- Alkermes (Waltham, MA)
- …all sources, compliant case processing and reporting, medical review, signal detection, risk management programs and safety related labeling Schedule, personally ... Global Head of CQA and the CQA GLP and GCP organization regarding quality oversight of safety.../GPvP audit activity, develop and present periodic metrics and risk management to company leadership When requested… more
- AstraZeneca (Boston, MA)
- …scientific aspects of the cell therapies in Neuroinflammatory indications, including the benefit/ risk of a product and/or asset as well as the scientific strategies ... design and delivery of clinical development plans with high quality and speed Essential Skills/Experience: An MD, or other...decisions. Thorough command of FDA, EMA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of global… more
- Akebia Therapeutics (Cambridge, MA)
- …programs, ensuring the timely completion of deliverables through the development and management of the project timelines and budgets. In conjunction with the Senior ... effectively manage interactions between functional groups such as monitoring, data management , biostatistics, medical writing, safety, regulatory affairs and QA. The… more
- Mythic Therapeutics (Waltham, MA)
- …Directs the team and/or participates in study data review and assists with site management to ensure data quality and timely data entry Build and maintain ... of Global clinical studies in accordance with timeline, budget and compliance/data quality goals. The Associate Director will be responsible for evaluating and… more
- BioPharma Consulting JAD Group (Cambridge, MA)
- The Senior Manager, Global Pharmacovigilance (PV) Quality Assurance is a key member of the GVP QA team, providing global quality oversight of post-marketing ... GVP audit program and inspection readiness initiatives. Key Responsibilities: Provide quality oversight of global pharmacovigilance (PV) systems and ensure alignment… more
- Kymera Therapeutics (Watertown, MA)
- …their performance and ensuring adherence to contractual agreements, timelines and quality standards Ensure compliance with regulatory requirements, ICH- GCP ... a key immunology program in accordance with project timelines, budget, and quality standards Develop and manage comprehensive program project plans, including but… more
- Presidio (Woburn, MA)
- …Manager, Digital Sales provides support for the acquisition of new customers and management and growth of existing customers. You are expected to achieve quarterly ... services associated with: Public Cloud (AWS is preferred but Azure and GCP are also supported) DevOps Application Development Data & Analytics Demonstrated ability… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management and Statistics, with at least 3 years of experience in GCP Quality /Compliance. + Advanced knowledge of pharmaceutical development, medical affairs ... focuses on defining activities, processes, and standards to meet quality requirements relevant to deviation management and...Clinical Pharmacovigilance and Medical Quality and R&D Quality leadership for proactive risk mitigation and… more
- Santander US (Quincy, MA)
- …at all levels are expected to take a proactive and responsible approach toward risk management . **EEO Statement:** At Santander, we value and respect differences ... to other team members. + Good knowledge of data quality & data management platforms (Informatica is...Hands-on experience with cloud platforms (eg, AWS, Azure, or GCP ) including services such as Lambda, S3, Azure Functions,… more
- ICON Clinical Research (Boston, MA)
- …of clinical studies, in compliance to all applicable regulations (like ISO, GCP and FDA) and Philips procedures, working under limited supervision. + Ensures ... as a subject matter expert to provide guidance on GCP , ISO and FDA regulatory requirements for the conduct...study procedures and processes to optimize efficiency and data quality throughout the clinical research lifecycle and performs data… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management and Statistics, with at least 3 years of experience in GCP Quality /Compliance. + Advanced knowledge of pharmaceutical development, medical affairs ... risk register are evaluated and escalated to the Quality council and RDQ LT as applicable + Drive...projects. + Successful management of business transformation/change management initiatives eg quality system integration, outsourcing… more
- Takeda Pharmaceuticals (Boston, MA)
- …Strategy Review; focus on ensuring accurate assumptions are applied and robust risk management plans are in place. + Provide oversight/support/guidance to ... Oversee the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP , local regulations and Takeda SOPs), on… more
- Takeda Pharmaceuticals (Boston, MA)
- …and TA leadership to define operational strategy for clinical programs, including risk management and contingency planning for clinical programs and clinical ... or other continuous improvement to achieve cost-reduction, time-savings, efficiency, quality and/or other business objectives. This individual will also be… more
- ICON Clinical Research (Boston, MA)
- …preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study ... to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of risk based monitoring approaches at the site level and to work with site… more
- Dana-Farber Cancer Institute (Boston, MA)
- …position is responsible for data logistics activities involved in the electronic management , retrieval, and transmittal of imaging data sets. The Image Data ... position includes the data retrieval and transmission from electronic software applications, quality control, acting as the escalation point for issues presented by… more
- Orchard Therapeutics (Boston, MA)
- …analyses (PBRERs / DSURs), regulatory submissions (BLA/NDA/MAA dossiers, briefing documents, Risk Management Plans, REMS), and post-marketing commitments. + ... Creating detailed reports and evaluations of benefit- risk for internal audiences and external regulatory stakeholders. + Driving proactive, continuous risk … more
- Blue Cross Blue Shield of Massachusetts (Boston, MA)
- …teams, fostering a culture of innovation and continuous learning in GenAI. + Risk Management & Compliance: Identify and mitigate risks associated with GenAI ... (eg, PyTorch, TensorFlow, Hugging Face, LangChain), and cloud services (AWS, Azure, GCP ) based on specific healthcare use cases and organizational standards. +… more
- Deloitte (Boston, MA)
- …cyber programs in line with a client's strategic objectives, regulatory requirements, and risk appetite. It keeps the enterprise a step ahead of the evolving threat ... organization's cyber posture. Includes design of the cyber organization, governance, and risk assessments. The recruiting for the role ends on 8/31/2025 Work You'll… more
- Cisco (Boston, MA)
- …container security, Kubernetes, and microservices architectures + Experience in security risk management , vulnerability assessment, and remediation + Experience ... and networks. Lead design, influence and contribute to implementation to deliver quality and timely release. Collaborate with multiple teams, including Product and… more
- Deloitte (Boston, MA)
- …of Deloitte Tax LLP in a variety of ways, including: + Client Management : Manage the day-to-day interactions with executive clients and sponsors. + Delivery: Manage ... model evaluation, roadmap development for a desired future state, data management solutions, automation opportunities, tax portal, cloud for enterprise systems,… more
