Maneger állások Külföldön (egészségügy, gyógyszeripar)

• Analysis of potential markets outside of Europe including market access feasibility.
• Validate the potential of Cardioplexol by country/region considering regulatory and patent specifications.
• Define a segmentation map considering market potential and technical/access metrics.

• A high-ownership role at the center of a lean program, with direct impact on key milestones.
• Close collaboration with senior scientific leadership and a network of top-tier external partners (Research Institute/CRO/CDMO/regulatory/quality).

• Focus of this position is supporting our rapidly developing in Diabetes Care (active and connected devices)
• Manage the development and implementation of RA strategies
• Support and prepare product submission documents with main focus on US
• Partner with business stakeholders on different levels

• Risk Identification & Assessment - Analyze risks related to product development, manufacturing, post market, useability, biocompatibility, cybersecurity, vigilance, compliance, etc..
• Implementation of Risk Controls - Develop strategies to minimize risks and improve processes.

Plan, Conduct, and Follow Up on Pharmacovigilance Audits including oversight and training of external service providers and consultants (for audits), ensuring adherence to company standards and regulatory requirements...

• Plan and Conduct GCP Audits: Develop a risk-based audit schedule covering all relevant areas, including investigator sites, vendors, and internal processes, to ensure adherence to GCP guidelines
• Oversee Corrective and Preventive Actions (CAPA) specific to GCP (internal or external)

• Strategic planning, execution, and oversight of international Phase I clinical trials in accordance with GCP/ICH-GCP guidelines, regulatory requirements (EMA/FDA), and internal SOPs
• Preparation, review, and approval of all relevant study documents in collaboration with external service providers

Act as the primary IT business partner for the R&D organization, aligning IT initiatives with R&D strategy, priorities, and the strategic demand management process....

• 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

• Lead strategic relationships with CMOs to improve cost, quality, delivery performance and innovation (annual spend $60-70M)
• Conduct regular business reviews (SRM) and monitor KPIs, performance metrics, and contractual compliance

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 the Site-Launch activities and associated teams for internal and external sites and development projects...

The role combines two aspects: the Technical Support to Regions (TSR-API), which entails addressing any Regulatory Affairs and Quality Assurance needs that arise in the assigned region (EMEA), and the Technical Support to Manufacturers (TSM-API), which involves acting as the central point of...

• Become an expert in Brainlab's orthopedic planning and endovascular navigation portfolio
• Demonstrate solutions both in person and online, showcasing clinical value through interactive demos, workshops, and webinars

• 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

Lead and develop a team of 7–10 NPI Project Managers based in Switzerland and the US, fostering a culture of accountability, collaboration, and continuous improvement...

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)...

• Act as the clinical leader and primary clinical representative for global programs, ensuring high quality and speed of functional deliverables.
• Develop a clinical vision for addressing unmet medical needs, considering the molecule's scientific hypothesis.

• Provide medical leadership for the Near Patient Program in Germany, ensuring effective, compassionate, and compliant service delivery.
• Serve as the primary liaison between local Near Patient staff, military medical providers, and host-nation healthcare facilities.