Novo Nordisk is a global leader in healthcare with a century-long legacy of pioneering innovation to combat chronic diseases. Renowned for its strong foundation in diabetes treatment, the company has expanded its mission to touch millions of lives worldwide, impacting over 40 million patients daily. With a team of over 63,000 dedicated employees across the globe, Novo Nordisk fosters an inclusive and collaborative environment that values unique skills and perspectives, fueling the company’s growth and its commitment to change lives.
Job Overview Novo Nordisk is seeking an Associate Clinical and Safety Publisher to join their Clinical Reporting GBS team in Bangalore, India. This role is ideal for individuals passionate about clinical publishing and committed to ensuring the highest quality in clinical and safety documentation. The role involves compiling and publishing essential documents, conducting quality checks, and managing submissions according to global regulatory standards.
Key Responsibilities
- Compile and publish clinical and safety documents such as Clinical Trial Reports (CTRs), Non-interventional Study Reports (NSRs), and safety surveillance reports (e.g., PSURs, DSURs, Clinical Risk Management Plans) in line with Novo Nordisk standards and regulatory guidelines.
- Create ePub format assemblies and process published documents to meet internal and external regulatory requirements.
- Manage finalization documents, upload them to the Electronic Document Management System (EDMS), initiate workflows, collect signatures, and distribute documents as per SOPs.
- Coordinate and ensure the quality of appendix materials for clinical documents, adhering to regulatory publishing standards and SOPs.
- Perform electronic quality control (eQC) checks to ensure that clinical and safety documents are submission-ready and meet Novo Nordisk’s quality standards.
Qualifications Candidates should meet the following requirements:
- A post-graduate degree in Pharmacy, Science, IT, or Engineering, or a relevant bachelor’s degree.
- At least 6 months of experience using Document Management Systems, Microsoft Office, and PDF tools such as Adobe Acrobat Professional and ISI toolbox.
- General understanding of FDA, ICH, and other regulatory electronic documentation requirements.
- Strong communication and stakeholder management skills.
- Ability to work effectively as part of a team.
About the Department The Clinical Reporting GBS team at Novo Nordisk plays a vital role in overseeing clinical development activities, from the planning of clinical trials to the submission of results to authorities. The team conducts thorough investigations into patient responses, performs comparative analyses with existing treatments, and ensures the comprehensive execution of clinical trials. The department offers expertise in biostatistics, clinical reporting, data management, and other essential areas, fostering a dynamic and collaborative environment for clinical development projects.
