30 May, 2022
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 KEY RESPONSIBILITIES:
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.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
WHAT YOU’LL BRING TO THE ROLE:
- 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
Apply through this Link