Menedzser állások Külföldön (egészségügy, gyógyszeripar)

• 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

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 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)...

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)...

• 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

• Conducting sales calls and meeting with key decision makers to introduce/upsell our entire portfolio of products.
• Building rapport with existing clients and new.
• Ensure fast implementation and execution of strategies, projects and methods.

• Provide guidance on regulatory and quality requirements, including MDR and FDA requirements, for our in-house and our customer software projects
• Create technical documentation for our industry projects together with our software development teams

• 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

You develop, maintain, and continuously improve the Quality Management System in accordance with ISO 13485, MDR, and other applicable regulatory requirements...

Strategic Account Planning: Own and lead the development and execution of robust, insight-driven key account plans aligned with national brand strategy and local market dynamics....

• Manage all lifecycle stages of M&A/PMI projects from the Service perspective, including both Due Diligence as well as Post-Merger Integration projects
• Develop and apply upside potential & risk scenario assessment frameworks for Service

• 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

• New business acquisition
• Renewals of expiring contracts or new tender issued by existing customers as well price negotiations ensuring customers having the right prices
• Establish value propositions and build business cases
• Post‐sale involvement with customers

• 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 the commercial development of profitable lab testing services
• Lead and develop the lab organization
• Monitoring of the laboratory and all work carried out there, to ensure compliance with relevant internal procedures and regulations

Develop and execute the EMEA KOL strategy: Identify, recruit, and manage key opinion leaders, clinical experts, and influential practitioners to strengthen the company's educational and marketing impact in the region...

Development of product strategies for existing and new portfolios, including market research to identify innovation opportunities in lens technology and design, as well as defining product specifications and managing the product lifecycle...

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

• 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...