- Sanofi Group (Cambridge, MA)
- …treatment to patients with specific illnesses where treatment access is limited. **Global Senior Manager - Governance & Risk Management** sits within Specialty ... therapies and when they are not eligible to participate in a clinical trial. Cross-GBU Pre-Registration Import License (PRIL) is designed to oversee temporary… more
- Medtronic (Mansfield, MA)
- Senior Clinical Research Business Process Improvement...who, how, duration and effort). + Partner with the clinical study teams to identify risk in ... Manager In this exciting role as Senior Clinical Research Manager in the Surgical...for the regulatory affairs function as it applies to product approval. + Studies must be scientifically valid, meet… more
- Merck (Boston, MA)
- …serves as the GCS spokesperson at clinical development related meetings (ie, Clinical Trial Teams) and product development related meetings. The incumbent is ... prepares, analyses, and/or develops mitigation strategies for review with clinical partners and senior leaders. + Responsible...for all study product needs (Bulk Drug Product and Clinical Finished Goods). + Responsible… more
- Bristol Myers Squibb (Cambridge, MA)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Senior Director will be the clinical lead to progress multiple early ... with Global Development Operations/Global Compliance Group to develop asset level risk management plan, resolves issues with Quality/ Clinical Scientists, and… more
- Sanofi Group (Cambridge, MA)
- The Senior Clinical Research Director (Sr CRD) is noted as the primary clinical lead for dermatology programs. The role requires a well-organized, strategic ... deliver to multiple operational tasks. The role of the Senior CRD is to: + Act as a mentor...test and cluster feasibility, medical review and validation of clinical data, study risk assessment) + Contribute… more
- Bristol Myers Squibb (Cambridge, MA)
- …and execution of multiple clinical trials (eg significant experience as a senior clinical leader), and exhibits all of the following attributes: + Able ... their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Clinical Development Lead sits within Clinical Development, which is… more
- Amgen (Cambridge, MA)
- …patients worldwide. It's time for a career you can be proud of. ** Senior Manager, Systems Engineering - Combination Product Development** **Live** **What you ... the Senior Manager, Systems Engineering (SMSE) in the Combination Product Operations organization. The Systems Engineering team guides in the identification,… more
- Wolters Kluwer (Boston, MA)
- …Drive transparency to roadmap detail, progress, roadblocks, etc. (across partners, Agile teams, senior leadership, etc.) + Sequence the Product Roadmap to ensure ... to use your skills and talent to identify and develop concepts that help improve clinical outcomes? If your answer is yes, come and join our dynamic team! Wolters… more
- Commonwealth Care Alliance (Boston, MA)
- **Why This Role is Important to Us:** Senior Product Owner will review documentation and provide feedback on quality and accuracy related to the Ancillary and ... Pharmacy Information Technology (IT) product portfolio and is responsible for consulting with CCA's...opportunities to attain operational efficiencies and growth opportunities. The Senior PO will lead a portfolio of projects and… more
- Olympus Corporation of the Americas (Westborough, MA)
- …purpose and our core values by staying **True to Life.** **Job Description** As a Senior Global Product Manager, Digital Unit for our Healthcare Product - ... with development teams to ensure development and delivery timelines are met. . Conduct risk and quality management assessments at a product level. + ** Product… more
- Olympus Corporation of the Americas (Westborough, MA)
- …with development teams to ensure development and delivery timelines are met. Conduct risk and quality management assessments at a product level. + **Development ... and our core values by staying **True to Life.** **Job Description** As a Global Product Manager of Digital Unit, you have a unique opportunity to make a meaningful… more
- J&J Family of Companies (Boston, MA)
- … clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements. The Senior Local Trial ... Senior Local Trial Manager - Immunology - 2406178158W...(Sr. LTM) is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in… more
- Point32Health (Canton, MA)
- …are at Point32Health, click here (https://youtu.be/S5I\_HgoecJQ) . **Job Summary** The Senior Contract Manager will support all Lines of Business, including ... Commercial, Senior Products and Public Plans. The Senior ...aspects such as unit cost trend, alternative payment methodologies, risk arrangements such as trend-based risk and… more
- J&J Family of Companies (Boston, MA)
- …Affairs portfolio. Our activities include all in-house and outsourced manufacturing of clinical supplies (API, Drug Product , Packaged and Labeled Clinical ... to more than 60.000 patients in more than 330 clinical trials every year. As a Senior ...Clinical Trial Material supply plans. + Create drug product and drug substance supply plans by aggregating … more
- Takeda Pharmaceuticals (Boston, MA)
- …function in the development, implementation and refinement of a proactive and risk -based quality operating model for Takeda's clinical research (GCP), ... to the best of my knowledge. **Job Description** **Job Title** : Head, Clinical and Safety Quality Compliance **Location** : Cambridge, MA or Zurich, Switzerland… more
- J&J Family of Companies (Raynham, MA)
- …highly preferred: + Test method development, validation, and execution + Product specification development and requirements management + Risk identification ... Senior Development Engineer, INTO - 2406181942W **Description** At...of products necessary to deliver against the agreed-upon Target Product Profile (TPP) for cancer treatment. They will work… more
- ConvaTec (Lexington, MA)
- …all our general medical affairs activities, including, but not limited to new product development, evidence generation and review, risk management, and other ... studies. + Deep understanding of the medical device industry and of product development, including research, clinical , quality, marketing and regulatory… more
- Candela Corporation (Marlborough, MA)
- …to senior management. . Identify project risks and develop risk response strategies including scope, schedule, and resource accommodations. . Manages ... ** Senior Program Manager** Requisition Number **2756** Location **US...a leading global aesthetic device company with a comprehensive product portfolio and a global distribution footprint. We are… more
- CVS Health (Wellesley, MA)
- …assess, communicate, and resolve complex problems and facilitate issue resolution and risk mitigation. * Knowledge of clinical interoperability and/or external ... personal, convenient and affordable. Position Summary As a member of the Clinical Informatics and Interoperability team you will be responsible for the coordination… more
- Pfizer (Cambridge, MA)
- …optimize clinician resource utilization across indications + In conjunction with the Safety Risk Lead, ensures patient safety during clinical trial conduct plus ... Operations (CD&O), develops effective mitigation plans + In conjunction with the Safety Risk Lead, ensures patient safety during clinical trial conduct plus… more