QC Specialist

Job Description

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: Responsible for metrics in respective area. Provide training in respective area. Supports, initiates, and leads continuous improvement activities for the quality assurance systems on site e.g. document management, change control and training Ensures that quality assurance systems e.g. document management, change control system, training, escalation management and risk management are in compliance with local and global requirements If leadership role, Efficient department management in accordance with annual plan (budget / activities / timelines) and defined objectives Assess validity of clinical/scientific interpretation described in preclinical and clinical documents provided to governmental Health Authorities and identify discrepancies. Provide independent clinical/scientific review of clinical summary documents (such as SCE, SCS and CO) and identify content inaccuracies prior to submission to Health Authorities, e.g.: a. 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. 3. Develop and provide factual evidence to support all discrepant findings for review and approval by Submission Team or document authors. Provide QC review of device specific documents with guidance from senior specialists. Compile comprehensive documents containing discrepancies identified among QC reviewers (with corresponding factual Evidence ) for each clinical summary document in preparation for resolution meeting. Support the resolution of discrepant findings with Submission Team or author, including verification of implementation, documenting and archiving results. Drive quality forward in the writing process through participation in draft review meetings, providing early identification of potential discrepancies. Minimum requirements Bachelor s degree required, advanced degree in scientific /health or management discipline preferred Fluent English language capability required >7 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 (written) Proven ability to work independently to deliver clinical results within defined timelines (e.g. 4 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 NOVARTIS769 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 whats 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,

Keyskills :
risk managementquality assurance systemstechnical skillsstudy reportsitem response theorycontrol systemchange controlon sitestatements of work sow