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Senior Associate QC Specialist
Job ID: 378860BR
Job Description
Job 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 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.
Minimum requirements
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.
Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud ofthis, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Division: Global Drug Development
Work Location: Hyderabad, AP
Company/Legal Entity: Nov Hltcr Shared Services Ind
Functional Area: Quality
Employment Type: Regular
Early Talent: No
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