Counsellor állások, munkák egészségügy, gyógyszeripar területen

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

Collaborate closely with Translational Science Leads (TSL), Clinical Operations, Biostatistics/Bioinformatics, and Data Management teams to execute translational science strategies in clinical trials....

• 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)...

• Responsible for project management of NIS and IIS
• Manage the publication processes related to clinical studies conducted by Octapharma
• Product reviews for submissions to international health-authorities
• Response to internal scientific questions
• Response to external medical enquiries

• 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

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

• 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

Szociális diagnózis készítése a Szt.64/A § szerint az 1993.évi III.tv és az 1997. évi XXXI.tv, valamint a 15/1998.(IV.30.) NM rendelet vonatkozó rendelkezései, illetve a szakmai protokoll és a módszertani útmutató alapján szociális diagnózis felvétele a Budakeszi járásban Esetmenedzseri feladatok...

• 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

• Develop clinical trial strategies, shaping study designs based on regulatory requirements, competitive insights and company's research interest.
• Give insights into clinical data sets and evidence for our company's products to internal stakeholders.

The Division of B Cell Immunology studies the molecular and cellular mechanisms affecting the quality of immune responses to vaccination for malaria in preclinical models and humans. The work includes diverse immunological, molecular, cellular, and biochemical assays. In this role, you will plan,...

• Homeoffice
• Team spirit
• Family atmosphere
• Training opportunities
• Work-life balance / Family-friendliness

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...

• Collaborate with cross-functional teams including IT, Quality Assurance, and Operations to ensure documentation and validation of systems according to internal procedures
• Ensure compliance with internal and external regulatory requirements and guidelines
• Maintain the inventory of software applications

• Identification of patenting opportunities, drafting of patent applications and development of suitable filing strategies
• Handling of all stages of patent prosecution, including requesting SPCs/PTEs where applicable
• Supporting the Patent Conflicts Team as needed

• Drive and complete reimbursement applications for the Vibrant product portfolio
• Build and check health economic models that clearly demonstrate product value by using appropriate software tools

• Responsible for performing laboratory-based activities and processes
• Tracking, inventory, sample processing, and transport of biological samples from clinical and non-clinical trials
• Manage associated metadata, and ensuring that lab activities fulfill customer needs

Ensure local Medical Excellence & Operations activities comply with all AbbVie processes, the Code of Business Conduct, ethics, regulatory requirements, and local laws...