You will be directly involved in daily business activities and work on tasks within different projects, you will gain insights in all important areas and will be given more and...
The job holder for this role is responsible for managing business relationships with defined stakeholder groups and senior leaders in Development / Clinical Functions for the...
Responsible for the implementation of complex global regulatory strategies, obtaining and maintaining marketing authorizations for biologic products, and communication of general...
The Director will provide regulatory support across the Therapeutic Areas including Infectious Diseases. Their support includes but is not limited to managing the regulatory...
The Medical Affairs & Patient Partnership Manager provides medical and scientific support, usually focused on a specific franchise and country, externally - to the medical...
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Successfully oversee and monitor CRAs in a matrix environment with a focus on quality and timely deliverables; address issues with appropriate team and line manager; direct...
Ensuring GCP/GVP quality & compliance oversight Providing strategic direction and leadership to R&D and Medical Affairs Departments under a Quality point of viewDeveloping the...
Cooperation and Management of external service providers in the field of clinical research; Preparation and review of study-specific documents (IB, protocol, CRF, CSR, …);...
As Group Head Statistical Programming, you will play a key role in providing leadership and strategic inputs for all statistical programming projects within your group (rare...
The Clinical Trial Manager is the Regional or Global Protocol Lead in Regional Clinical Trial Operations (RCTO) responsible for the coordination of clinical operations required to...
This person will actively participate/lead a broad range of IAI (Dermatology/Ruxolitinib Cream as the key priority) medical affairs activities such as launch preparation & strategy...
In this vital role you will be the primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up to close out (CSR/Archival) at a...
Manages standards and oversees the monitoring of outsourced processes, investigates and leads the follow-up of discrepancies, manages the monitoring of supplier performance via...
Provide PV and risk management expertise to internal and external customers, safety expert for product, maintain knowledge of product, product environment, and recent literature;...
As a CRA II, you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of...
Prepare global regulatory strategies for in vitro diagnostic (IVD) products, direct and prepare regulatory submissions as required for global approvals for in vitro diagnostic...
The Associate Clinical Trial Manager is the Regional Clinical Trial Operations individual responsible for the coordination of clinical operations required to initiate, execute and...
The Manager, Clinical Data Management performs activities pertaining to the conduct of Phase I - III clinical trials in accordance with ICH/Good Clinical Practices (GCP) and other...
The Senior/Project Manager (Neurology and Internal Medicine) has the overall responsibility for managing projects in accordance with company policies, SOPs, regulatory requirements...
The Senior Project Manager has the overall responsibility for managing projects in accordance with company policies, SOPs, regulatory requirements in addition to financial and...
The Senior Medical Director drives the design, safety monitoring, and data analysis of the Company’s late-phase clinical trials in endocrinology. As such, the Senior Medical...
The GCP/GVP Quality Manager will provide GCP/GVP Auditing and Quality Management support to Santhera’s clinical development program and marketed products to ensure Santhera’s...
Manage and develop the regulatory affairs development team, consisting of global regulatory leads (GRLs) located in Europe and US; Provide guidance and coaching to individual team...
The Regulatory & Compliance Business Officer will work alongside our UK Team, ensuring licensing and legal compliance of SFI Health products. The role will also support...
In this exciting role, you will support clinical trial and product license applications for various CMC (Chemistry, Manufacturing and Control) biological projects for customers....
As the Regulatory Affairs Senior Manager, you will manage and support a team of managers and employees of different levels. You will be responsible for developing and implementing...
A Sr. CRA may also have the role of Associate CTM which is primarily responsible for management of some Seagen clinical trial sites. This role focuses on performing all activities...
Perform clinical research project management activities including resource planning, timelines, and milestone management. Coordinate and manage multicentric submissions to...
The position purpose is to address the very high unmet need for organ targeting in heart and kidney diseases and to achieve major advances in the targeting of drugs to tumors in...
The Medical Director is the Senior Medical Leader for Moderna in a cluster of countries typically integrated by a core market (i.e. Germany, France, the UK, Italy, Spain) and a...
Implement and execute to a high standard all aspects of assigned clinical studies from designing and planning through to conducting and reporting. Oversee and manage the day-to-day...