Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy.
Post : Clinical and Safety Publisher
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., 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.
About the Department
The Clinical Reporting unit in GBS has seen a tremendous growth curve and has become an integral part of the Global Clinical Reporting community in a short span of 6-7 years, since its inception in 2011. The team is a dynamic mix of enthusiastic and qualified skilled Medical Writers, Disclosure Medical Writers, Publishers and Document Controllers with Masters/PhD in life sciences, pharmacology, medicine, etc. The team is full of commitment, passion, skills, and talent with broad knowledge on different therapeutic areas and regulatory requirements for submissions. The team has an average experience of 7-8 years in writing and reviewing regulatory documents and publications. We use our scientific expertise to drive clear and impactful communication on the conduct and outcome of clinical trials. Apart from writing and publishing regulatory documents, the team is also responsible for distribution of documents (CONNECT portal) and largely contributes to NN’s regulatory commitments by being involved in public disclosure activities.
Candidate Profile
• 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.
Additional Information
Qualification : Post-graduate (Pharmacy, Science)
Location : Bangalore, India
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Clinical Development and Medical
End Date : 26th October, 2022
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