- Teradata (Boston, MA)
- …**What You'll Do** Teradata is seeking a hands-on, data-driven Sr. Director , Partner Marketing & Demand Generation to lead co-marketing, demand generation ... Key Responsibilities + Collaborate with strategic partners (eg, Microsoft, AWS, GCP ) to plan and execute joint marketing initiatives including in-person events,… more
- Takeda Pharmaceuticals (Boston, MA)
- …research, including but not limited to US CFR, EU CTD, and ICH GCP . Awareness of local country requirements is also required. **Skills:** + Demonstrated excellence ... in program management, including scenario assessment, risk assessment and contingency planning + Demonstrated excellent matrix leadership and communication skills + Able to influence without authority + Excellent teamwork, communication, organizational,… more
- Pfizer (Cambridge, MA)
- …in Early Development + Strong knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations. + Strong scientific ... writing skills and communication skills (written and verbal) + Clinical document writing experience (eg, protocol, ICD, IB, IND), as well as understanding complex data analysis. + Track record of scientific productivity as evidenced by publications, posters,… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Clinical Operations. + Familiarity with relevant regulations and standards (eg, GCP , GDPR, Sunshine Act, clinical trial transparency, research compliance). + ... Experience with research governance systems or platforms for intake, study tracking, and document management. + Experience working in a global cross-functional team (functional/matrix) environment and knowledge and/or experience working with groups with varied… more
- Bristol Myers Squibb (Cambridge, MA)
- …documents + Champions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conduct + Represents Clinical Development ... in both internal and external forums as the consulted authority for the disease area, including within Business Development function + Partners with Worldwide Patient Safety physicians in the ongoing review of safety data + Serves as the (co-)leader of the… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …of Quality/Compliance experience. + Advanced knowledge of clinical research ( GCP ), pharmacovigilance (GVP) and medical throughout R&D and commercialization, and ... relevant regulations. + Preferably with experience in strategic roles involving quality systems and clinical portfolio oversight, large-scale audit programs, regulatory inspection management, investigation and remediation activities on a global level and… more
- Celestica (Boston, MA)
- …development methodologies (eg, Agile, Scrum), cloud computing (AWS, Azure, GCP ), data architecture, cybersecurity, and modern, secure programming languages. GenAI, ... vibe coding and other modern means of software development. + Customer Focus: Excellent communication, interpersonal, and presentation skills, with a proven ability to build strong customer relationships. + Quality Advocate: Deep understanding of quality… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Job Summary** Under the direction of the Director /Associate Director of Clinical Management, the Senior Clinical Study Manager is responsible for the oversight ... to applicable regulations and guidance; ICH Guidelines Good Clinical Practices ( GCP ), and Otsuka SOPs, within agreed-upon timeframes and budget. **Job Description**… more
- Parexel (Boston, MA)
- …close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and ... in compliance with Client Procedural Documents, international guidelines such as ICH- GCP , and relevant local regulations and that the sites deliver according… more
- Parexel (Boston, MA)
- …study execution in accordance with applicable prevailing laws, Good Clinical Practices ( GCP ), and sponsor standards. The Sr. CRA is accountable for site management ... quality of investigator sites (eg patient safety, site quality and compliance with GCP ), to maintain investigator and site staff engagement and satisfaction, and to… more