- GE HealthCare (Boston, MA)
- …Imaging & Digital Group, within the R&D department of GE HealthCare's Pharmaceutical Diagnostics (PDx) business segment, which develops and markets a broad portfolio ... & Digital Group (including imaging operations, and in the development of novel analytical tools) and the broader R&D...within PDx clinical study teams, with medical affairs and product leaders + Travel to international and domestic clinical… more
- Takeda Pharmaceuticals (Boston, MA)
- …3 years of experience in GCP Quality/Compliance. + Advanced knowledge of pharmaceutical development , medical affairs and GCP/GVP regulations including FDA, EU, ... Quality Compliance is responsible for ensuring the quality of processes and product outputs. This role involves defining and specifying activities, processes, and… more
- AbbVie (Worcester, MA)
- …to lead site analytics web and data quality initiatives within our pharmaceutical operation reporting into Digital Systems organization. This role is central to ... Implement and maintain Data Integrity compliance activities across the end-to-end product lifecycle and various departments in alignment with relevant regulatory… more
- Takeda Pharmaceuticals (Boston, MA)
- …clinical trial development through the marketing maintenance phase of a product lifecycle + Subject matter expert on EFPIA, IFPMA, and FDA code/regs, guidance, ... Commercial Material Review Process (CMRP). Provide regulatory guidance during development , review, approval, and implementation of medical and commercial materials.… more
- Sanofi Group (Cambridge, MA)
- …support seamless launch execution _Channel Strategy & Execution_ + Support development and implementation of product -specific distribution strategies (eg, ... degree required; MBA or advanced degree preferred + 5+ years of pharmaceutical industry experience, including product launch support, trade & distribution,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …personnel and activities for assigned products in therapeutic area to include development of written and verbal responses, including clinical dossiers. + Responsible ... with medical strategy (Medical Director, Scientific Director) personnel in the development / execution of medical communications and research activities and leads… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …best of my knowledge. **Job Description** You will sit in the The Global Product & Launch Strategy (GPLS) group is part of our Global Portfolio Division comprised ... spanning over 70 countries. Our GPLS organization is responsible for our global product strategy organization focused on fueling the growth of Takeda through our… more
- Takeda Pharmaceuticals (Boston, MA)
- …8 years+ of experience gained in Pharmacovigilance, Clinical Research, or Clinical Development within the Pharmaceutical industry and/or academia and/or CRO ... (GSL) and PV Scientists for a compound that is **both in clinical development and marketed** in the designated therapeutic area. **How you will contribute:** +… more
- Bristol Myers Squibb (Cambridge, MA)
- …+ Experience gathering and communicating user feedback to inform enterprise AI/LLM product development . + Demonstrated ability to lead change management ... senior manager will support programs that span early discovery through development candidate identification and recommendation for development . **Key… more
- Sanofi Group (Cambridge, MA)
- …The Director plays an active role in shaping labeling strategy early in product development by providing regulatory input into clinical development ... race is on to speed up drug discovery and development to find answers for patients and their families....(eg, CCDS, USPI, SmPC) for assigned products throughout the product lifecycle. + Provide regulatory labeling leadership to cross-functional… more