A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Associate QC Specialist
Job Description
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.
1. 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.
2. Develop and provide factual evidence to support all discrepant findings for review and approval by Submission Team or document authors.
3. Provide cross-divisional support through quality review of divisional specific documents such as CSRs, CERs, Tabular Listings, etc.
Candidate Profile
Bachelor’s degree required, advanced degree in scientific /health or management discipline preferred Fluent English language capabilities required
• ≥ 2 year experience in clinical research with proven proficiency in global clinical development.
• Ability to understand, interpret clinical/scientific 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.
Additional Information:
Experience: ≥ 2 years
Qualification : Bachelor’s degree
Location : Hyderabad
Industry Type: Pharma
Functional Area: Quality
Job ID: 243707BR
Last Date: 21st July, 2018
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