Pharma Clinical and Safety Publisher Vacancy - Novo Nordisk

Pharma Clinical and Safety Publisher Vacancy – Novo Nordisk

Novo Nordisk clinical and safety vacancy, Pharmacy job opening 2022, M Pharma job opening 2022, Pharmacy job opening 2022, Novo Nordisk job opening 2022, Pharma job opening 2022, Pharmacy job opening. Intrested and eligible candidates may check out all the details on the same below:

Job Title: Clinical and Safety Publisher

Category: Clinical Development and Medical

Location: Bangalore, Karnataka, IN

Department– Clinical Reporting, GD-GBS

Eligibility Criteria:

  • Post-graduate (Pharmacy, Science) 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.

The Position:

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., reg

arding 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.

Apply Online

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