Senior Associate QC Specialist


ob Purpose

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 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.

Diversity & Inclusion / EEO

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements


• 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.

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