Job Description Summary
Job Description Summary
Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!
Responsible for an innovative approach and independent planning and management of complex clinical research activities to demonstrate product efficacy and safety, and preparation of product registration dossiers in accordance with legislation, internal regulations, good practice and business objectives
Job Description
Major accountabilities:
- Active participation in development of complex formulations. Setting clinical strategy for projects. Independently plan, manage, and oversee complex clinical studies in accordance with project strategy, resources, timelines, and regulatory and professional standards.
- Lead operation related activities in close collaboration with Group head. Selection and management of activities performed by contract organizations; cost optimization; professional and regulatory compliance; efficient coordination and management of costs for activities performed by contract organizations.
- Lead, on-board, mentor and guide CD associate(s) and interns for clinical processes and compliance for day-to-day activities as per Sandoz standards and regulatory requirements
- Responsibility for GxP standard implementation and ensuring that these standards are trained on, known, and understood, and that implementation is controlled
- Ensures Self-Inspection and GCP audit readiness.
- Play active role as a member of the clinical development team to continuous harmonization, process improvement initiatives, knowledge sharing, and setting of the excellence framework for clinical research, as well as contributing to implementing the vision and strategy for Product development small molecule clinical development. Other tasks determined during the annual objectives setting process and by KPIs
- Other tasks as assigned by the supervisor, and tasks based on a specific appointment
Minimum Expectation:
- Minimum 8 years of experience in clinical development or associated fields
- Knowledge of pharmacy, pharmacokinetics, pharmacodynamics, bioanalysis, statistics and/or clinical trials.
- Experience in developing Clinical development Plans
- Solid knowledge of GCP and worldwide regulatory requirements related to assigned area
Why Sandoz?
Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health.
With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably.
Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported!
Join us, help us make healthcare fairer and faster.
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
#Sandoz
Skills Desired
Auditing, Clinical Monitoring, Clinical Research, Clinical Trials, Data Management, Global Project Management, Health Sciences, Lifesciences
