Associate QC Specialist For Life Sciences at Novartis India
About Novartis:
Novartis is a global healthcare company that provides solutions to address the evolving needs of patients worldwide. They focus on discovering, developing, and manufacturing innovative medicines, as well as generic pharmaceuticals and eye care devices. Novartis is committed to improving healthcare and enhancing the quality of life for individuals around the world.
About the role
As an Associate QC Specialist for Life Sciences at Novartis, you will be responsible for providing source data verification and identifying content inaccuracies for preclinical and/or clinical documents, such as study reports, contained within New Drug Applications (NDA) and Marketing Authorization Applications (MAA) filed by Novartis Pharmaceuticals to governmental Health Authorities.
Your key responsibilities:
- Assess the validity of clinical/scientific content in preclinical and clinical documents and identify deficiencies before finalizing and promoting them in the document management system.
- Provide independent source data verification of clinical or preclinical study reports and identify content inaccuracies.
- Develop and provide factual evidence to support any discrepant findings for review and approval by the Submission Team or document authors.
- Provide cross-divisional support through quality review of division-specific documents such as CSRs, CERs, and Tabular Listings.
- With oversight, provide clinical/scientific review of clinical summary documents.
Role requirements:
- Minimum university higher degree in life sciences/healthcare or equivalent with 2 years of experience in Medical writing/Narrative writing OR Quality Control of Clinical Documents.
- Ability to understand and interpret complex clinical/scientific and statistical data and effectively communicate inaccuracies in clinical summary documents to authors.
- Demonstrates strong medical/scientific communications (oral and written).
- Proven ability to work independently and deliver results within defined timelines.
- Previous experience in the clinical development of CSRs and NDA/MAA deliverables preferred.
- Solid computer technical skills (Word/Excel/PDF development) and ability to learn new systems quickly.
To apply for this position, please click here. (Ensure that you have read the requirements and responsibilities before applying.)
Keywords: Associate QC Specialist, Life Sciences, Novartis, India, preclinical documents, clinical documents, study reports, source data verification, NDA, MAA, health authorities, accuracy, content inaccuracies, cross-divisional support, quality review, CSRs, CERs, clinical summary documents, medical writing, narrative writing, quality control of clinical documents. Associate QC Specialist For Life Sciences at Novartis India. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook
