- Parexel (Boston, MA)
- …Leader, Parexel!** In anticipation of future needs, we are seeking an additional Associate / Medical Director to join Parexel's highly recognized Medical ... our Global Immunology and Inflammation Therapeutic Franchise! As an Associate / Medical Director , you will work...conduct or protocol + Review and sign off all data listings / tables, protocol deviations, datasets, for medical… more
- Commonwealth Care Alliance (Boston, MA)
- …Duties & Responsibilities: The Manager, Utilization Management reports to the Director of Utilization Management - Oversees clinical decision review for services ... Ensures timely and appropriate determinations of medical necessity, adhering to regulatory and contractual requirements. - Maintain up-to-date knowledge of and… more
- Takeda Pharmaceuticals (Boston, MA)
- …application is true to the best of my knowledge. **Job Description** **Summary:** The Regulatory Data Governance Lead will ensure Regulatory information and ... stewardship, governance, and compliance. **Responsibilities:** **1. M&A Integration and Regulatory Data Transfer** + Coordinate the assessment, transfer, and… more
- Sumitomo Pharma (Boston, MA)
- …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...nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/ data ) and contributes to content as needed + Advises… more
- Takeda Pharmaceuticals (Boston, MA)
- … strategies in collaboration with their regional counterparts. **Accountabilities:** + The Associate Director will be responsible for complex or highly complex ... to regulatory requirements and strategy. + Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned… 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 Job** ... skills 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
- 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 - ... into regulatory information management systems, preparing, checking and tracking regulatory data and lists etc.) + Prepare and deliver reports and metrics on… more
- Takeda Pharmaceuticals (Boston, MA)
- …is true to the best of my knowledge. **Job Description** **Job Title:** Associate Director - Analytics, Global Regulatory Affairs **Role Purpose:** ... and operational oversight of custom analytics deliveries from Global Regulatory Affairs involving Business Intelligence solutions and related semantic layer… more
- Takeda Pharmaceuticals (Boston, MA)
- …is 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,...cannot come to alignment or if there is new data or campaigns that require senior level management input… more
- United Therapeutics (Boston, MA)
- …like lungs, pancreases and hearts. **Who you are** We are looking for a regulatory strategist who will advise on regulatory pathways, managing documentation and ... timelines, and supporting the preparation and execution of regulatory submissions for our whole organ tissue engineering program. Are you looking to fundamentally… more
- Takeda Pharmaceuticals (Boston, MA)
- …is true to the best of my knowledge. **Job Description** ** Associate Director , In Vivo Digital Portfolio & Data Stewardship** **About the Role** We ... are seeking an experienced ** Associate Director of In Vivo Digital Portfolio & ...science, operations, and technology-ensuring seamless integration of study workflows, regulatory compliance, and data interoperability across platforms.… more
- Guidehouse (Boston, MA)
- …**:** None **What You Will Do** **:** We are seeking an experienced Associate Director to join our growing AI and Data practice, with a dedicated focus on ... **Job Family** **:** Data Science Consulting **Travel Required** **:** Up to...excellence, decarbonization goals, grid modernization, and customer-centric innovation. The Associate Director will oversee cross-functional teams and… more
- Sumitomo Pharma (Boston, MA)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Commercial Data Management** . This high impact ... a strategic and technically skilled person to support our growing Commercial Data Management (CDM) function, serving as a key liaison between Commercial… more
- AbbVie (Waltham, MA)
- …with HEOR Strategy and other functions (eg, Clinical Development & Operations, Regulatory , Commercial). The Associate Director , Patient-Centered Outcomes ... key opinion leaders, research organizations, patient advocacy groups). The Associate Director represents HEOR at global regulatory and payer / HTA meetings… more
- Takeda Pharmaceuticals (Boston, MA)
- …the development of scientific communications strategy and deliverables, the ** Associate Director , Scientific Communications Lead, Hematology** proactively ... preferably in life sciences, and excellent project management skills. The Associate Director , Scientific Communications Lead, develops and implements strategic… more
- Sanofi Group (Framingham, MA)
- **Job Title:** GRA Device Lead ( Associate Director ) **Location** : Morristown, NJ/ Cambridge, MA/ Framingham, MA **About the Job** Are you ready to shape the ... skills 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
- 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 ... executes a labeling implementation plan to incorporate new scientific, safety and clinical data , as well as Health Authority responses / feedback into CCDS, USPI and… more
- Takeda Pharmaceuticals (Boston, MA)
- …application is true to the best of my knowledge. **Job Description** ** Associate Director , Digital Product Stewardship - Chemistry** **Position Summary** We ... are seeking a strategic and hands-on Associate Director to lead digital product stewardship...scientific, technical, and business domains. - Familiarity with FAIR data principles, regulatory compliance, and data… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- ** Associate Director , Small Molecule Analytical Development** + Lead and oversee phase appropriate method development and optimization for drug substance and ... drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines,… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Job Summary** **** The Associate Director , MSAT - Downstream provides specialized technical leadership and oversight for all downstream manufacturing ... process deviations or performance issues at CDMOs. + Analyze downstream process data (via CPV program, campaign summaries) to monitor performance, identify trends,… more
