Clinical Research QA & Regulatory Lead (Hybrid)
Mass General Brigham
Mass General Brigham seeks a Regulatory Coordinator to manage QA and regulatory activities for NCRI, focusing on GCP compliance, audits, and site procedures. You will draft SOPs, conduct internal reviews, and coordinate with investigators and sites to ensure adherence to regulations. The role requires 3+ years in clinical research or QA, a scientific degree, and strong leadership and communication skills. Hybrid onsite/remote work is available at MGH facilities. #J-18808-Ljbffr Mass General Brigham
- Mass General Brigham's Neurological Clinical Research Institute seeks a Regulatory Coordinator to manage QA activities, SOP development, and regulatory compliance across... ...audits and inspections. The role involves hybrid work with 2 onsite days weekly at Mass General...Regulatory
- ...Institute, Inc. in Boston is seeking a Clinical Research Manager to lead the Breast Oncology clinical... ...ensure GCP compliance, and coordinate regulatory and data management activities across... ...and evaluate trial activities, with a hybrid work arrangement in Boston. #J-1880...Regulatory
- ...Cancer Institute in Boston, MA, offers a hybrid work arrangement with 2-3 days onsite/remote per week. The Assistant Clinical Research Manager will support the Center for Early... ...Cancers in clinical trial operations and regulatory compliance under the PI and CRM supervision...RegulatoryRemote work2 days per week3 days per week
- ...Inc. in Somerville, MA is hiring a Senior Manager of QA Compliance to lead vendor qualification, supplier oversight, and GxP... ...inspection readiness while collaborating with Legal, Regulatory, and Operations. This hybrid role requires 8-10 years' QA leadership and a life sciences...Regulatory
- Boston Children's Hospital seeks a Clinical Research Assistant to join the Neurofibromatosis Clinical... ...in Neurology. The role focuses on regulatory management and active patient recruitment... ...in Brookline, MA with potential hybrid work options. #J-18808-Ljbffr Boston Children...RegulatoryRemote job
- ...Farber Cancer Institute in Brookline, MA seeks a Regulatory Coordinator II to manage regulatory requirements for clinical research projects under the Clinical Trials Office.... .../DF/HCC policies and federal regulations. Hybrid work with 2-3 days remote/onsite; collaboration...RegulatoryWork at officeRemote work
- KPS Life is seeking a Sr. Clinical Study Lead to drive global trials from planning through closeout... ..., while ensuring data quality and regulatory compliance. The role requires expertise... ...complex studies across regions, with a hybrid work model in Cambridge, MA; Armonk,...Regulatory
$71k - $96k
Hmixray is seeking a Senior Clinical Studies Associate to support planning and execution... ...involves project management, documentation and regulatory compliance, ensuring quality standards... ...minimum of 2 years of related clinical research experience. Responsibilities include...RegulatoryRemote job- ...a Director of Gift Annuity Compliance to lead a three-person team and own the annual filings... ...and set the standard for accuracy in regulatory compliance for charitable gift annuities.... ...compliance, and a track record of hybrid team leadership. #J-18808-Ljbffr Giving...Regulatory
- ...is seeking a Senior Manager, Clinical Trial Delivery and Pharmacovigilance... ...Documentation Excellence in a hybrid role in Cambridge, MA. You... ...Delivery, Medical, PV, and QA to maintain high-quality records... ...requires strong TMF/eTMF expertise, regulatory knowledge, and program...Regulatory
- AstraZeneca plc in the United States seeks an Associate Director, Regulatory Affairs, CMC - CGT to lead the regulatory strategy for our Cell & Gene Therapies portfolio. This hybrid role may be based in Santa Monica, CA, Gaithersburg, MD or Boston, MA, and reports to the...Regulatory
- Takeda is seeking an Associate Director of Global Regulatory Strategy in Cambridge, MA for a hybrid, full-time role. You will lead global regulatory strategies across complex programs and serve as the primary interface with health authorities, including FDA meetings. The...RegulatoryFull time
- KPS Life is hiring a Clinical Study Specialist to support sponsor partner trials through... ...ideal candidate has 2+ years of clinical research experience and strong organizational and... ...CSS will assist with TMF reconciliations, regulatory binders, study manuals, and data...RegulatoryWork at office3 days per week
- ...General Brigham seeks a detail-oriented Clinical Trials Assistant/Project Manager to... ...multiple trial sites, ensure regulatory documents are complete, and guide site... ...handling, and collaboration with QA and department managers. Hybrid work arrangement with on-site requirements...RegulatoryRemote job
- Alva Energy, Inc. seeks a Quality Assurance Program Lead to stand up and run a comprehensive QA program for a first‑of‑a‑kind energy project. You will... ...perform audits, and manage corrective actions to ensure regulatory compliance and safety‑critical quality. You will...Regulatory
- ...MA is seeking a Translational Research Project Manager I to coordinate... ...grant applications, regulatory compliance, and data collection. The role bridges clinical and laboratory research, supervises... ...of investigator-led projects. Hybrid work includes 2-3 days onsite...RegulatoryRemote work
- Mass General Brigham is seeking a Quality Assurance Manager for the Neurological Clinical Research Institute (NCRI) at 399 Revolution Drive, Boston. This role directs QA activities across clinical studies, ensuring adherence to GCP, regulations, and the NCRI Quality Management...Regulatory
$227.9k - $308.3k
...Pharmacovigilance Quality Assurance Lead provides executive... ...direction for the GVP QA function and provides... ..., and long-term regulatory compliance.This role can... ...Philadelphia, PA in a hybrid work arrangement, or remotely... ..., Quality, Regulatory, Clinical, Commercial, and...RegulatoryFull timeTemporary workLocal areaRemote workFlexible hours$150k - $180k
Title: Quality Assurance Program Lead Location: Boston (Hybrid) with travel to project or vendor sites as required Help build the quality program that... ..., Procurement, and Project Management Develop the QA Program Manual and user-focused procedures aligned with NQA...For contractors$79.4k - $91.9k
The Translational Research Project Manager I (TRPM I)... ...biological samples and clinical data. This role... ..., project initiation, regulatory compliance, and patient... ...position’s work location is hybrid with 2-3 days onsite... ...Collaborative Meetings: Lead and participate in...RegulatoryRemote work- Yoh is seeking a Senior Specialist in Clinical Supply Chain Operations in Massachusetts... ...site readiness. You’ll collaborate with QA, Regulatory, and external vendors to maintain... ...and visibility. Responsibilities include leading end-to-end supply activities, monitoring...Regulatory
- ...World Evidence Expert to independently design, lead, and deliver global evidence studies. The role targets informing regulatory and payer interactions and advancing disease-... ...across US and non-US teams in a hybrid setup. The role emphasizes asset-level evidence...Regulatory
$120.2k - $180.4k
...preparing moderately complex clinical and regulatory documents and represents... ...functional stakeholdersServes as the lead Medical Writing Scientist... ...drug development, clinical research, study designs,... ...much more.Flex Designation:Hybrid-Eligible Or On-Site EligibleFlex...RegulatoryFull timeSummer workRemote workFlexible hours2 days per week- ...staff on respirator use and maintenance, and keeps precise records for regulatory compliance. The position emphasizes safety culture and adherence to OSHA standards. The incumbent will work a hybrid schedule at our Somerville area facility, with local travel as needed,...RegulatoryLocal area
$220k - $240k
...MA is seeking a Director of Patient Marketing for Duvyzat to lead the patient marketing strategy, engage patients, caregivers and families, and drive adoption while ensuring regulatory compliance. This hybrid role requires 7+ years in marketing (rare disease preferred),...Regulatory- Climb Bio, Inc. is seeking a Senior Clinical Trial Manager to lead end-to-end delivery of Phase 1-3 studies... ..., strong knowledge of GCP and regulatory requirements, and excellent communication... .... This position offers a remote or hybrid model based out of Wellesley, MA,...RegulatoryRemote job
- ...Cambridge, MA seeks a Senior Manager to provide scientific and clinical oversight of clinical trials in the Inflammation & Immunology... ...with collaboration across Clinical Operations, Biostatistics, Regulatory Affairs, and Clinical Pharmacology. The incumbent will leverage...Regulatory
- Massachusetts General Hospital, part of Mass General Brigham, seeks an experienced Regulatory Affairs Coordinator to lead regulatory risk management for a nationwide Alzheimer's platform trial. You will collaborate with IRBs, regulatory agencies, investigators, and study...RegulatoryLocal area
- Glaukos Corporation in Acton, MA, is seeking a Sr. Regulatory Affairs Specialist to lead the preparation of regulatory submissions for the U.S. and international markets. The role is hybrid and full-time, requiring a proactive regulatory mindset and collaboration with...RegulatoryFull time
$63.25k - $102.6k
...people, tech experts, researchers, and systems... ...of a large global clinical study. This position... ...agencies and other regulatory bodies. Collecting... ...Assurance (QA) and Regulatory Affairs... ...vendors. Ability to lead and mentor cross-... ...of QA. Remote Type Hybrid Work Location 399...RegulatoryWork experience placementWork at officeRemote workShift work
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