Stability monitoring expert

Job title: Stability monitoring expert

• Grade: Level 2
• Hiring Manager: Éva Demeter
• Location: Budapest
• Job type: Permanent, Full time

About the job

Our Team:

Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions.

As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health.

The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams by acting as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines.

Main responsibilities:

• Check conformity against acceptance criteria in the protocol, ensuring statistical results fall within the permissible range
• Conduct initial data interpretation based on statistical analysis outcomes
• Include data and graphs created by the statistical tool used
• Connect with site-specific SMEs to review, discuss, and interpret analysis results, determine if objective of study has been met
• Identify and report deviations, concluding on their impact to the study
• Summarize findings and write report in accordance with regulatory commitments using CMS guidelines

About you

• Experience: >3 years professional experience in pharmaceutical quality report issuance
• Soft skills: Proficient in problem-solving, attention to detail, and good organizational skills. Ability to work collaboratively with cross-functional teams in a flexible and proactive manner. Strong analytical skills. Agile thinker and learner, adaptable to complex & dynamic environments
• Technical skills: Thorough understanding and practical experience in applying ICH guidelines to ensure compliance in stability studies & quality risk management
• Other skills: LIMS, Word, Excel, statistical software, GxP experience, stability regulation
• Education: Master's Degree in a scientific background or similar area
• Languages: Excellent English communication and writing

Why choose us?

• An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.
• An attractive, market-oriented salary and cafeteria benefits.
• Flexible home office policy, with a possibility to work up to 60% of time from home / where you can easily schedule your office days.
• Work from an "Office of the Year 2020" finalist office.

Pursue Progress. Discover Extraordinary.

Progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let's pursue progress. And let's discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Discover our Code of Conduct, that serves as the moral compass that guides us when chasing the miracles of science to improve people's lives. Please ensure to have read this document, before applying.

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