Job title: Regional Stability Monitoring Expert
- Location:Bogotá, Colombia
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as Regional Stability Monitoring Expert within our team, will be to deliver and support 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.
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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: >5 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: Bachelor's degree(preferably inEngineering,Pharmacy, Chemistry, Biology, or related field)
- Languages: Excellent English communication and writing; additionally, at least one of the following: Spanish, Portuguese or French
Why choose us?
- Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
- You'll be part of leading the first experiences a job seeker has with Sanofi and ensuring it is best-in-class and driving conversions.
- You'll be part of a truly diverse cross-cultural team and can have real business impact.
- Flexible working policies, including up to 50% remote work.
- Private medical care, life and health insurance, and gender-neutral paid parental leave
- Colombia is one of Sanofi's key locations for new talents, having a big footprint with the Bogota HUB and its best-in-class operation.
- Mexico and Argentina Play an instrumental part in creating best practice and innovation within our 3 vaccines production plants.
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!
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