Novartis QC Opening For Life Science Candidates – Apply Online
Job role – Senior Associate QC Specialist
Work Location – Hyderabad
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 –
Your responsibilities include, but are not limited to:
- Assess validity of clinical/scientific content in preclinical and clinical documents and identify deficiencies prior to finalization and promotion in the document management system.
- Provide independent source data verification of clinical or preclinical study reports and identify content inaccuracies, e.g.:
a. Verify accuracy (100% review) of all factual statements within summary document text compared to post-text sources cited.
b. Verify numeric accuracy (100% review) of all data cited throughout text and hand derived in-text tables compared to post-text sources cited.
c. Verify appropriateness of all internal/external citations noted within summary document.
- Develop and provide factual evidence to support all discrepant findings for review and approval by Submission Team or document authors.
- Provide cross-divisional support through quality review of divisional specific documents such as CSRs, CERs, Tabular Listings, etc.
- With oversight, provide clinical/scientific review of clinical summary documents, such as CERs, SCE, SCS and CO.
WHAT YOU’LL BRING TO THE ROLE:
- Minimum university higher degree in life sciences/healthcare or equivalent ≥ 3 years’ experience in clinical research with proven proficiency in global clinical development.
- Ability to understand, 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 to deliver results within defined timelines (e.g. 4 working days).
- Previous experience in clinical development of CSRs and NDA/MAA deliverables preferred.
- Solid computer technical skills (Word/Excel/PDF development) and ability to learn new systems quickly.