- Parexel (Boston, MA)
- …We are currently seeking a dedicated and detail-oriented **Regulatory CMC Project Manager ** to join a growing, dedicated client partnership and play a pivotal ... teams to prepare comprehensive tables of contents for CMC/Module 3 submission deliverables. This includes managing start/end timelines, identifying ownership, and… more
- Parexel (Boston, MA)
- Join us as a ** Global Labeling Operations Manager ** , where you'll work alongside a large, dedicated client team to drive impactful labeling operations across ... global markets. In this role, you will oversee end-to-end...and prepare annual labeling reports. - Review and update submission content plans; prepare change control documentation for CCDS-driven… more
- Parexel (Boston, MA)
- …authority on safety profiles for assigned products, ensuring compliance with global regulations while providing critical medical insights. You'll collaborate with ... labeling documents, data handling conventions, client's guidelines and procedures, and global drug safety regulations and guidelines + Maintaining an awareness of… more
- Integra LifeSciences (Braintree, MA)
- …and set new standards of care. **SUMMARY DESCRIPTION** The Associate Manager , Quality Compliance supports the development, maintenance, and continuous improvement of ... in ensuring ongoing regulatory compliance across site operations. The Associate Manager will also support external audit readiness and execution, including… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Software as a Medical Device. + Demonstrated leadership in managing the global submission process for regulatory approvals across multiple markets. + ... scalable processes to support Olympus' digital transformation journey. This position supports the Global Senior Manager to plan and direct the OSTA Core… more
- Integra LifeSciences (Mansfield, MA)
- …This position is under the direct supervision of the Quality Compliance Manager . Works independently under general supervision, reviewed at project milestone and/or ... knowledge of FDA Quality Systems Regulations, GMP, ISO 13485 and other global regulations and standards. + Previous experience in high volume manufacturing… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Global Submission Manager **Location:** Morristown, NJ **About the Job** The Global Submission Manager applies global ... and has appropriate insight into the development plans for the products. The Global Submission Manager is responsible for the operational submission … more
- Chiesi (Boston, MA)
- …Who we are looking for Purpose Responsible for the regulatory review and submission of advertising and promotional materials for multiple Chiesi Global Rare ... including generation of new labeling and changes to existing labeling, and submission of labeling information to regulatory authorities in the United States and… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as Senior Manager , Global Regulatory Labeling Strategy where you will be responsible ... to obtain labeling approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight Committee - GLOC) and facilitates discussions to ensure… 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 ... manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the GPL on the sub-team objectives. + Accountable with the responsible Global Program Manager for activities operating budgets within the global ... POM/POC in novel mechanisms with less-defined regulatory pathways through large-scale Phase III/ submission projects and global launch projects. + Links GPT… more
- PSI Services (Boston, MA)
- **Description** **Title:** Bid Manager **Location:** Remote-US **Salary:** Up to $100K annually + bonus **About PSI** Join Us at PSI - Where You Belong, Grow, and ... aligns with your expectations. **About the Role** The Bid Manager is the engine behind the proposal process -...and ensuring every element stays aligned from kickoff through submission . This role owns the proposal timeline, manages resources… more
- Educational Testing Service (Boston, MA)
- **About ETS:** ETS is a global education and talent solutions organization enabling lifelong learners worldwide to be future-ready. For more than 75 years, we've ... countries and territories. Through strategic acquisitions, we've expanded our global capabilities: PSI strengthens our workforce assessment solutions, while Edusoft,… more
- Sanofi Group (Cambridge, MA)
- …and life cycle management) under their responsibility. The PPM provides proactive support to the Global Project Head, Global Project Manager and Global ... **Job Title:** Project Planning Manager **Location:** Cambridge, MA **About the Job** Join...into possible for millions. To support sustainable growth Sanofi Global Development ambition is to be the industry-leading Development… more
- AON (Boston, MA)
- …Take a look at Aon! Our commercial risk team in Boston is looking for an Account Manager II. This is a hybrid role based out of our Boston, MA office. Aon is in ... best self at Aon. Furthermore, all colleagues enjoy two " Global Wellbeing Days" each year, encouraging you to take...will not be compensated in any way for your submission of a candidate, even if Aon hires that… more
- Sanofi Group (Cambridge, MA)
- …landscape changes that enhance ability to optimize from early Research to our global submission strategies with key partners + Regularly provide project ... **Job Title:** Research Project Planning Manager and AI Planning Lead **Location:** Morristown, NJ Cambridge, MA **About the Job** Join the engine of Sanofi's… more
- Charles River Laboratories (Wilmington, MA)
- …you can feel passionate about. **Job Summary** We are seeking a Marketing Manager to join our Discovery and Safety Assessment marketing team, focusing on supporting ... development and safety assessment. Your work will help shape strategies that impact global health and industry standards. This position will work remote from home… more
- Proficio, Inc. (Boston, MA)
- …retail and other industries. Take a video tour (https://youtu.be/s6zP\_TFwTt4) of our global network of 24/7 Security Operations Centers (SOCs). Proficio(R) has been ... 2017. MSSP Alert ranks Proficio among the top 250 global Managed Security Services Providers (MSSPs). We have a...and drive their success. SUMMARY The Senior Regional Sales Manager is responsible for prospecting, developing, and closing new… more
- HUB International (Milford, MA)
- …team at HUB International, you become part of the largest privately owned global insurance broker, providing a broad array of property, casualty, risk management, ... tailored to their needs. We believe in empowering our employees. As a global firm, we offer employees resources in both technology and industry expertise, but… more
- HUB International (Milford, MA)
- …team at HUB International, you become part of the largest privately owned global insurance broker, providing a broad array of property, casualty, risk management, ... tailored to their needs. We believe in empowering our employees. As a global firm, we offer employees resources in both technology and industry expertise, but… more
