Apr 16, 2022

Job Description

1886! We have more than 130 years of experience treating patients. Sandoz, a division of Novartis, is a global leader in generics and biosimilars and is committed to playing a leading role in improving access to medicines worldwide.
Global Medical Development Specialist are individuals with a comprehensive understanding of the relevant technical requirements for electronic registration submissions. They technically prepare and organize the clinical, non-clinical and medical parts of the registration dossier in electronic submission systems under supervision of the responsible (senior) global medical development manager during the product life cycle and in close collaboration with the respective regulatory departments (RCCs, DRCs, MRCs).

Your responsibilities include, but are not limited to:

• Technical compilation and organization of the clinical, non-clinical and medical parts of application dossiers for development projects and throughout the product life cycle according to international regulatory requirements and Sandoz internal standards under supervision of the (senior) global medical development manager.
• Prepares above mentioned parts of the respective parts of the application dossier in Sandoz electronic submission systems (including QC check of the dossier in Sandoz electronic submission system) and archives in folder structure in the appropriate hard drive or as hardcopy if required.
• Supports global medical development in their business, especially in correspondence, logistics and office management aspects, placing orders in SRM
• Self-contained organization and administrative compilation of the necessary medical documentation for national submissions (incl. ROW). Collaborates with external experts for compilation of medical submission documentation
• SRM/purchase orders, administrative contract management, point of contact for indirect purchasing etc.
• Coordinates deficiency letters of national submissions and escalates to global medical development manager as necessary
• Support QMS related activities: Manages training matrix and allocation of training in respective training system (Up4G); support of training responsible person; acting as SOP manager
• Supports evaluation and reporting of key performance indicators, and metrics; administrative support for budget planning and resource utilization. Other tasks, as directed by the supervisor, or based on specific appointment, or determined during the annual objectives setting process, or by relevant key performance indicators.

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

• Academic degree in medicine, pharmacy or life-science is required to ensure the incumbent has the necessary theoretical and practical knowledge to lead the science. Excellent in English, both written and spoken.
• Pharmaceutical and regulatory document management .2-4yrs of pharmaceutical or biopharmaceutical industry experience and knowledge of the regulatory environment area of significant benefit.
• Collaborative, team oriented approach, and will be adapt at developing and supporting relationships across an organization. Experience being an active contributor to cross-functional teams and/or working in matrix organizations will be essential.
• Ability to see a broader picture; attention to detail; high quality, critical thinking, process and performance orientated; anticipates issues and implements contingency plans to avoid missed deliverables/expectations; prioritizes activities and projects, in order to better spend own time for what would provide the optimum return to the organization.
• Exercises good judgment on regulatory, legal, quality and technical related compliance issues; ensures compliance obligations are met across all areas of responsibility.
• Positive and ‘can-do’ approach; biased towards finding solutions and win/wins; responsiveness and flexibility. High Integrity; trustworthy; strong compliance and quality mind-set. Excellent team playing and communication skills; strong sense of ownership and accountability

Why consider Sandoz?
Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?

The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.

Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.

Imagine what you could do at Sandoz!

Commitment to Diversity & Inclusion:
Sandoz, a Novartis company, embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Product Dev SZ
Hyderabad, AP
Research & Development
Full Time
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Global Medical Development Specialist

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