Novo Nordisk BSc Jobs, Apply For Associate Clinical and Safety Publisher Role
Associate Clinical and Safety Publisher
Category: Clinical Development
Location: Bangalore, Karnataka, IN
Department: Clinical Reporting, GBS
Are you passionate about clinical publishing? Do you have a keen eye for detail and quality? Join us as an Associate Clinical and Safety Publisher at Novo Nordisk and make a significant impact in the world of clinical development. Read more and apply today for a life-changing career.
The Position
As an Associate Clinical and Safety Publisher, your role includes:
- Compiling and publishing clinical and safety documents, ensuring the quality of appendix material for Clinical Trial Reports (CTRs), and performing electronic quality control (eQC) of applicable documents.
- Ensuring the quality of non-clinical and safety reports.
- Collaborating effectively with stakeholders and colleagues.
Key Responsibilities:
- Compile and publish various documents such as CTRs, Non-interventional Study Reports (NSRs), and safety surveillance reports (PSURs, DSURs, Clinical Risk Management Plans, etc.) following 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 per SOPs.
- Coordinate and ensure the quality of appendices of clinical documents, planning and collecting appendix material, and adhering 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.
Qualifications
- Post-graduate degree in Pharmacy, Science, IT, Engineering, or a relevant bachelor’s degree.
- Minimum of 6 months of relevant experience in using Document Management Systems, MS Office, and 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 strong communication and stakeholder management skills.
About the Department
You will be part of the Clinical Reporting GBS team, responsible for managing all clinical development activities from the initial planning of clinical trials to authority submission. The team investigates patients’ reactions to new drugs, compares them to existing products, and conducts trials in human subjects. We offer resources in biostatistics, programming, clinical reporting, data management, epidemiology/real-world evidence, and clinical pharmacology for all development projects. Operating in a collaborative environment, we support development projects by aligning processes, optimizing competencies, and sharing knowledge.
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