Job Summary: The Manger of Regulatory Affairs is responsible for managing the regulatory and scientific aspects of projects/products including the preparation and submission of correspondence and applications to regulatory agencies (CDHR, ...
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: 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...
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: Provide programming support for study deliverables as assigned, ensuring that timelines are met and expected quality is attained. Liaise with Data Management and Biostatistics for database and dataset specifications, ti...
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...
Job Description: Our team is dedicated to discovering new targets for treating autoimmune and chronic inflammatory diseases through computational analysis of human disease tissue-derived datasets and validating these targets using in vitr...
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: 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...
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: 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 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, ...
Roles & Responsibilities: Provides real-time support for manufacturing issues on the production floor. Leads investigations into quality events using root cause analysis. Collaborates with subject matter experts to determine immediate a...
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: 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: 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: Responsible for the oversight of all data management CRO activities supporting company's clinical programs from database start-up through database lock and CSR/submission. Serves as primary point of contact with the DM ...
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: 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...