- Cytel (Cambridge, MA)
- …team of consultants and analysts. + Experience interacting with regulatory agencies ( FDA /EMA) and key opinion leaders to enhance development plans. + Collaborative, ... entrepreneurial and self-motivated, with an understanding of the dynamics of high-growth companies; the ability to work effectively in a challenging and sometimes rapidly changing environment. + Minimum of a Masters in Mathematics, Biostatistics, or a related… more
- Bristol Myers Squibb (Devens, MA)
- …Comprehensive knowledge of SOPs, cGMPs and other compliance requirements and regulatory guidelines ( FDA , EU) and the know how to work and manage within a regulatory ... environment. + Demonstrated leadership skills and the ability to negotiate in a complex environment. + Demonstrated track record of IT Support in a fast-paced regulated environment supporting benchtop instruments, quality and lab applications. + Excellent… more
- Fujifilm (Boston, MA)
- …II + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications:** Professional Experience: + 5-10 years… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. Key Performance Indicators: + Revenue and sales bookings… more
- Astrix Technology (Boston, MA)
- …submissions (eg, INDs, CTAs) and provide medical input in alignment with FDA , EMA, and ICH guidelines. + Collaborate with cross-functional teams, including ... preclinical, clinical operations, and regulatory affairs, to integrate and execute clinical strategy. + Represent the organization in scientific forums such as advisory boards, steering committees, and DSMBs. + Engage with key opinion leaders to guide clinical… more
- Sanofi Group (Cambridge, MA)
- …the GPT are conducted in compliance with current regulations, laws, and guidance from FDA , EMeA, and CHMP, as well as with Sanofi's policies and procedures. **About ... You** **Basic Qualifications** Required Qualifications * Bachelor's Degree required. Medical Doctor preferable, or PhD in relevant area * 10 years of business-related experience is required * 6+ yrs of experience in drug development within a therapeutic area… more
- United Therapeutics (Boston, MA)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an… more
- United Therapeutics (Boston, MA)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an… more
- ThermoFisher Scientific (Agawam, MA)
- …are met. + Ensures storage of materials is in keeping with State and Federal FDA , Board of Pharmacy, DEA, ATF, EPA and OSHA regulations. + Delivers with decision ... making skills, resolving problems that prevent a timely and efficient handling of inbound and outbound orders. Makes recommendations regarding workflow and overtime when needed. Applies problem solving methodology to address site specific problems impacting… more
- United Therapeutics (Boston, MA)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an… more