- 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
- Takeda Pharmaceuticals (Boston, MA)
- …with functional experts across the R&D organization, such QS, Research, Biostatistics, Regulatory Affairs , DMPK, Pharm Sci, and Clinical Science providing ... vital contributor to our inspiring, bold mission. **Position Objectives:** + The Senior Director manages strategic, scientific and operational aspects of… more
- Merck (Boston, MA)
- …scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations) + ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- Takeda Pharmaceuticals (Boston, MA)
- …into reality. + Strong understanding of Clinical Trial Delivery and/or Regulatory Affairs /Operations business processes and supporting technology platforms + ... to the best of my knowledge. **Job Description** **_OBJECTIVES/PURPOSE:_** The Senior Product Manager role involves aligning business and technology stakeholders to… more
- Cole-Parmer (Franklin, MA)
- …product line development in collaboration with Research & Development, Operations, Regulatory Affairs and Commercial teams. Implement appropriate programs to ... Job Title: Senior Product Manager, Job Title: Senior ...internal MolDx sales team and global distribution channels. + Scientific marketing for the assigned portfolio and markets, including… more
- J&J Family of Companies (Cambridge, MA)
- …https://www.jnj.com/innovative-medicine Johnson & Johnson Innovative Medicine is recruiting for ** Senior Director, R&D Data Science & Digital Health - ... at https://www.jnj.com/ . **Role Summary** We are seeking an experienced and visionary ** Senior Director** to lead our data science and digital health strategy for… more