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 : Senior Associate QC Specialist
Job Description
• 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.
Candidate Profile
• 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.
Additional Information
Experience : ≥ 3 years
Qualification : Higher degree in life sciences/healthcare
Location : Hyderabad, AP
Industry Type : Pharma
Functional Area : Quality
End Date : 30th July, 2023
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