Novartis Associate QC Specialist Job For Life Sciences, Apply Online

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

Business Unit: GCO 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

Early Talent: No

APPLY ONLINE

Possible Interview Questions for the Technical Round:

1. Can you explain the importance of source data verification in preclinical and clinical documents? How would you approach identifying content inaccuracies in such documents?
   • Answer: Source data verification is crucial in ensuring the validity and accuracy of information presented in preclinical and clinical documents. As an Associate QC Specialist, I would carefully review the documents, comparing the information with the cited sources and post-text sources. By conducting thorough assessments, I would identify any deficiencies or inaccuracies and provide factual evidence to support my findings. This process helps maintain the integrity and reliability of the documents filed with Health Authorities.
2. How would you handle complex clinical and scientific data during the review process of clinical summary documents? How would you effectively communicate any inaccuracies to the document authors?
   • Answer: When reviewing clinical summary documents, it’s essential to have a strong understanding of complex clinical and scientific data. I would carefully analyze the data, ensuring that it is accurately represented and interpreted in the document. If any inaccuracies or deficiencies are found, I would approach the document authors with factual evidence and clear communication. By providing specific examples and explanations, I would effectively convey the inaccuracies and collaborate with the authors to address and rectify them.
3. Describe your experience with cross-divisional support and quality review of division-specific documents. How would you ensure consistency and adherence to quality standards?
   • Answer: In my previous role, I provided cross-divisional support by conducting quality reviews of various division-specific documents, such as CSRs, CERs, and Tabular Listings. To ensure consistency and adherence to quality standards, I would follow established guidelines and templates, paying attention to detail and accuracy. By providing constructive feedback and suggestions, I would work collaboratively with the respective teams to improve the quality of the documents and ensure alignment with regulatory requirements.
4. Can you discuss a time when you worked independently to deliver results within defined timelines? How did you prioritize your tasks and maintain productivity?
   • Answer: In a previous project, I was responsible for reviewing clinical summary documents and providing feedback within a strict timeline of four working days. To prioritize my tasks and maintain productivity, I established a structured workflow and timeline, allowing sufficient time for each document review. I utilized effective time management techniques, such as setting deadlines for specific sections and allocating dedicated time for comprehensive reviews. By maintaining focus, organization, and efficient work habits, I successfully delivered results within the defined timelines.
5. How have you utilized your computer technical skills and ability to learn new systems quickly in a regulatory environment? Can you provide an example of a situation where you applied these skills to enhance document development or efficiency?
   • Answer: In my previous role, I leveraged my computer technical skills to develop and optimize documents using software such as Word, Excel, and PDF tools. I quickly grasped new systems and software platforms, allowing me to enhance document development processes and improve efficiency. For instance, I implemented automated templates in Word to streamline the creation of standardized sections, saving time and ensuring consistency. Additionally, I utilized Excel’s data analysis capabilities to extract meaningful insights from large datasets, contributing to the accuracy and efficiency of document preparation.