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As our new Associate Director RA Device, you will be driving the regulatory strategy for device constituent parts of combination products and use your device regulatory experience...
Monitor and analyze the impact of emerging or revised laws, regulations, enforcement actions and other changes that impact the manner by which the clients' products are regulated...
Manages the process to verify, through risk-based independent audit, compliance of PV activities with national/international regulations and guidelines on Good Pharmacovigilance...
This role serves as a close business partner and facilitator of regulatory activities and is expected to contribute to developing sound regulatory strategies globally. The role...
Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product...
Create and Review regulatory documentation for Drug, Device and Combination product renewals with major focus on Medical Device renewals; Track status and progress of regulatory...
This position is responsible for the study-level management (prior to submitting to IRB/EC to closeout) of clinical studies, including preparation of applicable clinical study...
Develop and maintain excellent thought leader relationships in the field of rare disease specifically Fabry Disease, Pompe Disease and Batten Disease; Lead on medical initiatives...
As an (Associate) Director, Global Regulatory Affairs Project Lead you will join our Global Regulatory Affairs organization. In this capacity, you will assume responsibility for...
Director, Clinical Research Scientist is responsible for working with the physicians within Clinical to provide clinical research support for programs as assigned by phase or...
Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic tests and other devices to enhance the value of our oncology pharmaceutical...
Activities include but are not limited to, quality control of PV tasks fulfilled by DSE (EU headquarter office), EU affiliates, CROs and license partners and proactively monitors...
As a Senior Project Manager, you will be joining the world’s largest & most comprehensive clinical research organisation. You will lead cross functional study team (core and...
The Senior Clinical Scientist will lead the scientific and operational elements of the clinical development plan for one of the ProQR pipeline projects, proactively engaging key...
The ideal candidate will have the ability to lead a team, enhance operational processes, and play a key role in the strategic planning of an innovative biometrics CRO. You are...
Provides direction and guidance to the PV Case Management function to ensure streamlined and efficient process, and fulfillment of support needed from other PV functions as well as...
The Director guides the project teams to design and implement clinical studies at high quality and in a time and cost-effective manner in line with the department and corporate...