R & D Jobs in Lexington, Massachusetts

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236 Lexington, MA R & D jobs found on Monster.

Jobs 1 to 20 of 236
PRIMARY ROLES: Responsible for the management of US regional regulatory activities for assigned development and commercially marketed products in the US. The major roles and responsibilities of this position are: i) Responsibility for corporate liaison with FDA and other national regulatory agencies as appropriate; ii) Responsible for the development, content and submission of complete and quality...
Primary Duties: The Regulatory Process Standards Lead will further the vision for Global Regulatory Affairs (GRA) in alignment with the One Shire business model to establish and document global process and standards. This position will collaborate with all functions within GRA to design optimum Shire Regulatory processes and interfaces between GRA and Shire functions and contribute to the directio...
Primary Duties: Responsible for the design, development, and validation (both internal and external at CROs) of a broad range of bioanalytical assays including Immunoassays (PK, ADA, and biomarker) and activity or cell-based neutralizing antibody assays to support in accordance with appropriate global regulatory guidance. Schedule activities in accordance with line function and program/corporate g...
PRIMARY ROLES: The Regulatory Technologies and Information Management Lead will further the vision for Global Regulatory Affairs (GRA) in alignment with the One Shire business model to establish and support the new/existing systems and Regulatory information management needs within GRA. This individual will collaborate with all functions within GRA and R&D IT to contribute to the direction and imp...
Primary Duties: The Submissions Portfolio Lead is a team leader with first line accountability for the quality, accuracy and timeliness of regulatory submissions for their assigned business unit(s). This role is responsible for setting the vision for assigned team and collaborating with GRO leadership to set goals, drive process efficiencies and overall operational effectiveness for regulatory sub...
Primary Duties: • Serve as clinical operations due diligence team member for assigned due diligence exercises in close partnership with GCDO internal teams to ensure alignment of costs, timings and metrics with Shire standards • Support GCDO due diligence and integration team lead in integration activities to ensure efficient knowledge transfer and efficient integration of acquired assets Responsi...
Primary Role: Responsibilities of this position include overseeing the design, development, improvement, qualification, and transfer of immunoassay methods to support studies for process development, product stability and product release. Specific focus will be the development and inventory management of associated critical reagents; this requires outsourcing antibody development/procurement and m...
Primary Role: The Senior Clinical Editor will be required to edit, format, and perform quality control (QC) checks of clinical documents intended for submission to regulatory agencies, as well as assist the Editing and Publishing Team Lead in scheduling and tracking of QC tasks, overseeing external QC vendors as necessary, and identifying, developing, refining, and disseminating QC process improve...
Synageva BioPharma Corp. JOB DESCRIPTION JOB TITLE Associate Director Purification Process Development REPORTING RELATIONSHIP This position reports to the Senior Director of Process Development DATE AVAILABLE Open LOCATION Lexington, MA RESPONSIBILITIES The Associate Director of Purification Process Development is responsible for managing a group whose mission is development of cGMP protein purifi...
Primary Duties: To deliver quality patient engagement and recruitment services that enable study teams to plan, forecast, remodel and deliver on patient enrollment goals, and work to broadly deploy innovative processes, methodologies, data, and technologies for future implementation Responsibilities: 75% Execute and deliver day to day patient engagement and recruitment service and deliverables for...
Primary Role The Global Development Team Leader ("GDTL") will be responsible for the leadership and matrix management of all aspects of 1-4 Development Programs, from the end of preclinical development stage through post-commercialization. The position will be within the Internal Medicine therapeutic area and will focus on transplant medicine. Individuals applying for this role should possess a br...
Primary Duties: • Drives clinical activities of one or more Programs including life cycle management (LCM) and co-leads the development operations team (DOT) • In collaboration with the DOT, defines clinical strategy (clinical development plan, CDP) which is aligned with the Program strategy as defined by the global development team (GDT) • Responsible for the benefit/risk clinical assessment, in...
Primary Duties: Reporting to the Clinical Documentation Team Lead, the Clinical Document Manager is responsible for overseeing Clinical Documentation Team (CDT) resource management globally, ensuring effective support for Clinical Development Operation's (CDO) document deliverables. Monitors and supports team compliance with regulatory legislation and Shire policy. Oversees effective outsourcing o...
Our client in Lexington, MA is looking for a Development Specialist II .This is a long term consulting position.If interested, Please apply to this ad Job Title: Development Specialist II Job Ref #14 -01179 Job Location: Lexington, MA, 02421 JOB DESCRIPTION: The successful candidate will join a team that supports all analytical development activities for two late-stage programs. Key responsibiliti...
Synageva BioPharma Corp. JOB DESCRIPTION JOB TITLE Purification Process Scientist/Sr. Scientist REPORTING RELATIONSHIP Director of Process Sciences DATE AVAILABLE Immediately LOCATION Lexington, MA RESPONSIBILITIES TheProcess Scientistwill be responsible for supportingdownstream process development activities. The candidate for this position will be an integral member of the Process Development te...
Synageva BioPharma Corp. JOB DESCRIPTION JOB TITLE Purification Process Scientist/Sr. Scientist REPORTING RELATIONSHIP Director of Process Sciences DATE AVAILABLE Immediately LOCATION Lexington, MA RESPONSIBILITIES TheProcess Scientistwill be responsible for supportingdownstream process development activities. The candidate for this position will be an integral member of the Process Development te...
Our client in Lexington, MA is looking for a Clinical Supply Associate. This is a long term consulting position. If interested, Please apply to this ad Position: Clinical Supply Associate Location: Lexington, MA Job#: 14-01132 Job Description: Under the direction of the Clinical Supply Manager, the Senior Clinical Supplies Specialist manages all drug products and devices; packaging, labeling, Ship...
LEXINGTON, 02420
As an Army National Guard Chemical Operations Specialist, you'll be there and prepared whenever a community is flooded, an earthquake shakes the foundations of a city, a hurricane makes landfall, or an enemy uses biological or chemical warfare. You will know what to do to evacuate the area, control the situation, and solve the problem. In order to perform these functions, you will be trained to ex...
The BA is a bridge between the Business (Need) and the Technology (Solutions). The Business need can be anything about overall business systems (model, process, method etc.) and solutions can be about efficient use of technology (architecture, tool, software application etc.). The BA is required to analyze, transform and ultimately resolve the business problems with the help of technology. The BA...
Primary Purpose: · Administration of ongoing clinical and pre-clinical studies including: maintenance of current regulatory documentation according to Regulatory Guidelines, and creation and maintenance of Trial Master File (TMF) and clinical trial site files, participation in TMF audits, management of study device accountability, ordering and tracking of study supplies, and tracking study-related...
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