- Genentech (Boston, MA)
- …Medical Director will have strong collaboration with cross-functional teams, including clinical research, regulatory affairs , and product development, ... position would also require a strong understanding of cardiovascular diseases, clinical trial protocols, regulatory requirements, and possibly interactions with… more
- Sanofi Group (Waltham, MA)
- …stage. The incumbent is accountable for all statistical aspects of clinical development/medical affairs plans, studies and submissions activities (when ... technical success. + Contribute with project team members (ie: clinical , pharmacovigilance, regulatory , ) to gain Health...packages are delivered and comply with Health Authorities (eg: FDA , PMDA, CDE, KFDA,..) expectations Act as + Represent… more
- Astrix Technology (Boston, MA)
- …, EMA, and ICH guidelines. + Collaborate with cross-functional teams, including preclinical, clinical operations, and regulatory affairs , to integrate and ... for RNA-targeted therapeutic programs worldwide. + Ensure adherence to international clinical development and regulatory standards. **Qualifications:** + MD or… more
- Catalent Pharma Solutions (Chelsea, MA)
- …of final products. **EDUCATION AND** **EXPERIENCE** : Requires a Bachelor's degree in Drug Regulatory Affairs and 4 years of experience in job offered or 4 ... Perform various quality assurance checks during all manufacturing processes; Assess regulatory and quality risks in manufacturing activities and processes according… more
- Takeda Pharmaceuticals (Boston, MA)
- …talent with the ability to make tough talent decisions. + Deep expertise in ** Regulatory Affairs , Clinical Development, and R&D technology ecosystems** (eg, ... role owns a portfolio of platforms and products-such as Regulatory Information Management (RIM), Clinical Operational, ... requirements (21 CFR Part 11, GAMP 5, GDPR, FDA /EMA guidelines). + Manage and mentor a team of… more
- Sumitomo Pharma (Boston, MA)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs , Data Management and Biostatistics is essential. **Job ... as required. + Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician,… more
- Takeda Pharmaceuticals (Boston, MA)
- …experience in GCP Quality/Compliance. + Advanced knowledge of pharmaceutical development, medical affairs and GCP/GVP regulations including FDA , EU, MHRA, PMDA ... + Experience must include successful development and implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections,… more
- Baystate Health (Springfield, MA)
- …in matters of corporate law, business transactions, financing, medical staff, regulatory compliance, health law, legal aspects of drug diversion detection, ... assists in overseeing outside counsel. May be responsible for managing legal affairs within a particular area of law. Shares law department management… more
- Takeda Pharmaceuticals (Cambridge, MA)
- … and biomarker assay development and validation. + Collaborate with Global Manufacturing, Regulatory Affairs , and Global Quality to explore methods and implement ... access to modern medicines. This role will also support clinical /biomarker assay development and validation. For more information on...as appropriate in a timely manner. + Respond to regulatory questions that are statistical in nature. + Increase… more
- Pfizer (Cambridge, MA)
- …with key cross functional partners including but not limited to Medical, Clinical , Commercial Diagnostics, Global Marketing, Regulatory , Market Access and ... + Lead external partnerships in collaboration with OPSA and Public Affairs + Build and maintain external partnerships with labs, advocacy, professional… more