- Sanofi Group (Cambridge, MA)
- …questions from health authorities, ethics committees, IRBs, external partners + Management of product safety alerts + Ensuring the GPE position is well ... action plans and implementation, as appropriate + Enable effective development of product safety + Enable appropriate risk management + Enable up-to-date risk… more
- Sanofi Group (Cambridge, MA)
- …from health authorities, ethics committees/ IRBs, external partners + Management of product safety alerts + Ensuring the GPV's position is well ... + Provide PV and risk management expertise to internal and external customers + Safety expert for product must have an attitude of continuous learning and… more
- GE HealthCare (MA)
- …initiated research (eg, FAPI Research), including tracking of submissions, progress, enrolment, product supply, budget, and safety reporting. + Facilitate the ... oversight and strategic management of Global Outreach Research programmes and Investigator Sponsored Trials (ISTs) involving unapproved PDx products. In addition to… more
- Sanofi Group (Cambridge, MA)
- …CMO reporting and cross-GBU initiatives related to ESR. + Supports dissemination of safety updates and Dear Investigator Letters (DILs). + Ensures stakeholders ... external sponsor) for Externally Sponsored Research (ESR) support, including Investigator Sponsored Studies (ISS) and Externally Sponsored Collaborations (ESC). The… more
- Lilly (Boston, MA)
- …the reporting of adverse events as mandated by corporate patient safety ; the review process for protocols, study reports, publications, regulatory submissions ... Collaborate with the Preclinical groups, Clinical Pharmacology, Health Outcomes and New Product Planning in the development and maintenance of Draft Launch Labels… more
- Sanofi Group (Cambridge, MA)
- …Business Development, Regulatory, etc. to facilitate diligence reviews, medical and safety evaluation, product positioning, lifecycle evidence planning, and ... to enhancement of Sanofi's scientific messages, plans, strategy, systems, and product development. + Maintain awareness of and assesses emerging evidence in… more
- Philips (Cambridge, MA)
- …teams, including Marketing, Quality, Regulatory, and Clinical Affairs, to drive product advancement, ensure safety and performance, and support global ... teams, such as Marketing, Quality, and Clinical Affairs, to drive product enhancement, maintain compliance, and proactively share competitive and scientific insights… more
- AbbVie (Cambridge, MA)
- …generate, deliver, and interpret high-quality clinical data supporting overall product scientific and business strategy. Responsibilities + With appropriate ... protocols for a clinical development program in support of the overall Product Development Plan, based on strong medical and scientific principles, knowledge of… more
- Pfizer (Cambridge, MA)
- …and Precision Medicine, Oncology Clinical Development and Operations, Pharm Sci and Product Teams. + Oversee the evaluation of safety , pharmacology, and ... teams responsible for the development of early development assets (including Product Team). + Oversee the development and management of clinical protocols… more
- Sanofi Group (Cambridge, MA)
- …based in Morristown, NJ or Cambridge, MA. The role functions internally as the product expert to lead the development and execution of the most efficient and ... objectives. + Reviewing and approving medical and scientific content of Regulatory, Safety , Scientific Affairs, Medical Affairs, and Commercial. + Ensuring that all… more