Job Description: The CSV Specialist is responsible for planning, coordinating, and executing validation activities for computer systems to ensure compliance with regulatory requirements. This role involves working closely with IT, Quality ...
Responsibilities: Review change controls for approved Abbreviated New Drug Applications (ANDAs), unapproved but submitted ANDAs, and make appropriate regulatory determination. Write, review and compile documentation and data necessary fo...
Responsibilities: Develop and maintain SAS programs to import, clean, and validate clinical trial data. Use R for data manipulation, analysis, and visualization. Perform statistical analyses in accordance with study protocols and analys...
Job Description: The Clinical Data Manager (CDM) is responsible for the oversight, integrity, and quality of clinical trial data from collection through database lock. The CDM ensures that data is accurate, consistent, and meets regulatory...
Job Description: The Regulatory Affairs Associate will be responsible for managing, authoring, and compiling Chemistry, Manufacturing, and Control (CMC) sections of regulatory submissions for marketed product variations, including Class II...
Job Description: The Senior Statistical Analyst is a key role in the research and development of new pharmaceutical products. The primary responsibilities for this role include the analysis and reporting of clinical trial data and leadin...
Job description: We are currently seeking a highly motivated and passionate scientist to join our team in Immunology Discovery based in Cambridge MA. In this role, the candidate will collaborate with multiple cross-functional teams to adva...
Responsibilities: Lead and manage CSV (Computer System Validation) for GxP systems across Quality, Manufacturing, Clinical, and Business areas. Develop and maintain validation procedures, templates, and master validation plans. Prepare ...
Responsibilities: Defines scope of quality control activities with the document author and the required source documents and data required. Conducts independent quality control review of documents per applicable checklist by checking aga...
Responsibilities: Defines scope of quality control activities with the document author and the required source documents and data required. Conducts independent quality control review of documents per applicable checklist by checking aga...