Senior analyst állások, munkák klinikai kutató kategóriában

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

As a Senior Product Portfolio Manager (f/m/x) within ZEISS Meditec AG, your role is similar to and in strong collaboration with product management for the single products contributing to your clinical workflow solution...

• Responsible for the quality control of clinical trials phase I to IV, both nationally and internationally
• Ensure study sites conduct clinical trials in accordance with the protocol, ICH-GCP guidelines, and the applicable regulations

• 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

• Analyse the pharmaceutical R&D landscape, including development and manufacturing technologies related investment trends within MPP therapeutic in licensing target areas
• Generate market intelligence and scientific/commercial analysis on licensors, targets and disease areas

Lead technical investigations for customer complaints and product CAPAs assigned to R&D, evaluate technical issues that occur during daily use of our systems in hospitals and act as key reference within the R&D team...

• 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

• 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