Novo Nordisk Hiring Clinical and Safety Publisher for Bangalore

• Job Description:
• Qualifications

Clinical and Safety Publisher Job Openings in Novo Nordisk at Bangalore location. Interested & Eligible Candidates Apply now

Category:  Clinical Development and Medical
Location:  Bangalore, Karnataka, IN

Department ; Clinical Reporting, GD-GBS

Are you passionate about quality and simplification? Do you want to build quality within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment and support your colleagues and stakeholders by challenging the status quo in a friendly and open-minded way? If so, there is a job opportunity waiting for you as our new Clinical Publisher. At Novo Nordisk, we will challenge you to do the best work of your life. Apply Now.

Job Description:

• Clinical Publisher will be responsible for Compilation and publishing of clinical documents including but not limited to Clinical Trial Reports (CTRs), Investigator’s Brochures (IB), Non-intervention Study Reports (NSRs), Clinical summaries and overviews, lay summaries etc.
• Plan and coordinate the collection of appendix material in collaboration with the medical writer, study group and local affiliates.
• Check appendix documentation and ensure adherence to internal and regulatory publishing standards (e.g., regarding navigation, bookmarks, hyperlinks, margins, header).
• Support clinical users and troubleshoot issues related to the clinical templates. Perform eCTD checks of reports including but not limited to Non-clinical CRO Reports, Non-clinical Section Reports for Clinical Trial Reports, Non-clinical Principal Investigators Reports, Clinical CRO Reports for Clinical Trial Reports etc according to internal PDF check list. Contribute and conduct knowledge sharing sessions and sharing better practices in the team.

Qualifications

• 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, 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

Contact : To submit your application, please upload your CV online (click on Apply and follow the instructions).

Deadline : Apply before 26th October 2022.

Novo Nordisk commit to an inclusive recruitment process and equality of opportunity for all our job applicants.