- Takeda Pharmaceuticals (Boston, MA)
- …in regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively ... on patients worldwide. Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of...resource gaps for assigned project(s). + May present to senior management as requested. + Participate with influence in… more
- Merck (Boston, MA)
- …innovative medicines, and we work with cross-functional colleagues in Global Medical and Scientific Affairs and Global Policy to ensure timely and equitable ... process (mainly Phase 2-3) including study design, medical monitoring, and medical/ scientific interpretation of study analyses, regulatory reporting, and… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and ... a scientific or technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years' work experience in regulatory … more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …external engagement across therapeutic areas + Collaborate with global and US Medical Affairs teams to ensure alignment with scientific and commercial priorities ... The Senior Manager, External Engagement Strategic Planning will play...executing strategic initiatives that enhance the impact of Medical Affairs external stakeholder engagement activities (including those of the… more
- Merck (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Senior Director May… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …including INDs, IBs, clinical study reports, and NDAs/BLAs. + Collaborate with regulatory affairs on interactions with global health authorities. + Provides ... with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD...programs after proof of concept through late-stage trials and regulatory submissions. + Provide medical and scientific … more
- Merck (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior … more
- Sanofi Group (Waltham, MA)
- …activities (when applicable), including quality, relevance to external stakeholders (eg regulatory authorities, medical journals), and scientific validity. We ... **Job Title:** Senior Project Biostatistics Lead- Vaccines **Location:** Waltham, MA...+ Contribute with project team members (ie: clinical, pharmacovigilance, regulatory , ) to gain Health Authorities acceptance of the… more
- Sanofi Group (Cambridge, MA)
- …organization and priorities and 3) trends in environment and competition + The Senior COA Lead actively participates in the regulatory and commercial dynamic ... instruments; the development of briefing books or dossiers for regulatory consideration of COAs Internal customers include primarily Research...guidance and support to the COA scientists. + The Senior COA Lead is accountable for scientific … more
- Edwards Lifesciences (Boston, MA)
- …and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more