Senior manager állások, munkák klinikai kutató kategóriában

• 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

• Play an important role within in a multidisciplinary team in the development of new and complex products / segments / features and in the management throughout the entire life cycle
• Create product visions and/or strategies independently for complex products / segments / features

Responsible for global Supply Chain activities for Investigational Medicinal Products (IMPs) of national and international Phase I-IV clinical trials in the Therapeutic Area General Medicine...

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)...

• Drive innovation by evaluating and continuously advancing therapies through aerosol inhalation
• Communicate scientific insights effectively and foster strong interdisciplinary collaborations to ensure successful translation into clinical practice

• 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

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

• Ensure Data Management activities comply with internal standards and regulatory requirements (e.g., ICH-GCP)
• Support the development and testing of (e)CRFs and data review tools
• Contribute to the creation and maintenance of Data Management documentation

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...

• 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

Create and/or hold scientific presentations, lectures, training courses, speaker decks, FAQ documents etc. with targeted content for the respective stakeholders...

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...

• 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

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