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

No direct supervision of others, but does supervise assistive personnel as appropriate in the provision of patient care Qualifications Licensed as a registered Nurse in the Commonwealth of Massachusetts, or New Hampshire as appropriate Baccalaureate degree in nursing strongly preferred. If associate degree in nursing, must complete BSN degree within 4 years Minimum of 1 y

In collaboration with a physician, the NP/PA manages therapeutic regimens for acute and chronic problems associated with such disease, treatment and/or conditions. The NP/PA provides anticipatory guidance, patient and family education, and psychological and emotional support. The NP/PA has prescriptive authority which includes schedule II through V controlled substances i

In collaboration with a physician, the NP/PA manages therapeutic regimens for acute and chronic problems associated with such disease, treatment and/or conditions. The NP/PA provides anticipatory guidance, patient and family education, and psychological and emotional support. The NP/PA has prescriptive authority which includes schedule II through V controlled substances i

1 direct report with contract staff as needed. Qualifications Bachelor's degree; degree in communications or marketing preferred. 10 years of communications experience; preferably within Human Resources communications in healthcare, academic or corporate organizations 5 years of senior level management experience Experience as a senior communications professional and an e

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

Oversight of the clinical trials start up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities. Responsible for data reporting and management, collection of source documents, use and development of case report forms, adverse events reporting, filing and archiving of study records, and resolution of d

Oversight of the clinical trials start up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities. Responsible for data reporting and management, collection of source documents, use and development of case report forms, adverse events reporting, filing and archiving of study records, and resolution of d

The Animal Technologist reports directly to the Animal Resources Facility (ARF) Technical Services Manager or Technologist Supervisor. The Animal Technologist provides animal clinical care and treatment to research animals as prescribed by the ARF Technical Services (TS) Manager/Supervisor and as directed by the Attending Veterinarian. Under the direction of the TS Manage

The Manager of FP&A is a key member of Vertex's Finance business partner organization, supporting the Global Clinical Operations (GCO) function by providing financial direction and insight including identification of key value drivers and Business KPIs, helping GCO deliver their short term and long term goals through proactive day to day support, challenge, influence and

Support select branded and unbranded tactics for the Institutional & IDN channel, including strategic engagements, channel convention support, team meeting & training support, market research, and advisory board formation Lead the IDN and institution strategic council Develop and execute branded 548 assets that effectively position the brand in the institution; this inclu

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

This Scientist will support Vertex's drug development programs by applying conceptual knowledge to understand various relationships between fundamental materials properties, pharmaceutical processing conditions, and final product performance and quality attributes. The role will have a proven track record of applying conceptual knowledge of materials science and engineeri