Manager deputy állások, munkák klinikai kutató kategóriában

• Take full responsibility for the product portfolio throughout its entire lifecycle - from concept to phase-out
• Derive market and customer needs and translate them into clear product requirements and strategies

Develop and manage clinical project plan, timelines, and budgets end to end; clinical research, through pre-clinical evaluations, clinical trials and publications, to user guidelines and post-market evidence generation....

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

• 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

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)...

• 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...

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...

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...

• Analyse the pharmaceutical, biotech, cosmetics, and personal-care manufacturing markets to identify trends, growth opportunities, and emerging customer needs.
• Help develop and execute segment-specific go-to-market strategies.
• Map regulatory landscapes (e.g., GMP, ISO standards).