- Harvard University (Cambridge, MA)
- …observational studies, and as statistical project manager for IMPAACT's clinical trials involving regulatory submissions. Commitment to Equity, Diversity, ... Department Office Location:USA - MA - Boston Business Title:Biostatistician/Statistical Project Manager for Regulatory Submission StudiesSub-Unit: Appointment… more
- Merck (Boston, MA)
- …development products and non - Company marketed products. + Analyzes and anticipates project risks as they relate to clinical supply chain deliverables and ... the operational/executional arms within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and… more
- Merck (Boston, MA)
- … development teams and the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary ... with key partner organizations(as a lead GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to… more
- Sanofi Group (Waltham, MA)
- **Job title: Director Non - clinical Biostatistics - Vaccines** + Location: Swiftwater, PA or Waltham, MA (must have ability to work onsite 2-3 days per week per ... Biostatistics team in Sanofi Vaccines as the **Director of Non - clinical Biostatistics** where you will lead a...Broad knowledge and good understanding of statistical techniques and regulatory requirements in clinical assay and diagnostic… more
- Charles River Laboratories (Boston, MA)
- …passionate about. **Job Summary** We are seeking anexperienced **Director of Regulatory Services & Compliance** to join our **Insourcing Solutions** team, located ... **in Boston, MA, San Diego, CA, or San Francisco, CA.** As the **Director of Regulatory Services & Compliance** , you will lead regulatory and compliance teams,… more
- Merck (Boston, MA)
- …colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, etc.) is ... including at least 2 years of direct experience with developing and managing clinical quality systems and management of regulatory inspections. + Knowledge and… more
- Takeda Pharmaceuticals (Boston, MA)
- …and execute a clinical development plan that will result in the regulatory approval of the compound in multiple regions. Applies clinical /medical decision ... corporate goals and for Takeda to have future commercial products. **ACCOUNTABILITIES:** Clinical team leadership and Project Team / Clinical team… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …studies within a clinical development plan that will result in the regulatory approval of the compound in multiple regions. Applies clinical /medical decision ... as co-leader of these teams. + Supports the Global Project Team to ensure that the clinical ...studies and compound in conjunction with Pharmacovigilance. + Oversees non -medical clinical scientists with respect to assessment… more
- Novo Nordisk (Lexington, MA)
- …for the US East Coast Hub. Will interact with Medical Specialists, Clinical Operations, Medical writing, Regulatory , Data Science (statistics, pharmacometrics), ... 1-4 in Clinical Development program(s) + Develop clinical pharmacology strategy for project (s) and align...that impact dosage and dose setting including CMC, Device, Non -clin and clinical activities + Available and… more
- Dana-Farber Cancer Institute (Boston, MA)
- …DFCI's extensive network of in- and out-patient centers offering all phases of clinical trials, both treatment and non -treatment, to patients across DFCI and ... field required. Advanced degree (MS, MSN, MHA) preferred. + 15 years of clinical trials clinical and regulatory operations management experience required.… more
- AbbVie (Boston, MA)
- …interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other ... to augment expertise in the therapeutic area. *Responsible for understanding the regulatory requirements related to the clinical studies and global drug… more
- Regeneron Pharmaceuticals (Boston, MA)
- …functions + Contributes to overall Program strategy and interacts with Regulatory , Clinical Pharmacology, Research, Non Clinical functions, and more, to ... physician scientist with significant pharmaceutical/biotechnology sector and/or exceptional academic clinical trials' experience. With oversight from supervisor, works with… more
- Children's Hospital Boston (Boston, MA)
- …Posting Title:Process Improvement Manager, Clinical Research OperationsDepartment:Research- Clinical Research Core ... and execution of strategic and tactical process improvement initiatives for Clinical Research Operations across the hospital. The Manager will present potential… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …contribute to longer-term development strategies executed over the course of multiple non - clinical experiments, clinical studies and PMx analyses. You ... into clinical study reports + Provide CP support of regulatory documents, communications, and presentations (eg, IND, health authority queries, preparation of… more
- Commonwealth Care Alliance (Boston, MA)
- …appropriately for various audiences' Strong ability to explain technical and clinical informatics concepts to non -technical audiences. + Intermediate computer ... **Why This Role is Important to Us:** The Clinical Informaticist is a Registered Nurse, clinician or...production. This work is conducted through a mix of project management and adherence to the IT Software Delivery… more
- Beth Israel Lahey Health (Boston, MA)
- …**Time Type:** Full time **Work Shift:** Day (United States of America) **FLSA Status:** Non -Exempt **When you join the growing BILH team, you're not just taking a ... in people's lives.** The Department of Neurology at BIDMC is seeking a Clinical Research Coordinator to support a centralized clinical research program. The… more
- Cambridge Health Alliance (Somerville, MA)
- …and other feedback. Facilitates and monitors staff participation in mandatory/ regulatory in-service programs. Supports professional development/ clinical ladder ... Clinical Nurse Educator - Ambulatory Apply Refer a...including orientation. Support professional development through continuing education programs, project management and committee work Responsibilities: Coordinates ambulatory care… more
- Sanofi Group (Cambridge, MA)
- …organization. Our Medical function serves as a key strategic partner with commercial, regulatory , clinical , and market access on therapeutic solutions to support ... align goals and strategies. + The role will bring in-depth knowledge of clinical studies, ensuring that medical plans and strategies are underpinned by robust… more
- HealthEdge Software Inc (Boston, MA)
- **Overview** **Position Overview** **:** HealthEdgeis seeking a skilled Technical Project Manager to lead critical initiatives in itsInfrastructure area, including ... enables our customers to react swiftly to the latest regulatory shifts and competitive pressures. It opens the door...fuel a digital transformation, reduce costs, and improve both clinical outcomes and the member experience. **Your Impact** **:**… more
- Takeda Pharmaceuticals (Boston, MA)
- …strategic direction to cross-functional project teams to ensure that clinical regulatory documents (eg, investigators' brochures, study protocol and ... present key clinical messages in accordance with program goals and regulatory requirements. You will write and/or provide direction and leadership to other… more