- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , Global Regulatory Lead, GI & Inflammation ... where you will define, develop and lead global strategies to maximize global ...their regional counterparts. **How you will contribute:** + The Senior Director will be responsible for complex… more
- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + ... where you will oversee the development and execution of regulatory CMC development and registration strategies. RA ...Demonstrate high level of leadership and expert understanding of global RA CMC regulations and guidelines by… more
- Takeda Pharmaceuticals (Lexington, MA)
- …development plans. As part of the GRA CMC team, you will report to the Senior Director GRA CMC and work cross functionally across the business. **How you ... life-changing therapies to patients worldwide. Join Takeda as a Director GRA CMC where you will independently develop and...- technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. + When… more
- Takeda Pharmaceuticals (Boston, MA)
- …the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will ... order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , GRA CMC Pharmaceuticals Development Portfolio Lead where you will… more
- AbbVie (Waltham, MA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory ... maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and… more
- Takeda Pharmaceuticals (Boston, MA)
- …of company Subject Matter Experts across Global R&D (Pharmaceutical Sciences, CMC Regulatory Affairs & Devices), Global Manufacturing Supply and ... of my knowledge. **Job Description** Senior Technical Regulatory Advisor - Pharmaceuticals ( Senior /Executive Director...He/she must have a depth of experience in defining global Regulatory CMC strategy, superb collaboration skills,… more
- Novo Nordisk (Lexington, MA)
- …the therapeutic area, help develop PRO and biomarker strategies. Relationships Reports to: Senior Director of the Novel Modalities department Work with the ... you ready to make a difference? The Position The Senior International Medical Director serves as a...Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with… more
- ICON Clinical Research (Boston, MA)
- Senior Director , Design Control- Cambridge MA- Hybrid ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to ... fulfil our mission to advance and improve patients' lives. ** Senior Director , Design Control- Cambridge MA- Hybrid**...medical device regulatory process in collaboration with Regulatory Affairs and provide essential support during… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/ RA ) ... global and regional levels. + Ensure the appropriate global regulatory requirements, are considered as part...preferred. + Minimum of 15 year of directly related Regulatory Affairs experience; preferably a minimum of… more
- Takeda Pharmaceuticals (Lexington, MA)
- …of proposed promotional and disease state materials. + Collaborate with Regulatory Affairs , Medical, Legal, Commercial, and Compliance, execute and ... and compliance with regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the organization. Identify … more
- Pfizer (Cambridge, MA)
- **ROLE SUMMARY** The purpose of the Senior Director of Clinical Research role is to coordinate and lead the development of first in man (FIH), proof of mechanism ... and small molecule therapies in **programs focused on respiratory disease.** + The Senior Director of Clinical Research will be responsible for phase 2,… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …with Senior Management Cross-Functional Team (GLOC)** + In alignment with Head, Global Regulatory Affairs Marketed Products and Labeling, coordinates the ... patients with immunologic, hematologic, and other complex diseases. The Director , Global Labeling Strategy Lead is a...issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk… more
- Sanofi Group (Cambridge, MA)
- **Job title** : Senior Director , Marketing Operations NA GTMC **Location:** Bridgewater, NJ or Cambridge, MA (Hybrid role) **About the Job** We are an innovative ... up the decision making. We are seeking an experienced Senior Director of Marketing Operations to join...teams, including but not limited to Sales, Marketing, Medical Affairs , Legal, and Regulatory Affairs ,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …potential issues. **POSITION ACCOUNTABILITIES:** + Collaborate with colleagues in Regulatory Affairs , Medical, Legal, Commercial, and Compliance organizations ... true to the best of my knowledge. **Job Description** ** Senior Manager, US Medical Ad/Promo Regulatory Review**... regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the… more
- Regeneron Pharmaceuticals (Boston, MA)
- …leaders, advisory boards), internal stakeholders (eg, Research, Regeneron Genetics Center, Regulatory Affairs , Global Clinical Development, Precision ... The Senior Medical Director , Clinical Development will...key stakeholders , including pre-clinical research, Regeneron Genetics Center, regulatory affairs , clinical operations, and others. This… more
- Olympus Corporation of the Americas (Westborough, MA)
- …SaaS software solutions and AI algorithms will be highly desired. The Global Senior Product Manager will report to the Director of Global Product ... an entity other than @Olympus.com, it is likely not legitimate._ **Job Description** The Senior Manager, Global Product Marketing is a member of the Global… more
- Sanofi Group (Cambridge, MA)
- …protocol + TA Experts, senior CRDS, global clinical lead, GPHs and medical affairs + CROs + Regulatory affairs + Collaborates with other CRDs within ... **Job Title:** Clinical Research Director **Location:** Cambridge, MA **About the Job** Are...functions to ensure full strategic and operational alignment (pharmacovigilance, regulatory ) We are an innovative global … more
- Danaher Corporation (Boston, MA)
- …experience and drive improvements + Develop and implement sustainable processes + Enforces regulatory compliance as required by the QA/ RA department + Coordinate ... address the world's biggest health challenges. The Sr. Manager, Global Product Technical Support, Clinical IT for Beckman Coulter...GPTS for Automation and CIT and report to the director of the department. If you thrive in a… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Interacts with and influences other cross-functional departments (eg Development Operations, Regulatory Affairs , Medical Affairs , Data Science Institute, ... Description** **About the role:** Join Takeda as an Executive Medical Director , Pharmacovigilance in Gastrointestinal and Inflammation (GI2). You will oversee… more
- Sanofi Group (Cambridge, MA)
- …product + TA Experts, senior CRDS, global clinical lead, GPHs and medical affairs + CROs + Regulatory affairs + Collaborates with other CRDs within ... was possible. Ready to get started? The Clinical Research Director (CRD) is noted as the **primary clinical expert...tasks. + Interact with other CRDs in the project, Global Project Head, The PV Rep, Regulatory … more