Biopharma Exception Report Investigation Author

**Company Description** The Sr Specialist Quality Systems is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, combination products and biologics. Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training and CAPA....

Come grow with us! Lemieux & Associates, a national leader in the investigative industry, is seeking experienced surveillance Investigators in the Worcester, MA or surrounding area. This is a full-time position. The owners are entrepreneurial, experienced field investigators, each with over 25 years of experience. We understand the job and never forgot our...

Job DescriptionJob DescriptionCome grow with us! Lemieux & Associates, a national leader in the investigative industry, is seeking experienced surveillance Investigators in the Worcester, MA or surrounding area. This is a part-time position to start with the ability to turn into a full-time position for the right individual. The owners are entrepreneurial,...

Job DescriptionJob DescriptionCome grow with us! Lemieux & Associates, a national leader in the investigative industry, is seeking experienced surveillance Investigators in the Worcester, MA or surrounding area. This is a full-time position. The owners are entrepreneurial, experienced field investigators, each with over 25 years of experience. We understand...

Job Description Purpose: Independently performs routine and non-routine testing. Performs laboratory testing within a GMP environment in support of one or more of the following areas: raw materials, in-process product, final Bulk product, stability, and/or validation. Analyzes test data, evaluates results, and forms conclusions with minimal outside input....

Overview: GENERAL SUMMARY OF POSITION: Under the general supervision of the Department Administrator or designee, the Financial Assistant IV is responsible for the preparation of fiscal reports related to grant and contract proposal budgets and the processing and review of all grant, contract and school fund expenditures.  The position provides personnel...

Overview: GENERAL SUMMARY OF POSITION:  Under the direction of the Principal Investigator or designee, the Research Nurse Coordinator II is responsible to carry out all delegated tasks related to complex protocols testing investigational drugs, devices, or research interventions. The Research Nurse Coordinator II is a primary resource for study protocol...

Overview: GENERAL SUMMARY OF POSITION: Under the direction of the Principal Investigator or designee, the Research Coordinator I is responsible for carrying out multiple complex research protocols.     Responsibilities: MAJOR RESPONSIBILITIES: Collaborate with investigators in the design, development, and documentation of data forms, questionnaires,...

Overview: POSITION SUMMARY:  Under the direction of the Principal Investigator or designee, the Research Nurse Coordinator is responsible to carry out all delegated tasks related to complex protocols testing investigational drugs, devices, or research interventions. The Research Nurse Coordinator is a primary resource for study protocol conduct acting as...

Overview: GENERAL SUMMARY OF POSITION:  Under the general direction of the Principal Investigator or designee, the Research Program Manager I is responsible for managing the day-to-day operations of NIH or other externally funded, large scale projects. The Research Program Manager will collaborate with investigators, consultants, project directors, and...

Job Description About This Role This position supports our Research & Development organization. Individual will own the accounting for Phase 2/3 clinical trials. Candidate will partner with Clinical Financial Planners (CFPs), study teams and External Vendors to understand clinical trial contractual terms, incurred activities and Biogen obligations, with...

Overview: POSITION SUMMARY:   Under the guidance of the Principal Investigator (PI) or their appointed delegate, the role of Clinical Research Coordinator entails the independent execution of tasks and procedures associated with human subject research. This responsibility encompasses the coordination of regulatory components management and compilation of...

Overview: POSITION SUMMARY: Under the direction of the Principal Investigator (PI) or designee, the Clinical Research Coordinator is responsible for independently performing delegated tasks and procedures involving human subject research. This work includes coordination of regulatory activities and aspects of collection and management of data for research...

Overview: POSITION SUMMARY:  Under the direction of the Director or designee, the Regulatory and Compliance Specialist I is responsible for ensuring research regulatory affairs and compliance with federal and state regulations and institutional policies and procedures. Responsibilities: ESSENTIAL DUTIES: Gather data, review, and triage the submissions...

Overview: POSITION SUMMARY: Under the general direction of the Principal Investigator (PI) or designee, the Clinical Research Coordinator III is responsible for independently performing delegated tasks and procedures involving human subject research. This work includes coordination of regulatory activities and aspects of collection and management of data...

Overview: POSITION SUMMARY: Under the direction of the Principal Investigator (PI) or designee, the Clinical Research Coordinator I is responsible for independently performing delegated tasks and procedures involving human subject research. This work includes coordination of regulatory activities and aspects of collection and management of data for research...

Overview: POSITION SUMMARY:  Under the general supervision of the Manager/Department Head or designee, the Administrative Assistant I performs diversified and complex administrative duties.        Responsibilities: ESSENTIAL FUNCTIONS:   Prepare and/or update correspondence, memoranda, agendas, handouts, website updates, and reports,...

Overview: POSITION SUMMARY:  Under the general supervision of the Manager/Department Head or designee, the Administrative Assistant performs diversified and complex administrative duties.   This is an open-rank posting (there are 3 levels of Admin Assistant) - candidates will be hired into the level commensurate with their...

Overview: POSITION SUMMARY: Under the direction of the Principal Investigator (PI) or designee, the Clinical Research Coordinator II is responsible for independently performing delegated tasks and procedures involving human subject research. This work includes coordination of regulatory activities and aspects of collection and management of data for complex...

Overview: GENERAL SUMMARY OF POSITION:  Under the general direction of the Principal Investigator or designee, the Research Program Manager II manages the day-to-day operations of short term and multi-year research projects. The Research Program Manager II is responsible for the implementation of research projects from inception to completion and manages...