Novo Nordisk Clinical Publisher Vacancy 2020 - Pharma

Novo Nordisk Clinical Publisher Vacancy 2020 – Pharma

Novo Nordisk Pharma Job – Pharma Apply Online. Postgraduate and undergraduate pharma candidates apply. candidates are eligible to apply online for a Medical Information Therapeutic Manager post. Medical Information Therapeutic Manager position that is available at Novo Nordisk

Job Title: Clinical Publisher in Global Development

Qualifications

You are expected to have the below skills and knowledge:

  • Post-graduate (Pharmacy, Science, Engineering) or relevant bachelor’s degree
    Minimum 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
  • Ability to communicate, plan and coordinate multiple simultaneous activities
  • Excellent communication and stakeholder management skills
  • Ability to communicate with people from different professional and cultural backgrounds

The position

As a Clinical Publisher, you are responsible to perform 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 etc. Plan the collection of appendix material in collaboration with the study group as applicable for the relevant clinical documents to ensure appropriate appendix

material is in compliance with GCP, Novo Nordisk SOPs and international guidelines and support document owners through sharing knowledge about content requirements, as well as the use of novoDOCS and other requirements such as scanning standards to publish clinical documents (as required) according to current Novo Nordisk standards for regulatory publishing.

  • Ensure quality control of the published output is performed according to current Novo Nordisk standards for regulatory publishing to ensure distribution of final documents according to valid SOPs also make sure legacy documents are indexed into novoDOCS for regulatory submissions as applicable for the relevant clinical documents. Also you need to ensure electronic quality control (eQC) of clinical documents is performed according to current Novo Nordisk standards for regulatory publishing at relevant timelines and support the organisation in use of novoDOCS and clinical templates.
  • The Clinical Publisher needs to cooperate and communicate with colleagues from many departments within headquarters and in the affiliates and Clinical Development Centres to ensure timely collection of required documentation and must be service-minded, a good team player and able to work effectively across language and cultural differences.

Working at Novo Nordisk

At Novo Nordisk, we have been changing diabetes since 1923. If you are ready to strengthen our position as an innovative pioneer and respected industry leader, we encourage you to join us to make the most of your talent. In exchange, we offer you the opportunity to work with extraordinary talent globally and benefit from a range of possibilities for professional and personal development.

Contact

For further information, please contact Shivalingappa – [email protected]

Deadline For The Application 05 Sep 2020

Apply Online

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