- Eisai, Inc (Boston, MA)
- …budgeting, vendor management, and technical oversight to support the objectives of Global Regulatory Operations. The Associate Director will collaborate with ... difference. If this is your profile, we want to hear from you. The Associate Director of Global Submission Management (GSM) is responsible for leading, managing,… more
- Merck & Co. (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 Director … more
- Sanofi Group (Framingham, MA)
- **Job title** : Global Regulatory Affairs Device Lead ( Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the ... could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting the medical… more
- Sumitomo Pharma (Providence, RI)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , 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… more
- GRAIL (Providence, RI)
- …products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and review of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties as assigned. **Required… more
- Takeda Pharmaceuticals (Boston, MA)
- … strategies in collaboration with their regional counterparts. **Accountabilities:** + The Associate Director will be responsible for complex or highly complex ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- Takeda Pharmaceuticals (Boston, MA)
- …the development of scientific communications strategy and deliverables, the ** Associate Director , Scientific Communications Lead, Hematology** proactively ... deliver your best. As part of the Global Medical Affairs Oncology team, you will report to the Scientific...in life sciences, and excellent project management skills. The Associate Director , Scientific Communications Lead, develops and… more
- Takeda Pharmaceuticals (Boston, MA)
- …transformative medicines and make a lasting impact on patients worldwide. Join Takeda as Associate Director , Global Regulatory Lead Oncology where you will ... be part of the global regulatory team. As Associate Director ,...regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization… more
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- The Associate Director of Regulatory Intelligence leads the collection and dissemination of regulatory intelligence and collaborates with SMEs to ... + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and strengthen and… more
- CSL Behring (Waltham, MA)
- …and protect CSL's reputation and policy position. **Reporting Relationships:** **Reports to:** Associate Director , Corporate & External Affairs , R&D ... **Position Title:** Senior Manager, Corporate & External Affairs , R&D Portfolio **Position Purpose:** The Senior Manager,...Portfolio **Main Responsibilities and Accountabilities:** + Support the Associate Director in serving as a business… more
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- …needs and nutraceutical products for the maintenance of everyday health. As an Associate Director , Biostatistician, you will be a champion of Otsuka's culture ... statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues,… more
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- **Job Summary** The Associate Director , Global Product Quality - GMP Process is responsible for enabling the optimization and harmonization of key GMP quality ... alignment with corporate quality objectives + Cross-functional Leadership:Collaborate with Regulatory Affairs , Technical Operations, Manufacturing, and Supply… more
- Takeda Pharmaceuticals (Boston, MA)
- …Japan Payer Marketing and Market Access, Global Evidence and Outcomes, Medica Affairs , Clinical Development, Regulatory Affairs , Biostatistics, Global ... leadership at LOC level Decision-making and Autonomy + Responsibility in line with Associate Director level position; independently lead HE projects and support… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …remotely from a New England state (ME, VT, NH, MA, CT, RI).** The Associate Director , Office for Human Research Studies (OHRS), oversees operational activities ... degree required; degree in Public Health, Life Sciences, Health/Research Administration, Regulatory Affairs , Bioethics, Health Law, or related field preferred.… more
- Rhythm Pharmaceuticals (Boston, MA)
- …to overcome barriers, together. Opportunity Overview We are seeking an experienced Associate Director , Scientific Communications as part of the North America ... Medical Affairs team to lead the strategic planning and execution...North America Medical team, reporting to the Senior Medical Director , North America, you will be accountable for advancing… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **About the role:** The Associate Director , Clinical & Quality Process Compliance is responsible for ensuring ... and monitoring processes, and ensuring compliance with corporate and regulatory standards. By maintaining high-quality standards, this role supports Takeda's… more
- Takeda Pharmaceuticals (Boston, MA)
- …DP/PKG** **Location: Cambridge, MA** **About the role:** As a Process Scientist ( Associate Director ) - Global Manufacturing Science GMSci Drug Product (DP), ... Manufacturing Sciences + Global Manufacturing Supply, Global Quality and Global Regulatory Affairs . + SME for Takeda drug product manufacturing organization and… more
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- …to address strategic objectives to business partners. + Work closely with medical affairs , marketing, and IT teams to ensure alignment and integration of omnichannel ... Research, Analytics, Otsuka Information Technology (OIT), Sales Operations, and Medical/ Regulatory /Legal integrated business partners. **Minimum Qualification:** + Bachelor's degree… more
- State of Massachusetts (Boston, MA)
- …against licensees who engage in professional misconduct when necessary. The Executive Director ("ED") for MSAC reports to the Associate Deputy Commissioner ... Provide written and oral advice to the Agency on regulatory matters related to MSAC. * Establish and maintain...records unit with filling these requests. * Assist the Director of External Affairs and the OCA… 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 Director… more
