Senior QC Specialist

☞ Novartis

View: 101

Update day: 06-05-2024

Location: Hyderabad / Secunderabad Telangana

Category: Information Technology Legal / Contracts Executive management Health / Medical Care Pharmacist / Pharmaceutical representatives Science Labor Serving / Cleaner / Maids PG / PB / Reception Event Education / Training

Industry: Healthcare

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Job content

300! That’s the approximate number of documents you will contribute to as a new QC Associate based at Novartis in Hyderabad. As part of Submission Management and Quality team you will be responsible for the clinical content review and identifying inaccuracies for preclinical and/or clinical documents (e.g. primarily Clinical Study Reports (CSRs) and High Level Documents (HLDs) contained within New Drug Applications (NDA), 120 day Safety Updates and Marketing Authorization Applications (MAA) filed by Novartis Pharmaceuticals to governmental Health Authorities around the globe.

Your responsibilities include, but are not limited to:

  • Assess validity of clinical/scientific interpretation described in preclinical, clinical and device documents provided to governmental Health Authorities and identify discrepancies. Provide independent clinical/scientific review of clinical summary documents (such as SCE, SCS, SCP, SBP and CO) and identify content inaccuracies prior to submission to Health
  • Authorities, verify accuracy (100% review) of all factual statements within summary document text compared to post-text sources cited. Verify numeric accuracy (100% review) of all data cited throughout text and hand derived in-text tables compared to post-text sources cited. 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. Train new and/or junior QC specialists to achieve department set goals for excellence in quality review. Develop and deliver new trainings on quality topics to junior QC Specialists
  • Provide cross-divisional support through quality review of divisional specific documents such as CSRs, CERs, Tabular Listings, etc. Compile comprehensive documents containing discrepancies identified from QC reviews (with corresponding factual ‘Evidence’) for each clinical summary document in preparation for resolution meeting.
  • Lead resolution of discrepant findings with Submission Team or author, including documenting actions, verifying implementation of findings and archiving results. Drive quality forward in the writing process through participation in draft review meetings, identifying potential discrepancies prior to content review.
  • Lead SMQ Quality work streams to streamline and further develop quality practices cross divisionally, from defining the problem to designing and implementing solutions. Contribute to RWS Initiatives to represent quality team and harmonize QC process with departmental goals.
  • Ensure continuous awareness of new governmental guidelines for NDA/MAA registration filings and ensure changes are appropriately applied to clinical summary documents (SCE/SCS/CO) effected.

Minimum requirements

  • Bachelor’s degree required, advanced degree in scientific/health or management discipline preferred
  • >=10 years’ experience in clinical research with proven proficiency in global clinical development.
  • Ability to understand, interpret complex clinical/scientific/statistical data and effectively
  • communicate inaccuracies in clinical summary documents to authors. Demonstrates strong medical/scientific communications (written)
  • Proven ability to work independently to deliver clinical summary document discrepant findings within defined timelines (e.g. 4-5 working days).
  • Previous experience in clinical development of NDA/MAA deliverables with knowledge in world-wide regulatory requirements for drug registration (e.g., Common Technical Document)
  • Solid computer technical skills (Word/Excel/PDF development) and ability to learn new systems quickly.

WHY NOVARTIS
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, 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!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
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

Business Unit

GDO GDD

Country

India

Work Location

Hyderabad, AP

Company/Legal Entity

Nov Hltcr Shared Services Ind

Functional Area

Quality

Job Type

Full Time

Employment Type

Regular

Shift Work

No
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Deadline: 20-06-2024

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