- Sanofi Group (Waltham, MA)
- **Job Title:** CMC Project Manager **Location:** Framingham, MA, Waltham, MA **About the Job** Are you ready to shape the future of medicine? The race is on ... their families. Your skills could be critical in helping our teams accelerate progress. The CMC Project Manager is a key contributor of the CMC … more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …requirements for CMC and GMP related submissions and inquiries. + Represents CMC RA in project team meetings and provides regulatory guidance and perspective ... Provide CMC regulatory strategy input and expertise in the...marketed biologic and small molecule drug products to assigned project teams, to ensure Otsuka's products are developed/maintained in… more
- Cardinal Health (Boston, MA)
- …systems and contributes to reports and presentations for clients. May serve as a project manager for smaller projects and ensure that team members achieve ... to Cardinal Health_** The _Scientist I, Chemistry, Manufacturing, and Control ( CMC )_ ensures efficient and quality production of product submission dossiers for… more
- Shuvel Digital (Boston, MA)
- …Certifications + IT and Technology-Specific Certifications + Certified Information Systems Project Manager (CISPM) + ITIL Certification (Information Technology ... of program financial performance. Develop and deliver required contract, departmental, project and/or financial reports. Program Planning and Strategy + Project… more
- Sumitomo Pharma (Boston, MA)
- …seeking a dynamic, highly motivated, and experienced individual for the position of **Senior Manager , Regulatory Affairs** . The Senior Manager is part of the ... (HA) information requests. This position represents GRA on less complex project related meetings and provides regulatory input as appropriate. This position… more
- Fresenius Medical Center (Waltham, MA)
- The internal Job Title is called **Global Product Center Manager (m/f/d) - Sterile Fluids (Medicinal Products).** **Main Responsibilities:** + Support as regulatory ... expert development and new registration projects (Medicinal Products) + Project management for the implementation of projects to comply with regulatory requirements… more
- Takeda Pharmaceuticals (Boston, MA)
- …integral part of the Pharmaceutical Sciences Sustainability and Technology (PSST) Sustainable CMC & Innovation team within PharmSci, In Silico First Program and ... Strategy Manager is crucial to operational efficiency & technical direction...and across the organization. + Identify, mitigate, & communicate project or program risks to relevant stakeholders. This person… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works ... the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. - Works… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- The Sr. Manager , CTA Regulatory Strategy is responsible for providing critical support in developing global regulatory strategy, planning, and execution of global ... of the global regulatory team (GRL, Clinical Transparency, Medical Writing, GRA- CMC , etc.) to contribute to global regulatory plans, address global regulatory… more
- Takeda Pharmaceuticals (Lexington, MA)
- …progress; manage individual study budgets and communicates status to appropriate TA project manager ; and execute communication and change management plans. + ... CMC , Marketing). + Minimum of 5 years' experience as a clinical project /program manager leading complex pharmaceutical, academic or hospital system clinical… more
- Takeda Pharmaceuticals (Boston, MA)
- …role is defined by Takedas' values of Patient-Trust-Reputation-Business. In addition to project specific responsibilities, the ED GPL may be called upon to represent ... through the functional sub-teams leaders and their teams all project deliverables achieve defined project scope &...the sub-team objectives. + Accountable with the Global Program Manager for operating budgets within the global program; leads… more
- Takeda Pharmaceuticals (Boston, MA)
- …The GPL ensures through the functional sub-teams leaders and their teams all project deliverables achieve defined project scope & objectives, budget and ... on the sub-team objectives. + Accountable with the responsible Global Program Manager for activities operating budgets within the global program; leads budget… more