- Cardinal Health (Boston, MA)
- …hours. We also provide customers the support they need in regulatory compliance, reimbursement, continuing education, information management and other crucial areas, ... of medical affairs professionals who report to the Sr Director of Regulatory & Medical Affairs. **Responsibilities:** + Collaborate across multiple functions and… more
- Cytel (Cambridge, MA)
- …model-informed drug development), to provide strategic advice to define optimal regulatory , clinical and/or market access pathways and promote faster patient access ... recognized thought leader and strategic advisor in the areas of optimal regulatory , clinical development and/or market access pathways and quantitative strategies to… more
- Astrix Technology (Boston, MA)
- …Collaboration: Work closely with internal teams such as Clinical Development, Regulatory Affairs, and Commercial to provide medical insights that inform strategic ... decisions. + Compliance and Reporting: Ensure all activities comply with regulatory standards and company policies, and accurately document interactions and insights… more
- Cambrex High Point (Waltham, MA)
- …reports, batch records, validation protocols, CMC documentation (eg, Module 3), and regulatory filings (IND, NDA). + Collaborate cross-functionally with QA, QC, ... regulatory , and supply chain to ensure technical alignment and...therapeutic development Education, Experience & Licensing Requirements Education: + PhD . in Organic Chemistry, Chemical Engineering, Pharmaceutical Sciences, or… more
- Sanofi Group (Waltham, MA)
- …at extended clinical team meetings and may attend external meetings with regulatory agencies and key opinion leaders. We are an innovative global healthcare ... (CROs) + Links with other internal stakeholders (such as Regulatory Managers or Product Safety Officers in Pharmacovigilance for...and publications of statistical topics **About You** + Earned PhD in statistics or related discipline with 2+ years… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …analytical development, drug product development, manufacturing, quality assurance, and regulatory affairs, to develop and implement effective process engineering ... or business processes. + Responsible for authoring relevant sections of regulatory documents, validation plans, development reports, process flow diagrams (PFDs),… more
- Lilly (Boston, MA)
- …to novel genetic medicine therapeutic modalities + Understanding of pharmaceutical regulatory guidance and expectations + Agile interrogation of diverse data (eg, ... interdisciplinary teams + Lead the preparation of ADME portions of regulatory communications and documents to support clinical development, new drug applications,… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …for assigned areas. Knowledge and strong competency with the US healthcare system and regulatory landscape is required for this role. + Stay abreast of the latest ... and real-world evidence, US and global commercial teams, market access, and regulatory affairs, to ensure integrated global strategies and cohesive medical affairs… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global regulatory standards. + Establish and oversee robust Continued Process Verification ... appropriate. + Collaborate with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs, and Operations to align strategies and optimize product… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …update appropriate SOPs and ensure compliance with relevant industry trends, regulatory changes, and emerging scientific advancements and standards + Scientific ... responses. **Required Qualifications:** + Advanced degree in life sciences (PharmD, MD, PhD ) or equivalent. + 15+ years of experience in medical affairs leadership… more