Counselor állások, munkák egészségügy, gyógyszeripar területen

• 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,...

Execution of consulting projects with a focus on developing market access and dossier strategies, including preparation of corresponding workshops, and participation in oral hearings with relevant authorities...

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...

• Ensure Data Management activities comply with internal standards and regulatory requirements (e.g., ICH-GCP)
• Support the development and testing of (e)CRFs and data review tools
• Contribute to the creation and maintenance of Data Management documentation

• Analysis, integration, and interpretation of high-dimensional omics datasets in translational research
• Bioinformatic analysis of:
• Bulk RNA sequencing
• Single-cell and single-nucleus RNA sequencing
• CITE-seq
• ATAC-seq
• NGS-based datasets
• Metabolomics and proteomics data

• 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

• Provide medical oversight of ongoing clinical trials, including safety review
• Contribute to protocol development, amendments, and clinical documentation
• Interpret and review clinical trial data
• Support CRF design to ensure high-quality data collection

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

Project Leadership & Strategy: Act as the technical lead for instrument hardware product care team, driving workpackage planning, implementation and resource allocation with line management...

Develop and execute the external innovation and growth strategy in alignment with corporate objectives, in close collaboration with internal business stakeholders and in accordance with established governance processes...

• Act as interface to the analytics representative
• Approve corrections in ProNas and create label data
• Prepare projects (special materials for aliquoting, check packing lists, folders, etc.)
• Assist with and execute trainings
• Issue reserve and stability samples
• Order laboratory materials

• Responsible for the quality control of clinical trials phase I to IV, both nationally and internationally
• Ensure study sites conduct clinical trials in accordance with the protocol, ICH-GCP guidelines, and the applicable regulations

• 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.

QMS Process Management: Oversee the full lifecycle of changes for PTT owned QMS documents, from change initiation and action item assignment to responsible owners across the global network, driving completion and secure the final "approval to execute" before documentation is made effective...

• You are responsible for the spectroscopy product portfolio (SPG - Strategic Product Group) consisting of two product portfolios.
• You drive the business forward based on agreed product roadmaps and budgets including profit & loss responsibility.