Novartis QC Opening For Life Science Candidates – Apply Online
Novartis QC Opening For Life Science Candidates – Apply Online. Novartis opening in QC department for specialist. The latest Life Science QC Job details are provided below. Please go through the same and apply now.
Job role – Senior Associate QC Specialist
Work Location – Hyderabad
Job ID – 378860BR
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.
Hello friends, you can go through the below given expected interview question and answers. Prepare well for your Life Science QC Job. All the best!!!
Question: Can you describe your experience in assessing and verifying the validity of clinical and scientific content in preclinical and clinical documents? How have you identified deficiencies and inaccuracies in your previous roles? Answer: In my previous roles, I’ve been extensively involved in assessing the validity of clinical and scientific content in various types of documents, including preclinical and clinical study reports. One approach I’ve used is comparing the content within these documents against the original data sources. For instance, when verifying numeric accuracy, I meticulously cross-reference data presented in-text and in tables with the actual data sources cited. This helps me identify any discrepancies or inconsistencies that might have occurred during the document preparation process.
Question: The role involves conducting independent source data verification for clinical or preclinical study reports. Could you provide an example of a challenging situation where you had to verify numeric accuracy and appropriateness of citations? How did you approach this task? Answer: Certainly. In a recent project, I was tasked with verifying the numeric accuracy of complex data presented in a clinical study report. To ensure accuracy, I began by meticulously cross-referencing each data point with its source, such as laboratory reports or patient records. This involved not only verifying the numerical values but also confirming the units of measurement and statistical calculations. Simultaneously, I reviewed the internal and external citations within the report to ensure they correctly corresponded to the referenced sources. This approach helped identify a few inconsistencies, which I documented and communicated to the authors for clarification and correction.
Question: Communication is crucial in this role. Can you share an instance where you effectively communicated inaccuracies in clinical summary documents to authors or the Submission Team? How did you ensure that your findings were well-understood and acted upon? Answer: Certainly. In a previous role, I discovered inconsistencies in the presentation of data and a few inaccuracies in a clinical summary document. To communicate this effectively, I drafted a detailed report highlighting each discrepancy and providing evidence from the original sources. I ensured that my communication was clear and concise, avoiding technical jargon that could lead to misunderstandings. I also reached out to the authors and held a brief meeting to walk them through the findings and the supporting evidence. This collaborative approach fostered a positive environment, enabling the authors to promptly address the issues and make necessary corrections.
Question: Working within defined timelines is important. Could you discuss a project where you had to work independently to deliver accurate results within a tight timeframe, such as 4 working days? How did you manage your time and prioritize tasks to meet the deadline? Answer: In a recent project, I had a tight deadline of 4 working days to review and verify a comprehensive clinical study report. To manage my time effectively, I first outlined the document’s key sections and associated tasks. I allocated time slots to each section, keeping in mind the complexity and potential challenges. This allowed me to maintain a steady pace throughout the review process. I focused on tackling the most data-intensive sections first to ensure accurate data verification. By adhering to this schedule and maintaining clear communication with my team, I successfully met the deadline without compromising the quality and accuracy of the review.
Question: Experience with CSRs and NDA/MAA deliverables is preferred. Can you elaborate on your involvement in the clinical development of such documents in your previous positions? What specific contributions did you make to ensure the quality and accuracy of these documents? Answer: In my previous role, I was actively involved in the clinical development of Clinical Study Reports (CSRs) and contributed to the preparation of New Drug Applications (NDA) and Marketing Authorization Applications (MAA) deliverables. I collaborated with cross-functional teams to ensure that the content was aligned with the latest data and met regulatory requirements. I focused on verifying the accuracy of data, performing thorough source data verification, and meticulously reviewing citations and references to ensure consistency and compliance. My contributions included providing detailed feedback to authors, collaborating on revisions, and presenting factual evidence to support any discrepancies identified during review. This proactive approach helped enhance the quality and accuracy of the documents before submission to Health Authorities.
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