Általános manager állások Külföldön (egészségügy, gyógyszeripar)

• 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.

• Own and achieve order and sales targets in the designated sales territory and accounts.
• Promote the full Leica Biosystems product and services portfolio through customer visits and relationship building.

• 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

Partner and develop ongoing relationships and value propositions within the C-suite at the HQ LNG as well as key stakeholders within the different accounts dedicated to the LNG (i/e Committee Members, Procurement, Medical Directors etc.)...

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 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

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

• 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....

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)...

• 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