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 to provie partnership and compliance expertise to the process owners for the development and implementation of a comprehensive strategy for global, x-functional...
Responsible for the implementation of complex global regulatory strategies, obtaining and maintaining marketing authorizations for biologic products, and communication of general...
The Manufacturing Process Owner role is a Senior role in a newly forming team requiring in-depth technical and operational knowledge of aseptic Drug Product manufacturing...
The Director will provide regulatory support across the Therapeutic Areas including Infectious Diseases. Their support includes but is not limited to managing the regulatory...
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The Medical Affairs & Patient Partnership Manager provides medical and scientific support, usually focused on a specific franchise and country, externally - to the medical...
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...
Leading and coordinating multidisciplinary teams within diagnostic operations, leading and developing a team of four direct reports (Controller & Project Manager)....
Write and prepare clinical submissions documents within a team environment. Ensure critical review and interpretation of clinical efficacy and safety data for appropriate medically...
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...
Driving growth of Gilead’s HIV portfolio in the assigned territory; Represents Gilead’s products and services to a defined customer base within a specific geographic area...
Provide technical oversight of tech transfer activities; Coordinate local tech transfer activities by running weekly meetings, tracking actions and chasing action owners Track and...
Business Development that encompasses two primary activities, product portfolio selection and product portfolio management. Product portfolio selection is the identification of...
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...
Under the direct supervision of the Senior Procurement Specialist, with cross-functional coordination by Programme Manager (Health), the Pharmacist/Pharmaceutical Specialist will...
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...
As a QC/MW Manager, you will be responsible for the day-to-day operations in the QC/MW team, including scoping of tasks, resource allocations, and line management of assigned staff...
Provide PV and risk management expertise to internal and external customers, safety expert for product, maintain knowledge of product, product environment, and recent literature;...
Prepare global regulatory strategies for in vitro diagnostic (IVD) products, direct and prepare regulatory submissions as required for global approvals for in vitro diagnostic...
Responsible for an established team of experienced industry and technical experts, your role will be to lead the discovery and development of innovative antibacterial drugs and the...
As TMCP Precision Medicine Lead you will advise project teams on Precision Medicine/CDx strategies, e.g. regarding patient selection strategies, clinical trial design and...
Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements, may manage QA personnel, including organizing and...
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...
To proactively lead the quality team and ensure the site meets all external regulatory, customer and internal stakeholder requirements with regard to quality management systems and...
The Director, GMA - Pompe will lead Medical activities in the Pompe disease space and will be working closely with the Avaglucosidase launch team. This person will be expected to...
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 primary role of the Aseptic Control Lead will be to support Drug Product Filling Operations by providing Microbiological, Technical and Compliance support to ensure Aseptic...
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...
You will be responsible for liaison with leaders and healthcare professionals in academic and clinical centers for scientific exchange and data generation to ensure our therapies...
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...
We are currently looking for a Director, High Throughput (HT) Technologies to join our R&D biologics team. Our Bio R&D team is selecting and implementing an arrange of state of the...
In this exciting role, you will support clinical trial and product license applications for various CMC (Chemistry, Manufacturing and Control) biological projects for customers....
Setting financial and operational performance targets; preparing annual operating plans to establish profitability, ensuring delivery of capacity and development of operations...
In your new role you lead and coordinate activities related to above areas; You represent your area as a team member within the respective development teams; As project team member...
This position is responsible for providing strong scientific support to the phase appropriate development of drug substance manufacturing processes. This role requires application...
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...