Katalyst Healthcares & Life Sciences

Responsibilities:Design code and test SAS programs used to generate CDISC SDTM & ADaM domains and tables listings & figures outputs.Perform analyses defined in the statistical analysis plan as well as ad hoc analyses as requested.Validate CDISC SDTM and ADaM data sets by using المزيد...

Responsibilities:The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS) Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products including regulatory responsibilities in associated change control and المزيد...

Responsibilities:Create new 3rd party supplier documentation including design specifications labelling design drawings etc. for peritoneal dialysis disposable sets.Create modify and maintain design history files.Perform change control assessments.Work closely with project manager and المزيد...

Responsibilities:Lead the creation of the Data Review and Cleaning Plan and development of the data cleaning strategy. Provide oversight of the data validation plan and provide DM insight to maximize the data validation strategy.Review CRFs to ensure alignment with protocol; lead and المزيد...

Responsibilities:Design Verification Support:Review and support design verification protocols and test reports.Ensure compliance with internal design verification design control equipment control and risk management procedures.Assist cross-functional teams to complete design verificat المزيد...

Job Description:The Data Manager Data Management Oncology Early Development (OED) is a member of the Data Management and Analysis team responsible for supporting the successful delivery of data and processes conducted by CROs. This individual will collaborate closely with the Data Man المزيد...

Responsibilities:Regulatory / V&V / Quality Assurance Engineer with 10-14 Years of experience.Knowledge of Design History file Device History Record and Device Master Record documents.Proficiency in Project management and execution.3-6 years of experience in DHF gap analysis / rem المزيد...

Job Description:This section focuses on the main purpose of the job in one to four sentences.Technical lead for DHF structure within sustaining engineering for disposable medical devices.Responsibilities:This section contains a list of primary responsibilities of this role that accoun المزيد...

Job description:The Medical Writing Word Processing Coordinator is responsible for formatting proofing and completion of Clinical Protocols Clinical Study Reports Investigators Brochures and other related clinical regulatory documents. Provides document formatting support to Medical W المزيد...

Responsibilities:Develop implement and maintain software quality assurance processes for non-product software used in medical device development.Ensure adherence to regulatory standards (FDA ISO 13485 IEC 62304) and industry best practices for non-product software.Support audits and i المزيد...

Job Description:The Quality Assurance team within the Worldwide Operations Manufacturing department is seeking an enthusiastic results-oriented and experienced Quality Assurance Specialist to join our organization as a Remote Worker.The candidate will be responsible for supporting the المزيد...

Responsibilities:Manage end-to-end delivery of data management services concurrently for single/multi-service projects with little-to-no guidance ensuring quality deliverables on time and within budget to customer satisfaction.Provide comprehensive data management expertise to Clinica المزيد...

Responsibilities:Regulatory / V&V / Quality Assurance Engineer with 10-14 Years of experience.Bachelor of Engineering / Diploma in Mechanical or equivalent.Knowledge of Design History file Device History Record and Device Master Record documents.Proficiency in Project management a المزيد...

Job Description:This position assists in the establishment implementation and maintenance of programs crafted to assure control of processes and products toward established standards of quality. The position uses problem solving techniques to increase quality and efficiency within the المزيد...

Responsibilities:Under general supervision responsible for the coordination and the preparation of documents/packages for regulatory submissions.Review and evaluate technical and scientific data and reports required for submission in support of companies products.This section contains المزيد...

Roles & Responsibilities:GMP Experience.Minimum 8 years in a GMP-regulated biopharmaceutical environment.Quality Assurance Experience .At least 2 years specifically in a QA role.QA Compliance Knowledge.Strong knowledge of QA Compliance systems including.Quality Management Review ( المزيد...

Responsibilities: Develop implement and maintain software quality assurance processes for non-product software used in medical device development.Ensure adherence to regulatory standards (FDA ISO 13485 IEC 62304) and industry best practices for non-product software.Support audits and المزيد...

Responsibilities:The Senior Manager Regulatory CMC Technical Writing and Submission Management role will be responsible for supporting the authoring compiling and management of CMC sections for global regulatory filings.This role requires a strong understanding of the drug development المزيد...

Job Description:We are seeking a Cleaning Validation Engineer with hands-on experience in the startup and validation of clean utility systems such as Water Generation Systems (WFI/RO/DI) Clean Steam Systems Process Gas/Air Systems Distribution Systems Storage Tanks and CIP/COP Systems المزيد...

Job Description:We are seeking to add top talent to our Materials Support team. The Material Handler performs operations of the Supply Chain/Materials Management department with awareness and knowledge of the various areas of the operations in Goods Receipt Goods Issue Warehousing Inv المزيد...