Intern - eCTD Publishing

6 months ago

Bengaluru, India Lilly Full time

We’re looking for people who are determined to make life better for people around the world.

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:

o retrieve and publish CRFs and datasets required for regulatory submissions

o retrieve and publish literature references (bibliographies)

o retrieve, publish, and submit U.S. FDA required periodic reports

o retrieve, process, publish, and submit U.S. FDA required post-Marketing supplements and amendments

o ensure compliance with 30-Day Packet and Med Watch submissions.

o 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 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.

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.

#WeAreLilly

  • Intern - Ectd Publishing

    2 weeks ago

    Bengaluru, Karnataka, India Lilly Full time

    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...

  • Ectd Publishing

    6 months ago

    Bengaluru, Karnataka, India Lilly Full time

    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...

  • Lead Associate, Publisher

    1 month ago

    Bengaluru, India Genpact Full time

    Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients. Powered by our purpose – the relentless pursuit of a world that works better for people –...

  • Technical Associate: Publisher

    4 months ago

    Bengaluru, India Genpact Full time

    Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients. Powered by our purpose – the relentless pursuit of a world that works better for people –...

  • Regulatory Publisher

    6 months ago

    Bengaluru, India Indegene Full time

    Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most...

  • Regulatory Affairs Specialist: Publisher

    2 weeks ago

    Bengaluru, Karnataka, India Genpact Full time

    Genpact is a global professional services firm that delivers outcomes that shape the future. Our team of experts serves and transforms leading enterprises, including Fortune Global 500 companies.We are seeking an experienced Publisher with demonstrated ability to execute responsibility in a highly regulated & process-driven environment.The Role demands...

  • Document Publishing Specialist

    2 weeks ago

    Bengaluru, Karnataka, India Lilly Full time

    We are seeking a highly skilled Document Publishing Specialist to join our team at Lilly.The ideal candidate will have a strong understanding of electronic publishing and be able to manage submissions, prepare submission cover letters and forms, and plan submission workloads.Key Responsibilities:Manage Submissions: Prepare submission cover letters and forms...

  • Publisher Sales

    6 months ago

    Bengaluru, India Global consultings Full time

    **Role: Senior Manager-Publisher Sales** **Key Responsibilities** - Prospect, acquire and grow relationships with strategic publishers. - Manage team of 2-3 Publisher Development Representatives - Contribute to Datawrkz's publisher development strategies. - Study client's existing advertising options and consult them on the most appropriate approaches to...

  • Publisher account manager

    2 weeks ago

    Bengaluru, India TGM Full time

    Publisher Account ManagerLocation: Hybrid (Remote + Office)Experience Required: 2-5 years in Digital Publishing or Programmatic AdvertisingRole SummaryAt The Germane Media LLC , we’re committed to empowering publishers and optimizing their monetization strategies. As a Publisher Account Manager , you will be pivotal in ensuring publisher satisfaction,...

  • Publisher Account Manager

    2 weeks ago

    Bengaluru, India TGM Full time

    Publisher Account ManagerLocation: Hybrid (Remote + Office)Experience Required: 2-5 years in Digital Publishing or Programmatic AdvertisingRole SummaryAt The Germane Media LLC , we’re committed to empowering publishers and optimizing their monetization strategies. As a Publisher Account Manager , you will be pivotal in ensuring publisher satisfaction,...

  • Publisher Account Manager

    2 weeks ago

    Bengaluru, India TGM Full time

    Publisher Account ManagerLocation:Hybrid (Remote + Office)Experience Required:2-5 years in Digital Publishing or Programmatic AdvertisingRole SummaryAtThe Germane Media LLC , we’re committed to empowering publishers and optimizing their monetization strategies. As aPublisher Account Manager , you will be pivotal in ensuring publisher satisfaction,...

  • Marketing Executive

    6 months ago

    Bengaluru, India Cleverfox Publishing Full time

    **Designation: Marketing Executive** **Location: Bangalore (Opp to JP Nagar Metro)** Experience: Minimum 1 year (required) **About Clever Fox Publishing** Clever Fox Publishing is India’s fastest-growing end-to-end hybrid book publisher, with an enviable network spread across 150+ countries, 1200+ physical bookstores and a highly-engaged community of...

  • Publisher Account Manager

    2 weeks ago

    Bengaluru, India TGM Full time

    Publisher Account ManagerLocation: Hybrid (Remote + Office)Experience Required: 2-5 years in Digital Publishing or Programmatic AdvertisingRole SummaryAt The Germane Media LLC, we’re committed to empowering publishers and optimizing their monetization strategies. As a Publisher Account Manager, you will be pivotal in ensuring publisher satisfaction,...

  • Publisher Account Manager

    2 weeks ago

    Bengaluru, India TGM Full time

    Publisher Account ManagerLocation: Hybrid (Remote + Office)Experience Required: 2-5 years in Digital Publishing or Programmatic AdvertisingRole SummaryAt The Germane Media LLC, we’re committed to empowering publishers and optimizing their monetization strategies. As a Publisher Account Manager, you will be pivotal in ensuring publisher satisfaction,...

  • Publisher Account Manager

    2 weeks ago

    Bengaluru, India TGM Full time

    Publisher Account Manager Location: Hybrid (Remote + Office) Experience Required: 2-5 years in Digital Publishing or Programmatic Advertising Role Summary At The Germane Media LLC , we’re committed to empowering publishers and optimizing their monetization strategies. As a Publisher Account Manager , you will be pivotal in ensuring publisher...

  • Publisher development executive

    2 weeks ago

    Bengaluru, India TGM Full time

    Publisher Development ExecutiveLocation: Hybrid (Remote + Office)Company OverviewAt The Germane Media LLC (TGM) , we are one of the fastest-growing providers of advertising solutions, dedicated to building a cleaner, safer, and more effective programmatic advertising ecosystem. Our mission is to revolutionize programmatic advertising for publishers,...

  • Publisher Development Executive

    3 weeks ago

    Bengaluru, India TGM Full time

    Publisher Development ExecutiveLocation: Hybrid (Remote + Office)Company OverviewAt The Germane Media LLC (TGM) , we are one of the fastest-growing providers of advertising solutions, dedicated to building a cleaner, safer, and more effective programmatic advertising ecosystem. Our mission is to revolutionize programmatic advertising for publishers,...

  • Regulatory Publisher 2

    6 months ago

    Bengaluru, Karnataka, India Veranex, Inc. Full time

    Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables...

  • Publisher Development Executive

    2 weeks ago

    Bengaluru, India TGM Full time

    Publisher Development ExecutiveLocation:Hybrid (Remote + Office)Company OverviewAtThe Germane Media LLC (TGM) , we are one of the fastest-growing providers of advertising solutions, dedicated to building a cleaner, safer, and more effective programmatic advertising ecosystem. Our mission is to revolutionize programmatic advertising for publishers,...

  • Regulatory Associate

    6 months ago

    Bengaluru, India Indegene Full time

    Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most...