription drug benefits
  • 401(k) and pension plan eligibility
  • Flexible benefits options, including healthcare spending accounts
  • Vacation and paid time off benefits
  • Well-being programs like employee assistance and fitness benefits
Full Job Description
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:

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 Requirements:
  • H.S. diploma AND
  • 5+years of Pharmaceutical Regulatory industry experience
  • Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.


Additional Preferences:
  • BS Degree in life science or computer science preferred
  • Knowledge of drug development process
  • Previous experience working in the Pharmaceutical industry

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

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$63,000 - $149,600

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly

About Eli Lilly

ICOS Corporation is a biotechnology company that engages in the discovery, development, and commercialization of therapeutic products. It is engaged in the commercialization of treatments for unmet medical conditions, such as benign prostatic hyperplasia, hypertension, pulmonary arterial hypertension, cancer, and inflammatory diseases. It is the developer of a treatment known as Cialis (tadalafil), a product for the treatment of erectile dysfunction through its joint venture with Eli Lilly and Company in North America and Europe. It is also engaged in contract manufacturing services for third parties. It is in a strategic alliance with Solvay Pharmaceuticals, Inc. ICOS Corporation was established in 1989, based in Bothell, Washington. It is currently operated by Eli Lilly and Company.

Eli Lilly Careers

Joining Eli Lilly offers an unparalleled opportunity to become part of a leading global team dedicated to creating a healthier future. As a company revered for its commitment to innovation and leadership in the pharmaceutical industry, Eli Lilly is where your professional journey can flourish. Work You’ll Do At Eli Lilly, we are passionate about transforming patient care and advancing medical innovation. Our team at Eli Lilly is at the forefront of developing groundbreaking solutions in healthcare. By joining us, you will collaborate with some of the brightest minds in the industry, using cutting-edge technology to make real-world impacts. Lead with Innovation and Leadership Eli Lilly stands out in the marketplace by integrating deep industry expertise with robust research and development efforts. We are looking for professionals who are eager to drive change and lead the way in developing therapeutic breakthroughs. Explore Job Opportunities and Growth Eli Lilly offers a variety of career paths, including full-time positions and internships, across multiple functions such as research, marketing, IT, and sales. Whether you are a seasoned professional or a recent graduate, Eli Lilly provides an environment that promotes career growth and learning opportunities. Our commitment to diversity and leadership training ensures that every employee can achieve their potential. Be Part of Our Team Our team at Eli Lilly is committed to excellence and driven by a mission to improve lives. Employees enjoy a supportive culture that values collaboration, creativity, and diversity. We believe that a diverse workforce fosters innovation and helps us better connect with the communities we serve. Benefits and Culture Eli Lilly is dedicated to supporting our employees, offering competitive benefits, wellness programs, and comprehensive health care. Our culture is built on a foundation of respect, integrity, and quality, making Eli Lilly not just a great place to work, but a community to grow with. Networking and Professional Development Eli Lilly encourages continuous professional development and networking. With access to various training programs and mentorship opportunities, employees can enhance their skills and advance their careers. Our leadership is committed to nurturing talent through effective training and development strategies. Join Our Team Discover the exciting job opportunities at Eli Lilly by exploring open positions that match your skills and interests. We are continuously hiring and looking for individuals who are passionate, innovative, and ready to contribute to our mission of making life better for people around the globe. Stay Connected Keep up to date with the latest at Eli Lilly by following our careers blog. Gain insights from industry leaders and get tips on everything from crafting the perfect resume to preparing for your interview. Eli Lilly is not just a company—it's a place where you can make a difference. Explore the positions available and find out how your talents can help change the world. SEARCH ELI LILLY JOBS Stay ahead in your career with Eli Lilly, where innovation, leadership, and a commitment to diversity and growth lead the way to future advancements.
Learn more about Eli Lilly
Size
35,000 employees
Market Cap
$344.2 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.1 billion
Founded
1876
5 Year Trend
+5.9%
Revenue
$24.5 billion
NASDAQ
LLY
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Eli Lilly

More Pharmaceuticals & Biotech Jobs

Find similar GRA Regulatory Delivery Excellence, Global Submission Publisher jobs:

NationwideIndianapolis, IN