348607BR
Jul 25, 2022
Switzerland

Job Description

5600 scientists working on 340 discovery programs in 8 disease areas focusing on 90 new molecular entities makes Novartis a premier place to develop your career as a pharmaceutical professional. If you are curious, scientifically minded, detail oriented and want to positively impact society by speeding the delivery of novel therapies to patients, then look no further, NIBR is the place to be.

As a Compliance Excellence Officer (CEO) in the Translational Medicine Pharmacokinetic Sciences group, you will have the opportunity to make a difference. We are looking for professionals with expertise in bioanalytics, pharmacokinetics, and familiarity with quality & information management systems. The role is within NIBR at the Novartis Global Headquarters in Basel, Switzerland. If you have a collaborative nature, a commitment to teamwork and a focus on continuous improvement, we want you to apply. As a Compliance Excellence Officer, which is equivalent in level to a Principal Scientist, your responsibility will be to ensure the continuity of bioanalytical science through compliance and process excellence with scope spanning late discovery to post-marketing.

Your responsibilities will include but are not limited to:
• Support identification, overview and prioritization of compliance improvement activities to enhance regulatory compliance within global Bioanalytics.
• Identify areas of concerns/deficiencies and propose improvement or training.
• Lead the CRO oversight and governance in compliance with the Novartis SOPs
• Collaborate with Quality Assurance and Bioanalytics Leadership Team to support preparation, conduct and follow up of audits and/or health authority inspections. Oversee preparation and completion of compliance deviation / Corrective Action Plans, if any
• .Be Line function Applicability representative for Standard Operating Procedures (SOP) assignment and coordinate SOP revision and other process documents.
• Maintain expertise in regulatory guidelines for ICH, FDA, and other Health Authorities (HA). Point of contact providing consolidated feedback to HA on behalf of Global BA.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:
• MS PhD or equivalent in a relevant discipline
• Fluent English oral and written
• Significant experience relevant to this position in the pharmaceutical/CRO/related industry
• Strong scientific, process and operational background
• Fundamental understanding of bioanalytics and quality management systems and concepts


Join our Novartis Network:

If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:

https://talentnetwork.novartis.com/network

Why Novartis?

766 million lives were touched by Novartis medicines in 2021, 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!
NIBR
Translational Medicine
Switzerland
Basel
Research & Development
Full Time
Regular
No
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348607BR

Compliance Excellence Office – Pharmacokinetics (80-100%*)

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