Associate Clinical and Safety Publisher

2 weeks ago

Bengaluru Karnataka, India Novo Nordisk Full time

Associate Clinical and Safety Publisher

**Category**:Clinical Development**Location**:Bangalore, Karnataka, IN

**Department**: Clinical Reporting, GBS-
**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.**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 recognise 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.**Contact**Deadline**_Disclaimer _**
- It has been brought to our attention that there have recently been instances of fraudulent job offers, purporting to be from Novo Nordisk and/or its affiliate companies. The individuals or organizations sending these false employment offers may pose as a Novo Nordisk recruiter or representative and request personal information, purchasing of equipment or funds to further the recruitment process or offer paid trainings. Be advised that Novo Nordisk does not extend unsolicited employment offers. Furthermore, Novo Nordisk does not charge prospective employees with fees or make requests for funding as a part of the recruitment process._
- We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.- At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the wor

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