Rental manager állások, munkák klinikai kutató kategóriában

• Plan and Conduct GCP Audits: Develop a risk-based audit schedule covering all relevant areas, including investigator sites, vendors, and internal processes, to ensure adherence to GCP guidelines
• Oversee Corrective and Preventive Actions (CAPA) specific to GCP (internal or external)

• Strategic planning, execution, and oversight of international Phase I clinical trials in accordance with GCP/ICH-GCP guidelines, regulatory requirements (EMA/FDA), and internal SOPs
• Preparation, review, and approval of all relevant study documents in collaboration with external service providers

Clinical ManagerAbout the role:Acrostak is a global leader in health technology, committed to improving hundreds of thousands of lives worldwide and striving to make the world healthier and more sustainable through optimized manufacturing and innovation.We are looking for a Clinical Manager, which...

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

Management of safety operations incl. corresponding service providers, creation and maintenance of reporting rules (in collaboration with the department Global Safety Application Management) and license partner obligations with respective compliance outputs (e.g. KPIs, PSMF)...

Business Development in-Licensing ManagerThe Medicines Patent Pool (MPP) is a United Nations-backed public health organisation working to increase access to and facilitate the development of life-saving medicines for low- and middle-income countries. Through its innovative business model, MPP...

• 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

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

Business Development Manager - Pharma and CosmeticsThe Business Development Manager for the Pharma & Cosmetics segment will drive expansion of bNovate’s microbial water quality monitoring solutions within regulated production environments. The role focuses on identifying high-value opportunities,...