Senior reporting analyst állások, munkák klinikai kutató kategóriában

• Lead and coordinate CMC development activities for innovative small molecule anti-infective drug candidates
• Drive late-stage CMC readiness for key clinical and regulatory milestones, including Phase 3 preparation

• 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

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