- Merck (Boston, MA)
- …+ Coordinate regional regulatory strategy and submissions through collaboration with Regulatory Affairs Europe (RAE) and local affiliate teams. + Provide ... + Local registration study protocols for secondary markets + Represent Global Regulatory Affairs on internal committees (eg, DRC, ADT/PDT, EDT, LEAD) to provide… more
- ConvaTec (Lexington, MA)
- …project work + **Scientific & Technical Labs** to execute testing, as required. + ** Regulatory Affairs ** to collaborate on requirements as well as gain early ... Applied Research organization within the Biomedical Sciences team, the Principle Scientist - Biointerfaces and Regenerative Engineering is responsible for leading a… more
- Merck (Boston, MA)
- …scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations) + ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- Takeda Pharmaceuticals (Boston, MA)
- …assessment document + Engages with partner global functions (eg Clinical Science, Med Affairs , Regulatory Affairs , Biostats) to ensure alignment of global ... to shine? Join us as a PV Risk Management Scientist /Associate Director. At Takeda, we are transforming the pharmaceutical...we do. As an Associate Director/ PV Risk Management Scientist , being part of our Risk Management and Benefit… more
- Takeda Pharmaceuticals (Boston, MA)
- …through independent research and collaboration with subject matter experts in medical affairs , regulatory , and clinical operations; ensure high quality delivery ... following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Data Scientist **POSITION DESCRIPTION** : Takeda Development Center Americas, Inc. is… more
- AbbVie (Worcester, MA)
- …guidelines. + Experience collaborating with the process development, quality control, and regulatory affairs teams to align analytical strategies with project ... guidelines, ensuring methods are suitable for late-phase development and regulatory submissions. + Experience using automation to standardize high-throughput… more
- Pfizer (Cambridge, MA)
- …design, conduct, and analysis. They work closely with other functions such as regulatory affairs , pharmacovigilance, biostatistics, and medical affairs to ... Lead and contribute to development and maintenance of clinical trial and regulatory documents, in collaboration with Clinical Scientist and the cross-functional… more
- Sanofi Group (Cambridge, MA)
- …The GPH will be delegated such responsibilities as interaction with regulatory /health authorities (HA), approval of documents and product label, as appropriate. ... Brand Team (GBT) + Defines global project plans and regulatory strategy together with the GPT members; leads the...close collaboration with Market Access, Global Commercial and Medical Affairs , as Active member of GPT. + Contributor to… more
- Sumitomo Pharma (Boston, MA)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs , Data Management and Biostatistics is essential. ... highly motivated, and experienced individual for the position of Pharmacovigilance Scientist to perform PV activities for assigned programs(s). Ability to work… more
- Amgen (Cambridge, MA)
- …closely with cross-functional teams, including R&D, manufacturing, quality assurance, and regulatory affairs , to ensure alignment and successful design transfer. ... deep understanding of medical device design, manufacturing processes, and regulatory requirements. Key Responsibilities: + **Design Transfer Execution:** Develop and… more