Németország állások, munkák klinikai kutató kategóriában

Management of projects from conception, development work, verification, manufacturing, validation and ultimately product commercialization, in accordance with Hygiena's Product Commercialization Process (PCP)....

• Batch record review for API and bulk product for monoclonal antibody prefilled syringes
• Assessment and documentation of product deviations, OOS, and changes
• Quality oversight for relevant service providers, including CMO's, laboratories, technical operations and supply chain

• Scientific lead and coordination of Critical Quality Attributes (CQA) evaluations and product characterization studies
• Representation of Analytical Science in the customer project teams, coordination of activities and implementation of the QbD strategy

The Division of B Cell Immunology studies the molecular and cellular mechanisms affecting the quality of immune responses to vaccination for malaria in preclinical models and humans. The work includes diverse immunological, molecular, cellular, and biochemical assays. In this role, you will plan,...

Definition and implementation of the clinical evaluation strategy for complex and challenging development projects focused on innovative microsurgical applications in the area of intra-operative visualization and digital imaging in neurosurgery...

Define and lead the global Clinical Affairs strategy for Brainlab's global surgery portfolio, ensuring alignment with product, regulatory and commercial objectives / teams...

• planning, management and organization of epidemiologic research projects in the area of molecular and genetic epidemiology (with emphasis on omics technologies)
• development of data analysis plans
• data analysis of complex data from phenotyping, genotyping, sequencing and other omics sources

• Accountability to lead teams within overall CMC development project(s)
• Drive strategies and activity within the team to support overall development plan.
• Establish good working relationships with internal and external stakeholders

• Overall medical and clinical strategy leadership for late-stage (Phase 2/3 and Phase 3 pivotal) development programs
• Medical leadership of clinical trial design and execution, including diagnostic and therapeutic radiopharmaceutical studies

Working independently in the areas of valve crimping, case management, pre-case planning, post-case management, 3 Mensio management, Therapy Awareness program management and clinical education programs...

In your new role, you will define and implement the global strategy for analytical development, supporting BI's pipeline from early research through candidate characterization and selection to drug product development and launch....

Deliver technical expertise in the development of container closure systems, including vials, prefilled syringes, and prefilled cartridges, by employing cutting-edge methodologies to conduct comprehensive analyses and evaluations of their protection, safety, compatibility, and performance attributes...