Novo Nordisk Clinical Publishing Job For Pharma Candidates - Apply Online Now
"Unveiling the Perfect Job in Clinical Publishing at a Global Healthcare Leader!"

Novo Nordisk Clinical Publishing Job For Pharma Candidates – Apply Online Now

Associate Clinical and Safety Publisher

Category: Education

Location: Bangalore, Karnataka, IN

Department – Clinical Reporting GBS

Are you detail-oriented and experienced in compiling and publishing clinical and safety documents? Are you passionate about ensuring the quality and compliance of regulatory submissions? We are looking for an Associate Clinical Safety Publisher to join our team at Novo Nordisk. If you are ready for a new challenge and want to make a difference in the healthcare industry, read on and apply today for a life-changing career.

About the department

The Clinical Reporting unit in GBS has experienced significant growth since its inception in 2011, becoming a key part of the Global Clinical Reporting community within 6-7 years. Our team consists of enthusiastic and highly qualified Medical Writers, Disclosure Medical Writers, Publishers, and Document Controllers, many with advanced degrees in life sciences, pharmacology, and medicine. With an average of 7-8 years of experience in writing and reviewing regulatory documents, our team is known for its commitment, passion, and expertise across various therapeutic areas and regulatory requirements. We leverage our scientific knowledge to create clear and impactful communications about clinical trials. In

addition to writing and publishing regulatory documents, we manage the distribution of documents through the CONNECT portal and play a vital role in Novo Nordisk’s regulatory commitments through public disclosure activities.

The Position:

As Associate clinical and safety publisher, your role involves compiling and publishing clinical and safety documents, ensuring the quality of appendix material for Clinical Trial Reports (CTRs), performing electronic quality control (eQC) of applicable documents, and ensuring the quality of non-clinical and safety reports. Additionally, the role requires collaborating effectively with stakeholders and colleagues. Responsibilities include compiling and publishing various documents such as CTRs, Non-interventional Study Reports (NSRs), and safety surveillance reports (PSURs, DSURs, Clinical Risk Management Plans, etc.) in accordance with Novo Nordisk standards and regulatory guidelines.

As Associate Clinical Safety Publisher at Novo Nordisk, you will have the responsibilities to:

  • Perform compilation and publishing of clinical and safety documents including Clinical Trial Reports (CTRs) and Non-interventional Study Reports (NSRs), safety surveillance reports (PSURs, DSURs, Clinical Risk Management Plans, etc.) in accordance with Novo Nordisk standards and regulatory guidelines.
  • Create assemblies in ePub format as applicable and process published documents to ensure compliance with internal and external requirements for regulatory submissions.
  • Manage finalization documents, including uploading to EDMS (Vault), initiating workflows, collecting signatures, and distributing final documents according to SOPs.
  • Coordinate and ensure the quality of appendices of clinical documents, including planning and coordinating the collection of appendix material and ensuring adherence to SOPs and regulatory publishing standards.
  • Perform electronic quality control (eQC) of clinical and safety documents to ensure submission readiness according to Novo Nordisk standards and timelines.


  • Post-graduate (Pharmacy, Science, IT, Engineering) or relevant bachelor’s degree.
  • 2+ years of relevant experience in the routine use of Document Management Systems, MS Office, and Portable Document Format (PDF) tools including Adobe Acrobat Professional and ISI toolbox.
  • General knowledge and understanding of FDA, ICH, and other regulatory electronic documentation requirements.
  • Good team player with communication and stakeholder management skills.

Working At Novo Nordisk

Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we’re working toward something bigger than ourselves, and it’s a collective effort. Join us! Together, we go further. Together, we’re life-changing.


If you believe you are a match for the above requirements and are willing to take up the role, please apply here with our online application tool.


31st May, 2024.


Keywords: Associate Clinical and Safety Publisher, Novo Nordisk, Clinical Reporting, Clinical Trial Reports, Safety Reports, Regulatory Compliance, Healthcare Industry. Novo Nordisk Clinical Publishing Job For Pharma Candidates – Apply Online Now. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.


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