Job Description! 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), 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:
•Lead SMQ Quality Team; Provide submission QC expertise to all direct reports and submission teams supported by Global Submission Management
•Accountable for QC training and demonstrated competence on SOPs, templates and related processes
•Resource planning, management and tracking ensure QC coverage for all supported projects; Innovate process excellence and productivity for QC practices
•Track and report overall submission program quality metrics & Performance management; Train and ensure competence of direct reports ability to enable delivery of high-quality QC findings to submission teams
•Manage, coach, and develop associates to establish a high performing team; Recruit and retain talent
•Manage Submission QC services; Identify internal Novartis process issues that affect QC or vendor operations or performance, and actively address with the responsible internal stakeholders
•Participate and represent RWS/GDO in global process improvement initiatives serve as faculty member for Development training programs, or as author or reviewer for clinical SOPs
Minimum requirements•Bachelor’s degree required, advanced degree in scientific /health or management discipline preferred; Fluent English language capabilities required; > = 10 years clinical research experience with proven ability to lead cross-functional teams
•Thorough understanding of clinical submission deliverables required for MAA/NDA filings as well as EMA and FDA regulatory guidelines for submissions.
•Has direct supervisory experience (≥ 5 years), strong management, interpersonal and problem-solving skills; Strong medical and scientific communication skills (written and verbal)
•Solution oriented and collaborative team player; Considerable organizational awareness (e.g., interrelationship of departments, business priorities), including significant experience working cross functionally and in global teams.
•Basic clinical/scientific knowledge of clinical therapeutic areas. Solid computer technical skills (Word / Excel / Power point) and ability to learn new systems quickly.
million lives were touched by Novartis medicines in , 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.
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