ASTELLAS PHARMA EUROPE is looking for employees for positions:
quality assurance manager
Language
english
Requirements
advanced degree in related disciplines
previous experience in managing staff
experience in these disciplines in the pharmaceutical industry
regulated computerized systems auditing experience in a pharmaceutical manufacturing or clinical development environment required
ability to represent the company to external stakeholders during vendor audits and interacting with regulatory agencies
experience in developing and maintaining effective relationships with internal and external stakeholders for process improvement and issue resolution project teams
collaborative skills to facilitate, manage, and work within project teams across departments and global organizations
in-depth knowledge of GxP regulations and computerized systems in GxP regulated environments, preferably for pharmaceuticals, relating to product development, combined with broad knowledge of quality principals and industry trends
Responsibility
report status of validation projects to management
assist TDQA management to plan and manage internal and external resources to execute the TDQA validation oversight and audit programs
manage programs and resources necessary to support assigned projects
manage, coordinate, plan, and administrate the TDQA program to oversee the computerized systems validation program and ensure reviews of computerized system validation documentation is completed to ensure compliance with Astellas policies and procedures
interacts with functional teams to assist QA management to identify QA activities and resources necessary for review and support of project related initiatives
identify, develop, facilitate, and manage process improvement initiatives that relate to electronic system development life cycles, validation processes, IT systems/processes, data integrity control processes, and regulatory compliance assurance processes throughout Astellas
serve as QA representative on assigned project teams associated with software validation projects and process improvement initiatives to provide guidance, direction, and support regarding quality assurance and regulatory compliance, to resolve compliance issues, report to management, and to ensure completion of quality related action items
ensure and facilitate compliance with global Electronic Records / Electronic signatures regulations and provide quality and compliance guidance in areas of continuous improvement, innovation, and validation
Education
bachelor of Arts/ Bachelor of Science degree, or equivalent
clinical lead
Education
phD or PharmD with a fellowship in clinical pharmacology or equivalent
Requirements
extensive professional experience in the pharmaceutical industry
working knowledge of assigned therapeutic area, biomarkers, bioanalytical methods, immunogenicity
have thorough understanding of early development, clinical methodologies, POC, and clinical endpoints within a specific therapeutic area
experience integrating modelling and simulation activities pharmacokinetics, exposure-response and physiologically based PK) to support the clinical pharmacology plan
expert knowledge of clinical pharmacology in drug development, with a strong scientific and strategic mindset and experience with clinical dose setting and pharmacokinetic/pharmacodynamic relationships
Responsibility
leading cross-functional sub-teams necessary by phase of development to achieve Clinical Pharmacology goals
providing effective oversight of clinical pharmacology aspects of clinical trials
participating in cross-functional discussions and collaborating with individuals across disciplines; mentoring junior members
reviewing clinical protocols, analysis plans, study reports and regulatory submissions
developing high quality clinical pharmacology plans and content for global regulatory submissions
representing the department and providing subject matter expertise on cross-functional project teams starting with candidate nomination Good Laboratory Practice Toxicology) through approval and post marketing
you will be part of an inclusive team that works to develop innovative therapies for patients
clinical engineer
Education
bachelor of Science degree in Computer Science, Information Systems, Data Science, or equivalent
Requirements
substantial years of relevant experience working in data architecture, engineering roles, or related roles within a healthcare/Life Sciences industry
expertise in ETL, data modelling, and data integration techniques
proficiency in programming languages commonly used in RWD data ingestion, such as Python, and Django framework
excellent communication and interpersonal skills, enabling effective collaboration with cross-functional teams, business stakeholders, and technical experts
expertise in working with web technologies such as HTML, CSS, JavaScript, and AJAX Strong command in RESTful APIs and web services integration. Knowledge of database management systems, particularly PostgreSQL or MySQL
Responsibility
strong knowledge of RWD assets including data sources like IQVIA, SYMPHONY, and various other OMICS sources
strong proficiency in Python and Django framework including experience with web technologies such as HTML, CSS, JavaScript, and AJAX
understanding of RESTful APIs and web services integration
additionally, Familiarity with deployment tools such as Docker, Heroku, AWS, and Azure
knowledge of database management systems, particularly PostgreSQL or MySQL
responsible for data operations on AWS architecture. Activities include creating and monitoring the data load ETL processes, ensuring data quality, automation of the loads, and continuous improvement
collaborate with Advanced Analytics Solution teams to identify required technology architecture needs to design and implement a solution delivering near-term impact and aligned with long-term strategies
manager
Education
BS in Computer Science, Informatics, or Life Science discipline
Responsibility
the position is responsible for the end-to-end technical implementation and execution of eCOA/eSource capabilities in a study
this role with work with clinical study teams, eCOA/eSource service providers, and translations service providers to plan for on-time delivery of all study-related eCOA/eSource systems
this role encompasses assessing risks and determining mitigations; defining data collection, reporting, and mapping requirements; establishing study level dataflow, technology/app and device deployment; user acceptance testing; data reconciliation, data change oversight and archival activities
Requirements
previous experience with eCOA implementation and delivering eCOA/eSource process capabilities at the clinical study level
established processes for cross-functional coordination for eCOA/eSource implementation in collaboration with Study Teams, eCOA/eSource service providers, and translations providers
demonstrated previous experience in pharma or CRO industry in either an eCOA or relevant Data Management role and solid knowledge of the Clinical Development Process
strong and demonstrated foundational DM skills in multiple drug development programs, inclusive of all activities through regulatory submission
experience in ensuring that all supporting operational documentation for studies/systems is maintained in accordance with processes to ensure quality, traceability, and regulatory compliance