Regulatory Compliance Prepares and submits all protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval Prepares and submits regulatory documentation that may include; IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory agencies including the Food and Drug A

Regulatory Compliance Prepares and submits all protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval Prepares and submits regulatory documentation that may include; IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory agencies including the Food and Drug A

Ensure the Sponsor Investigator and study team adhere to current FDA regulations, applicable ICH/GCP guidelines, local policies and standard operating procedures, including DFCI CTO Monitoring standards and guidelines. Adhere to the protocols' Data Safety Monitoring Plans; e.g. monitoring visit type, frequency, and required critical monitoring activities by utilizing moni

The Senior Medical Science Liaison (Sr MSL) will serve as a scientific liaison to the medical/academic community and is responsible for establishing and maintaining relationships with Health Care Providers/Professionals (HCPs) to ensure the appropriate dissemination of clinical and scientific information regarding Vertex' compounds in a timely, ethical and stakeholder foc

Vertex seeks a talented scientist to join the Vertex Cell and Genetic Therapies (VCGT) Cell therapy and Immunology team at The Jeffrey Leiden Center for Cell and Genetic Therapies in Boston, MA. The team's mission is to discover and actualize the next generation of cell therapies for patients with type 1 diabetes, sickle cell disease and Duchenne muscular dystrophy. We ar

General Summary of Position One post doctoral research associate position is available in the Department of Mechanical and Industrial Engineering at the University of Massachusetts Lowell. The position is under the direct supervision of Dr. Alessandro Sabato (Alessandro_Sabato@uml.edu). The successful applicant will conduct analytical and experimental research in the area

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The QC Specialist II Laboratory Information Systems will use th

Site Name Seattle Sixth Ave, Cambridge 300 Technology Square Posted Date May 16 2024 At GSK we see a world in which advanced applications of artificial intelligence and machine learning (AI/ML) will allow us to develop new medicines and vaccines with greater speed and efficacy. GSK is a unique company with world leading pharmaceutical and vaccines research and development

t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose to unite science, technology and talent to get ahead of disease together so we can positively impact the health of billions of people and deliver stronger

Overview The Allen Discovery Center is dedicated to the advancement of basic biology and biomedicine, and to using an integrated approach to control biological structure and function. Through a combination of molecular genetics, biophysics, and computational approaches, researchers at the Center work toward a multi level control of patterning. Novel technology is being de

Support the execution of experiments and the daily operation of the R&D lab. Perform routine laboratory activities based on established procedures. Help maintain lab equipment and analytical devices. Key Accountabilities Supports R&D projects through execution of routine lab activities based on established procedures. Performs general lab support activities, including cle

RESEARCH SUPPORT ASSOCIATE , Koch Institute for Integrative Cancer Research Anderson Lab , to support an exciting team interested in nucleic acid mediated in vivo and ex vivo immune cell engineering using nucleic acids and CRISPR/Cas9. Will provide basic technical support under direct supervision by assisting in experimental studies in cultured cells and small rodents aim

Vertex pharmaceuticals is seeking a research scientist to join the analytical development, cell and gene therapy team. This position is expected to serve as a key contributor in expanding our mass spectrometry characterization capabilities in proteomics for supporting cell and gene therapy program development. Extensive hands on experience in liquid chromatography mass sp

Collaborate with Clinical Trial Manager(s) to assist in the operational and logistical aspects of clinical trial management tasks (e.g. start up, maintenance, and close out activities) according to ICH GCP and standard operating procedures. Liaise with CROs and other clinical vendors to ensure deliverables are met and communication is efficient. Partner with Investigators

We are seeking a highly qualified and motivated Bioinformaticist or computational biologist to join our collaborative teams in the Ocular Genomics Institute and the Department of Ophthalmology at Massachusetts Eye and Ear (MEE), Harvard Medical School, to work on innovative projects that combine human genetics and functional genomics to uncover novel causal mechanisms for