- Bristol Myers Squibb (Devens, MA)
- …Director, CTTO, and interface with Drug Product Development, Operations, Quality, Regulatory , MS&T, and other colleagues globally. **Key Responsibilities** + Own the ... strategy, commercial objectives, and technical innovation. + Serve as technical lead for post-market process changes, technology transfers, and process optimization… more
- Pfizer (Cambridge, MA)
- …team in governance meetings and submissions, partners with/supports the Development lead /Medical Director regarding study and disease area strategy. + Author ... contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; supports… more
- Pfizer (Cambridge, MA)
- …mentor teams and collaborate with diverse stakeholders in oncology. + Experience with global I&I regulatory submissions and interactions with major regulatory ... provide strategic direction, foster cross-functional collaboration, and mentor a high-performing global Development team. The successful candidate will be a hands-on… more
- Hologic (Marlborough, MA)
- …Audit Program, ensuring compliance with FDA regulations, ISO standards, and other global regulatory requirements. If you thrive in a fast-paced, collaborative ... (21 CFR 820), ISO standards (eg, ISO 13485:2016, ISO 14971), MDSAP, and other global regulatory requirements. + Expertise in Quality Systems and GMP compliance… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …The Executive Director, Medical Affairs Strategy, Excellence & Operations will lead five critical teams: Strategic Planning, Business Solutions & Analytics, Vendor ... & Contracts Management, Governance & Procedures, and Global Medical Evidence Operations ensuring alignment with enterprise goals and medical excellence priorities.… more
- Sanofi Group (Cambridge, MA)
- …across TAs. + Plan and execute Franchise's participation in key international congresses. + Lead and manage global digital initiatives for the Franchise. + Set ... some of the highest unmet needs. Reporting to the Global Head of Immunology, the Head of Strategy &...goals. The individual in this position will initiate and lead strategic workstreams and be responsible for strategic deliverables,… more
- Sanofi Group (Cambridge, MA)
- …the Job** The Director, Portfolio Strategy & Evolution (PS&E) reports to the Global Head of Portfolio Strategy & Evolution within the Specialty Care Rare Diseases ... Diseases. He/she will be a core member of the Global Project Teams and provide Commercial leadership and strategic... Project Team core member, collaborate with R&D, Medical, regulatory , CMC, HEVA and MAxP and represent NPP/Commercial on… more
- Takeda Pharmaceuticals (Lexington, MA)
- …functions and device development teams + Serve as clinical liaison to Global Device Team, including engineering, regulatory affairs, quality, and commercial ... to regulatory and quality standards, and patient-focused innovation. + Lead , mentor, and develop organization on device clinical development best practices,… more
- Teleflex (Chelmsford, MA)
- …controls, and production documentation to ensure compliance with internal procedures and regulatory standards. * Lead the execution of validation activities ... : Up to 10% **Requisition ID** :12983 **About Teleflex Incorporated** As a global provider of medical technologies, Teleflex is driven by our purpose to improve… 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
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