- Pfizer (Cambridge, MA)
- …governance meetings and submissions, partners with/supports the Development lead/Medical Director regarding study and disease area strategy. Author protocols, study ... contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; supports… more
- Takeda Pharmaceuticals (Boston, MA)
- …transformative medicines and make a lasting impact on patients worldwide. Join Takeda as a Senior Director , Global Regulatory Lead - Oncology, where you ... will be part of the global regulatory team. In this influential role,...expert advice and technical support from functional stakeholders and senior management. + Acts independently under the direction of… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** **_Objective / Purpose:_** + Defines, develops and leads global strategies to maximize global regulatory success towards ... and influencing the field as applicable. + Provides leadership and development for other global regulatory leads responsible for the design and execution of … more
- Bristol Myers Squibb (Cambridge, MA)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . **Sr Director , Global Regulatory Strategy, Neuroscience** + Will be a ... Support due diligence and business development assessments. + Working with regional regulatory staff as Global Regulatory Lead and US Regional Regulatory … more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …post commercialization, with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director , GCD is responsible for ... **Job Description** **Position Summary** Otsuka is seeking an experienced and visionary Senior Director , Global Clinical Development (GCD), with experience… more
- Takeda Pharmaceuticals (Boston, MA)
- …transformative medicines and make a lasting impact on patients worldwide. Join Takeda as a Director , Global Regulatory Lead Oncology where you will be part ... of the global regulatory team. As ...of the global regulatory team. As Director , ...Strong ability to work well with others and within global teams; and acceptable at communicating with senior… more
- Sanofi Group (Cambridge, MA)
- …around the world. Reporting to the Global Medical Lead for Tolebrutinib, the Global Senior Medical Director for Life Cycle Management (LCM) will oversee ... enrollment and follow-up, budget tracking). In addition, the LCM senior director will be the global...and dissemination plan (primary and secondary results), interaction with global regulatory agencies and collaboration with the… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be ... coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight...issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA ... promotion. **How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising...if there is new data or campaigns that require senior level management input or alignment. + Strategic business… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **OBJECTIVES/PURPOSE:** Reporting to the Head, Global Regulatory Operations (GRO), the Head of Global ... system reach and adoption, and enhancing efficiency through data connectivity across Global Regulatory Affairs (GRA), Research & Development (R&D), and the… more
- Takeda Pharmaceuticals (Boston, MA)
- …innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Director , Global Program Leader - Oncology, Solid Tumors in our ... be experienced, versatile and strong enterprise leaders + Committed to simultaneously driving regulatory approval as well as launch and global patient access +… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA ... GRA A&P SME for assigned products and projects. + Regulatory advisor as the "R" in the core Medical,...and implementation + Product or project business lead for global CMRP at Takeda + CMRP Meeting Chair- pausing… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …and engaging training ecosystem that enhances employee learning experiences and supports regulatory compliance. + Oversee the development and global deployment ... technologies (eg, LMS, LXP, AI-based learning tools). + Ensure global training programs meet regulatory inspection readiness...& Development, with at least 5 years in a senior leadership role in a regulated industry (pharmaceutical, biotech,… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …Description - Aligning with the strategic goals of the GQ organization, the Sr. Director of Global Quality Solutions (GQS) is responsible for understanding and ... driving efficiency across Global Quality's processes and operations via automation and digitization;...GQ systems, future processes and teams. - The Sr. Director position will facilitate continuous improvement activities within GQ… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …+ Therapeutic area knowledge relevant to mechanism of action + Regional/ global Regulatory requirements + Emerging research in designated therapeutic ... of your future at Takeda. Join us as a Senior Medical Director - GI & Inflammation- Rheumatology,...Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical,… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Senior Clinical Research Director **Location:** Cambridge, MA or Morristown, NJ **About the Job** Join the engine of Sanofi's mission - where deep ... turn the impossible into possible for millions. As the ** Senior Clinical Research Director ** ( Senior ...of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other… more
- Sumitomo Pharma (Boston, MA)
- … Regulatory Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will primarily ... function as a regional regulatory leader (RRL) and/or Global ...Comfortable presenting to all levels of the organization including Senior Management. **Education and Experience** + Bachelor's degree in… more
- Bristol Myers Squibb (Cambridge, MA)
- …. **Position Summary** The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy for biomarkers ... Drive the development and actively support the execution of innovative, compliant global regulatory strategies that enable cutting-edge biomarkers and diagnostic… more
- Takeda Pharmaceuticals (Boston, MA)
- …area knowledge relevant to mechanisms of action of compounds in remit + Regional/ global Regulatory requirements + GCP/ICH + Emerging research in designated ... and empower you to shine? Join us as a Senior Medical Director , Solid Tumor in our...Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical,… more
- Otsuka America Pharmaceutical Inc. (Waltham, MA)
- **Job Summary** The Senior Director will serve as the Translational Medicine CNS Therapeutic Area Head, reporting to the VP, Translational Medicine and Early ... Clinical Development within OPDC's Early Development Organization (EDO). The Senior Director Translational Medicine will oversee a small team of CNS… more
