Novo Nordisk is currently seeking an Associate Clinical and Safety Publisher for their Bangalore, India location. This role involves compiling and publishing 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), for more information and application link please check below details
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 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..
Qualifications:
- Post-graduate (Pharmacy, Science, IT, Engineering) or relevant bachelor’s degree.
- Minimum 6 months 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.
About the department
You will be part of the Clinical Reporting GBS team, responsible for running all clinical development activities from initial planning of clinical trials towards authority submission. Our team investigates patients’ reactions to new drugs, compares them to existing products, and conducts a set of pre-specified trials in human beings. We provide biostatistics and programming, clinical reporting, data management, epidemiology/real-world evidence, and clinical pharmacology resources to all development projects. Located in a dynamic and collaborative environment, we support all development projects by aligning processes, optimising competencies, and sharing knowledge.
Contact
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.
Deadline
Apply on or before: 22nd November 2024.