- Sanofi Group (Cambridge, MA)
- …support from "target identification" to "compounds in development" by providing appropriate non clinical statistical support for efficacy and safety internal or ... the limits of what you thought was possible. Ready to get started? The Non - Clinical Efficacy and Safety (NCES) team, within the Global Biostatistics and… 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
- Sanofi Group (Cambridge, MA)
- …strategy to ensure preparation timelines meet the project timelines for clinical trial initiation + Ensure that regulatory messaging for regulatory ... internal business partners, including but not limited to the clinical development teams, commercial and Global Regulatory ...as appropriate + Contributes to the development of Global Regulatory Project Strategy (GRPS) and ensures alignment… 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
- Orchard Therapeutics (Boston, MA)
- …such as CLIA and EU IVDR, and execution feasibility. . Partner with Clinical Science and Regulatory Science teams to provide subject matter expertise ... of clinical study protocols and reports. . Exposure to regulatory agency inspection. . Career progression reflects successful performance. Skills & Abilities… 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
- 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
- Pfizer (Cambridge, MA)
- …Area. Your project management skills will be leveraged to develop clinical trial timelines and oversee budgets for the assigned clinical studies/programs. ... or business required + 10+ years of relevant experience (prior clinical trial, non -interventional study and/or epidemiologic study) **Prior Experience:**… 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
- Pfizer (Cambridge, MA)
- …and ensures quality database design including documentation, testing and implementation of clinical data collection tools, both CRF and non -CRF, using an ... and determine study requirement from protocol review + Strong Project and Risk Management + CRO and vendor oversight... research, FDA & ICH, GCP, GCDMP, and related regulatory requirements + Proficient experience using commercial clinical… more
- Sanofi Group (Cambridge, MA)
- …within our Finance team you'll manage the financial aspects of a strategic clinical development project aimed at improving the lives of millions. Overseeing ... **Main Responsibilities:** + Manage the financial aspects of a strategic clinical development project , including budgeting, forecasting, and tracking actuals… more
- Atrius Health (Newton, MA)
- …. Responds to ad-hoc data requests, including data requirements in response to regulatory agency requests. . Teams with Sr. Clinical Operations Leadership to ... so that we can serve them well. Across 32 clinical locations, more than 50 specialties and 825 physicians,...initiatives to assess financial and operational viability. Serves as project leader for complex data analysis projects that can… more
- Regeneron Pharmaceuticals (Boston, MA)
- …Quantitative Pharmacology, Preclinical PK-PD, Toxicology, Bioanalytical, Therapeutic Focus Areas and Clinical Development / Regulatory Affairs. We expect the ... We are looking for a Senior Clinical Pharmacologist. This individual will plan, design, implement...the scientific understanding of human PK/PD for the assigned project (s), based on quantitative evaluations of the pharmacokinetic and… more
- Regeneron Pharmaceuticals (Boston, 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
- 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
- Randstad US (Norwood, MA)
- …environment. This role will report to the Associate Director, Laboratory Compliance, Clinical Biomarker Laboratory. This is a non -remote position. + Execute ... to meet project timelines and business needs while adhering to regulatory requirements. + Ensure Standard Operating Procedures (SOPs) and procedures are created,… more
- WTW (Boston, MA)
- …and pharmacy documentation illustrating compliance with MHPAEA + Coordinate with Project Manager regarding sending requests, timing, status, and follow-up + Attend ... of response and report any issues or impact to timeline proactively to Project Manager + Complete initial review of carrier responses for parity projects +… more
- Harvard University (Cambridge, MA)
- …Science Council clinical experts, funders, institutional review boards (IRBs), and project governance boards in the US, and globally (primarily India) Research + ... Department Office Location:USA - MA - Boston Business Title:Senior Project ManagerSub-Unit: Salary Grade (https://hr.harvard.edu/salary-ranges#ranges) :057Time Status:Full-time Union:00 -… more
- Fresenius Medical Center (Waltham, MA)
- **POSITION FEATURES:** **Must have Clinical ( Non IT) Project Manager Experience** **CAPM/PMP Certification a Must Have** **PURPOSE AND SCOPE:** Are you a ... passionate expert of continuous process improvement ** Project Manager** looking to grow your career and make... work for high reliable processes and excellence in clinical and business outcomes. **PRINCIPAL DUTIES AND RESPONSIBILITIES:** +… more