337907BR
May 05, 2022
Mexico

Job Description

28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently.
Your key responsibilities:
• Ensure the preparation of matrix for training for each member team and ensure compliance with local and global procedures. Act as Training Responsible Person for Clinical Trials Team. •Ensure the review, update, and preparation for submission all Prescribing Information for both new products and portfolio maintenance
• Review and prepare for submission all Promotional Materials required for current portfolio. Prepare and update local procedures or working instructions in accordance with global guidelines (SOPs), international guidelines or local regulations in compliance with Good Clinical Practices. • Attend local and global audits and participate on the CAPA's preparation.
• Ensure compliance with local regulations applicable to the promotional materials generated for the promotion of Sandoz portfolio, but also for those products under Sandoz's commercial agreements with other companies.
• Responsible for review and approvals for promotional materials ensuring adherence to P3 guidelines and local procedures and laws.
• Responsible of management issues related opening and closing records in the electronic applicable system (deviations, change control, quality events, preventive and corrective actions) for DRA&CT.


You’ll receive:
A total compensation package that includes a competitive salary, performance bonus, learning platforms, pension plan, major medical expenses, flexible working environment, global employee recognition scheme, flexible benefits, parental leave, collaborative and empowered culture, development opportunities and so much more.

Why Sandoz?

769 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 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 sandoz!

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

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

Experience on quality assurance systems
• Ability to apply and share the knowledge on processes and procedures to ensure compliance and
achievement of quality systems.
• Strong knowledge of quality assurance systems for pharmaceutical products and clinical trials.
• Medium knowledge of Good Clinical Practices
• Medium knowledge for regulation of medicinal products as Generics.
SANDOZ
Commercial OPS SIR SZ
Mexico
Distrito Federal
Research & Development
Full Time
Regular
No
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337907BR

Regulatory Affairs and Doc Expert

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