Sap junior tanácsadó állások Németországban (egészségügy, gyógyszeripar)

• 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

• Implement and validate state-of-the-art sequencing technologies (short-read and long-read) for diverse medical and scientific applications
• Establish and further develop an innovative metagenome sequencing platform for clinical diagnostics and hospital hygiene

• 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)

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...

Provide comprehensive In-patient clinical case management for a patient where they will be completing status reports upon admission and whilst the patient remains admitted to the provider....

Provide comprehensive In-patient clinical case management for a patient where they will be completing status reports upon admission and whilst the patient remains admitted to the provider....

• Design and execute experiments for purification of recombinant proteins
• Analyze and interpret data to guide process development and troubleshooting
• Collaborate cross-functionally with other RnD teams
• Contribute scientifically to the project progress, lead project discussions and development

• 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

• Providing ready to implement vision science concepts for development of digital measurement / digital fitting solutions
• Self-organized, constantly screening, analyzing, monitoring and testing of latest global developments and industry trends in vision science

• 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

• Maintain and further develop our QMS in line with EN ISO 13485 and MDSAP
• Create, update, and improve procedures, forms, and training materials
• Plan and deliver training on procedures and regulatory requirements
• Lead and oversee CAPA initiation, processing, tracking, and review

Unterstützung innerhalb der F&E-Abteilung/Einführung neuer Produkte (Neuproduktentwicklung und Innovation) und anderer geschäftskritischer und/oder umsatzfördernder Maßnahmen von der Planung bis zur Kommerzialisierung...

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

• Wartung- und Reparaturarbeiten an Hologic Produkten durchzuführen
• An Planungen von Installationen teilzunehmen
• Installation von Geräten kundenseitig durchzuführen
• Kontakt mit IT-Abteilungen der Kunden aufzunehmen und Unterstützung bei der Problembehandlung von Informationssystemen zu gewährleisten

• Collaboration on S1 and S2 work, including work with virus-containing material after appropriate training
• Cultivation and handling of cells, including work on a larger scale up to 25L (working with various bioreactor systems)

Creation, editing, and review of all quality documents (DEV, CAPA, CCO, maintenance completion reports) in accordance with SOP specifications...

• Global pharmacovigilance product responsibility for the medicinal products
• Monitoring of the benefit-risk profile
• Signal management: signal detection, signal validation, signal evaluation
• Risk management: preparation of risk management plans, supervision of risk minimization measures

Provide comprehensive In-patient clinical case management for a patient where they will be completing status reports upon admission and whilst the patient remains admitted to the provider....

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)...