- 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
- Merck & Co. (Boston, MA)
- …studies.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Clinical Director May Be… more
- Rhythm Pharmaceuticals (Boston, MA)
- …to adapt, learn, and our tenacity to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you will be ... and life cycle of Rhythm products. This role reports into the Director , Global Regulatory Affairs . Responsibilities and Duties + Act as the Global… 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
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA A&P) ... GRA A&P SME for assigned products and projects. + Regulatory advisor as the "R" in the core Medical,...advisor as the "R" in the core Medical, Legal, Regulatory review functions of the Commercial Material Review Process… 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
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- The Director , Strategic Planning & Operations is a pivotal role within the Medical Excellence & Operations team within Global Medical Affairs . This role is ... the asset lifecycle. This role reports directly into the Executive Director , Medical Excellence and Operations. **Job Description** **Key Responsibilities Include:**… more
- Takeda Pharmaceuticals (Boston, MA)
- …company that will inspire you and empower you to shine? Join us as an Associate Director , Global Regulatory Project Management and Strategic Planning - ... Oncology TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory … 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
- Lilly (Boston, MA)
- …year. Verve is headquartered in Boston, Massachusetts. **The Position** The purpose of the Associate Director , Regulatory Strategy role is to support the ... accountable for submissions, and taking part in meetings. + Represent the regulatory affairs team on cross-functional project teams and provide guidance to and… more
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- The Associate Director , Congress and Medical Education Strategy & Execution is responsible for executing and contributing to the global medical strategy and ... patient outcomes through deep scientific understanding and collaborative partnerships. The Associate Director partners closely with global and regional… more
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- The Associate Director , Scientific Communications manages the execution of the core scientific and medical communications strategy for the relevant therapeutic ... accurate, evidence-based, and compliant with internal policies and external regulatory requirements. + Collaborate cross-functionally with Medical Affairs ,… 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
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for ... and assures that Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions + Manages… 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
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- ** Associate Director , Small Molecule Analytical Development** + Lead and oversee phase appropriate method development and optimization for drug substance and ... cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to… 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)
- …true to the best of my knowledge. **Job Description** **About the role:** Associate Director , Clinical Program Quality Investigations is responsible for ensuring ... for clinical deviation management, and Serious Breaches investigation and reporting to regulatory agencies. + Act as strategic partner to Clinical Program Quality… more
