- Actalent (North Billerica, MA)
- …role of the Technical Writer involves supporting the team with specific quality events and revising, editing, and creating Standard Operating Procedures (SOPs) and ... work instructions. The position requires creating quality documents to ensure they adhere to all internal and regulatory standards, participating in cross-functional… more
- Actalent (Framingham, MA)
- …and manage complex investigations related to deviations, non-conformances, and quality events across manufacturing, packaging, and laboratory operations. Perform ... root cause analyses and collaborate cross-functionally with Technical Operations, Manufacturing, Quality Control, and Regulatory Affairs to gather data and ensure… more
- System One (Burlington, MA)
- Job Title: PRN Principal Investigator - Neurologist Schedule: Part-time Location: Burlington, MA Type: Contract (PRN, ~15 hours/month; open-ended assignment) ... Board-Certified Neurologist (MD/DO) to serve as a PRN Principal Investigator (PI) for a clinical research site. This is...get work done more efficiently and economically, without compromising quality . System One not only serves as a valued… more
- Takeda Pharmaceuticals (Boston, MA)
- …job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION:** Research Investigator Analytical Development **POSITION DESCRIPTION** : Takeda Development Center ... Americas, Inc. is seeking a Research Investigator Analytical Development with the following duties: Independently design, plan and execute studies on new development… more
- Citizens (Medford, MA)
- Description The Investigator II within our Corporate Security division will support the ongoing success of the Investigations function by providing an independent ... telephone guidance to business line stakeholders and customers + Drafting quality investigations reporting as appropriate - summarizing the investigation, details,… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Investigator , Ethics and Business Integrity, North America **Location:** Cambridge, MA **About the Job** Ready to push the limits of what's possible? ... family, with a wide range of health and wellbeing benefits including high- quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral… more
- State of Massachusetts (Boston, MA)
- …is to prevent illness, injury, and premature death, to assure access to high quality public health and health care services, and to promote wellness and health ... **Job:** **Compliance and Certification* **Organization:** **Department of Public Health* **Title:** *Nursing Investigator * **Location:** *Massachusetts-Boston-250 Washington Street* **Requisition ID:**… more
- Humana (Boston, MA)
- …need, when they need it. These efforts are leading to a better quality of life for people with Medicare, Medicaid, families, individuals, military service personnel, ... and communities at large. **Equal Opportunity Employer** It is the policy of Humana not to discriminate against any employee or applicant for employment because of race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital… more
- Beth Israel Lahey Health (Boston, MA)
- …regarding the protocols or consent forms. Working with the principal investigator and/or research nurse, submits protocols, amendments, notices, suspensions and ... medical record. Verifies information with clinical research nurse and/or principal investigator . May enroll patients onto clinical trials. (essential) + Monitors the… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …Summary** We are seeking an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will be responsible for leading a ... global team focused on R&D Quality . This global role includes direct reports in the...clinical facility and system audits at all relevant facilities, investigator sites, and vendors (including contract research organizations) and… more
- Dana-Farber Cancer Institute (Boston, MA)
- …other Harvard Medical School-affiliated hospitals. Administrative: + Assists principal investigator with protocol development. + Assists principal investigator ... appropriate with the Institute's protocol review process. + Assists the principal investigator in developing the protocol budget. + Collaborates with the Dana-Farber… more
- Beth Israel Lahey Health (Boston, MA)
- …coordinate clinical research protocols, as directed by the Program Manager or Principal Investigator (PI). The CRC will also have the opportunity to learn certain ... patient assessments such as collection of electrocardiograms. There may be regulatory and quality exposure in this position. The position typical hours will be from… more
- Merck (Boston, MA)
- …Adherence to GCP, local and global policies and procedures to conduct high- quality , inspection ready studies is essential. The position is accountable for trial ... quality and audit responses and completion of CAPAs. The...+ Leads strategic development and management of institutional & investigator relationships in conjunction with Research and Development/ GCD… more
- Bausch + Lomb (Boston, MA)
- …(eg, R&D/Project Management, Clinical/Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, Pharmacovigilance/GPSS and Drug/Device Safety, and Clinical ... and changes in scope, schedule, and resources. + Organize investigator and expert meetings relevant to the indication and...ICH, GCP and B&L SOPs. + Responsible for the quality of all study-related documentation (eg, Trial Master File,… more
- Dana-Farber Cancer Institute (Boston, MA)
- …trials using Good Clinical Practice under the auspices of the Principal Investigator and the Clinical Trials Office. The Clinical Research Manager, in collaboration ... Human Research Studies (OHRS), and the Office of Data Quality (ODQ) to fulfill local and federal requirements governing...their resolution. + The CRM will assist the principal investigator in developing the protocol budget, in collaboration with… more
- Sumitomo Pharma (Boston, MA)
- …Forms (ICF), Safety Management Plans (SMP), Clinical Study Reports (CSR), Investigator 's Brochures (IB), Investigator communications (Dear Health Care Provider ... (SmPC), and Canadian Product Monograph (PM) + Ensures timely and quality review and assessment of ICSRs, including seriousness, expectedness, safety narratives,… more
- Organon & Co. (Boston, MA)
- …oversight thereof while ensuring the scientific and data integrity, rigor and quality thereof. The director may represent the Clinical Pharmacology function in asset ... 2.5 and labeling for regulatory submissions, contribute the authoring of Investigator Brochures, IND subsections, briefing books, submission modules, responses to… more
- AbbVie (Worcester, MA)
- …research into novel immunology therapies for patients. Responsibilities: + Principal Investigator Leadership: Act as a principal investigator , spearheading ... patent applications, while maintaining high standards of data integrity and quality . + External Scientific Representation: Publish research findings in peer-reviewed… more
- Children's Hospital Boston (Boston, MA)
- …oversee day-to-day coordination and overall management of Industry Sponsored and Investigator -initiated clinical trials, and quality improvement (QI) initiatives ... resource development and goal setting. * Consult on and support division-wide quality improvement initiatives. Educate involved staff and advise on methods, and… more
- Charles River Laboratories (Shrewsbury, MA)
- …these projects, as appropriate. Additional responsibilities include serving as a Principal Investigator for the development and validation of biomarker, PK and ADA ... AND RESPONSIBILITIES:** * Function independently as a Project Scientist, Principal Investigator , Contributing Scientist in the direction and execution of assigned… more