- Repligen (Waltham, MA)
- OverviewMake a global impact-join Repligen.We're united by a mission to inspire advances in bioprocessing as a preferred partner in the production of biologic drugs ... shared success-where every voice matters and every contribution drives progress. Join us!IT Manager , SOX & ITGC ComplianceWe are seeking an experienced IT Manager… more
- Sanofi (Cambridge, MA)
- …project under the leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to ... Job Title: Senior Clinical Research Director Location: Cambridge, MA or...Collaborate on key medical and clinical questions with the Global feasibility manager to prepare and interpret… more
- Sanofi (Waltham, MA)
- …compliance, Functional Planner, Project Manager , CROs, etc.) Under supervision of the senior manager of the TED team or Research lead, participates in ... and/or projects managers and under the supervision of the senior managers of the TED Team. He/She will assume...lead statistician and provides support, with minimal supervision from manager or TED Global Head, to the… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Senior Manager , Global Regulatory Labeling Strategy where you ... 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
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed ... lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing ... global regulatory strategies for CMC aspects of small molecule products during late-stage development and throughout the commercial lifecycle. This includes… more
- Chiesi (Boston, MA)
- …Responsibilities + Promotional Material/External Communications Responsibilities: + Work in the Global Rare Diseases, Regulatory Affairs Ad Promo function for ... others as needed. + Ensures appropriate implementation of Chiesi Global Rare Disease procedures for the regulatory ... guidance documents that impact US activities related to Regulatory activities. + Interact with senior management,… more
- Grant Thornton (Boston, MA)
- As a Regulatory & Practice Review Seasonal Senior Manager you'll support audit teams for regulatory inspection with all with the resources, environment, ... include: + Supporting audit teams that are selected for regulatory inspection + Communicating and interaction with the firm's...access to its member firms in more than 150 global markets. About the Team The team you're about… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- The Senior Manager , Global Product...of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory ... areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Job Summary** The Senior Manager of Global Quality Management (GQM) supports the execution of clinical quality activities to ensure compliance with Good ... or biotech industry. + Solid understanding of GCP, ICH guidelines, and global regulatory requirements. + Experience supporting inspection readiness and… more
- Western Digital (Boston, MA)
- …Together, we're the next BIG thing in data. **Job Description** **Role Overview** The Senior Manager , Logistics & Global Control Tower is a strategic ... to future-proof the organization. **Compliance & Sustainability** + Ensure audit readiness, regulatory compliance, and adherence to global standards in all… more
- Dentsply Sirona (Waltham, MA)
- …enhancing business relationships. + Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, ... advance patient care and deliver better and safer dentistry. Dentsply Sirona's global headquarters is located in Charlotte, North Carolina, USA. The company's shares… more
- Oracle (Boston, MA)
- …and stakeholder communication for smooth and timely rollouts. + **Support Global Compliance & Certification:** Collaborate with legal, regulatory , and ... Oracle Health Data Intelligence (HDI) is hiring a Principal Technical Program Manager - Operations to lead key strategic and operational initiatives across the… more
- Takeda Pharmaceuticals (Boston, MA)
- …company that will inspire you and empower you to shine? Join us as a Senior Director, Global Program Leader - Oncology, Solid Tumors in our Cambridge office. ... and strong enterprise leaders + Committed to simultaneously driving regulatory approval as well as launch and global...on the sub-team objectives. + Accountable with the responsible Global Program Manager for activities operating budgets… more
- ConvaTec (Lexington, MA)
- …100 Index (LSE:CTEC). To learn more please visit http://www.convatecgroup.com **Position Overview:** The Senior Manager plays a key role to the success of ... Convatec's clinical trials. The Senior Manager , Clinical Trials Management oversees the...(Study Management, Site Management, Data Management / Data Analytics), Global Head of Clinical Operations, R&D, Regulatory … more
- Sanofi Group (Cambridge, MA)
- **Job title:** Senior Manager of Digital Alliances **Location:** Cambridge, MA **About the job:** This position supports a portfolio of digital alliances, ... consistent with strategic priorities and contractual obligations. Additionally, you'll support the Senior Director and DSP team in negotiating new deals and amending… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- The Senior Manager , External Engagement Strategic Planning will play a critical role in shaping and executing strategic initiatives that enhance the impact of ... for scientific exchange and stakeholder engagement, while ensuring alignment with global and US medical strategies and business objectives. **Job Description** **Key… more
- FranklinCovey (Boston, MA)
- …and post-secondary schools and institutions. To learn more, visit franklincovey.com **Title:** Senior Internal Audit Manager **Payroll Title:** Sr Internal Audit ... offices in over 160 countries and territories. With more than 2,000 global associates, FranklinCovey transforms organizations by partnering with clients to build… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- The Senior Manager , Centers of Excellence (CoEs) is responsible for establishing, leading, and optimizing one or more prioritized CoEs within the Global ... or business excellence roles. + Solid understanding of GxP principles and global regulatory expectations. + Experience supporting audit or inspection readiness… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a ... Senior Manager of Statistics, you will provide...and biomarker assay development and validation. + Collaborate with Global Manufacturing, Regulatory Affairs, and Global… more
