Responsibilities: Leads all DM lifecycle activities, from study start-up, maintenance, database lock and close-out. Independently develop DM documents including but not limited to Data Management Plans (DMP), Case Report Forms (CRFs), CR...
Responsibilities: Providing statistical programming support to generate tables, listings, and figures for assigned projects. Demonstrating proficiency in CDISC, SDTM, and ADaM to support various submission activities, including IA, CSR, ...
Job Description: We are seeking an experienced Compliance Specialist to support enterprise-scale vulnerability remediation, OS upgrade projects, and infrastructure compliance across lab and manufacturing environments. This role demands a s...
Responsibilities: Provide leadership, strategic planning, direction and implementation of clinical systems for data collection which may include vendor selection, budgeting, resource planning, vendor oversight, EDC build and study timelin...
Responsibilities: Author and compile CMC sections of regulatory applications, including INDs, IMPDs, CTAs, amendments, and annual reports. Documentation: Draft and maintain high-quality CMC regulatory documents such as Module 2 and 3 sum...
Responsibilities: The Senior Manager of Statistical Programming is a leadership role which manages a team of statistical programmers in the research and development of new pharmaceutical products. The Senior Manager of Statistical Progra...
Responsibilities: In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key m...
Roles & Responsibilities: Provide QA oversight of CQV activities for the cGMP manufacturing facility and quality control laboratories. Provide QA oversight for periodic review and requalification program. Perform review of CMMS records ...
Responsibilities: Provides leadership/expertise in day-to-day statistical programming in support of ongoing projects. Develops and/or validates SAS programs to generate SDTM/ADaM datasets following industry standards, regulatory requirem...
Job description: We are looking for a highly motivated scientist to join our Exploratory Biologics group in Discovery Research Immunology. The position offers a unique opportunity for a talented scientist to work in a dynamic, innovative, ...
Responsibilities: Responsible for the study-specific data management tasks from protocol review to database lock to ensure data are collected, reviewed, and delivered with high quality, on-time, and within scope. Responsible for the accu...
Responsibilities: Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plan, SAPs, etc.). Create or review and approve CDISC-compliant datasets and corresponding documentation for electroni...
Responsibilities: Candidate should be able to design and perform cellular assays including siRNA knockdown, cell proliferation and activation screening assays. Prior primary cell culture experience is required with experience in qPCR, We...
Job Description: Support a multi-phase validation project involving the reconfiguration of manufacturing Suites 5 & 6 and implementation of Client production. Responsibilities: Equipment decommissioning and clean room updates. Valid...
Job Description: We are currently seeking a highly motivated and passionate scientist in exploratory biologics to join our team in the Immunology Discovery department based in Cambridge MA. The candidate will focus on making therapeutic m...
Responsibilities: Generating and validating statistical programming deliverables (SDTM, ADAM, TFL's) in Early Development Statistics and PK/PD Modeling and Simulation spanning all therapeutic areas. Performing data manipulation, analysis...
Responsibilities: Regulatory Labelling Documentation. Support the creation and maintenance of assigned labelling projects to enable worldwide regulatory submissions. Independently prepare and maintain the Tracking Sheets for the global ...
Responsibilities: Review and ensure accurate and high-quality statistical programming deliverables from CRO. Perform generation, validation and QC/QA of SDTM, ADam and TFL output in accordance with SOPs, SOIs, and guidance documents. Cr...
Job Description: Support a multi-phase validation project involving the reconfiguration of manufacturing Suites 5 & 6 and implementation of Client production. Responsibilities include. Equipment decommissioning and clean room updates. V...
Responsibilities: The Regulatory Affairs Manager will draft and file documentation and submission materials for new and/or existing products to regulatory authorities in support of global product registrations. Regulatory Strategy Develo...