- Bristol Myers Squibb (Devens, MA)
- …partner with operational teams to ensure compliance with Bristol-Myers Squibb policies, standards , procedures, and Global cGMP. The Manager, Shop Floor Quality ... the Cell Therapy Facility in accordance with Bristol-Myers Squibb policies, standards , procedures, and Global cGMP. Functional responsibilities include ensuring… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …report (FSR), including authoring statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design ... **Job Summary** Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health… more
- Sumitomo Pharma (Boston, MA)
- Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the US (Sumitomo Pharma America, Inc.), focused on addressing patient ... a dynamic, highly motivated, and experienced individual for the position of **Manager, Clinical Systems R&D IT Business Applications** who will serve as the primary… more
- Oracle (Boston, MA)
- …and administered across care settings worldwide. By embedding intelligent automation, clinical decision support, and data -driven insights into our products, ... with data analytics, AI/ML-enabled decision support, and healthcare interoperability standards (ex. NCPDP, HL7, FHIR) + Knowledge of regulatory and compliance… more
- Takeda Pharmaceuticals (Boston, MA)
- …a portfolio of platforms and products-such as Regulatory Information Management (RIM), Clinical Operational, Clinical Data Products, and supporting ... and executing the vision, strategy, and delivery of technology solutions that enable global R&D, Regulatory, or Global Development functions. This role owns… more
- Oracle (Boston, MA)
- …and save lives. Our mission? To create a human-centric healthcare experience powered by unified global data . It's a big challenge, but big challenges are what we ... leaders, end users, and technical teams. + Ability to analyze healthcare data , integrate industry standards , and translate insights into actionable… more
- Pfizer (Cambridge, MA)
- …to discover, validate and implement novel translation biomarker strategies to support data -driven decisions in clinical development + Demonstrated excellence in ... of researchers to create a portfolio of discovery projects from ideation to clinical candidate nomination. This highly visible leader will develop a data -driven… more
- Candela Corporation (MA)
- …MBA (preferred) 2.5+ years in product marketing with 2+ years with global responsibility **Essential Job Requirements: (Mandatory for Clinical and Regulatory ... messaging, shaping go-to-market strategies, and ensuring commercial readiness across global markets. Responsibilities also include enabling sales teams, generating… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …committees and with external experts/committees. The role is accountable for overseeing data generation activities, including phase 4 clinical studies, providing ... and in alignment with the commercial brand strategy and global product teams + Collaborate with Value and Evidence...industry at large. + Commitment to upholding the highest standards of data privacy, ethics, and regulatory… more
- Takeda Pharmaceuticals (Boston, MA)
- …the speed and success of R&D growth and strengthens competitiveness. R&D Data & Quantitative Sciences encompasses several global functions, including ... in interactions with regulatory agencies + Advanced knowledge of clinical study designs, analysis methodology and data ...Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical… more