- Takeda Pharmaceuticals (Boston, MA)
- …inspire you and empower you to shine? Join us as a Executive Medical Director , Oncology Clinical Sciences in our Cambridge office. At Takeda, we are transforming the ... development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency… more
- Takeda Pharmaceuticals (Boston, MA)
- …best of my knowledge. **Job Description** **About the role:** Associate Director , Clinical Program Quality Investigations is responsible for ensuring the compliance ... for clinical deviation management, and Serious Breaches investigation and reporting to regulatory agencies. + Act as strategic partner to Clinical Program Quality… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …+ Leads flagships medical programs as defined by the Global Medical Affairs (GMA) Strategy Team and sub-teams + Leads GMA-driven evidence generation, taking ... into consideration the medical, scientific, regulatory and commercial considerations + Supports multi-disciplinary matrix teams...as a study Medical Lead for the GMA Medical Affairs Company Sponsored / Collaborative studies + Manages complex… more
- Commonwealth Care Alliance (Boston, MA)
- …field preferred. Required Experience (must have): * 5+ years in healthcare compliance, regulatory affairs , or claims audit. * Experience working with TPA ... will not be considered at this time._** Position Summary: Reporting to the Director , Claims Operations & Quality Assurance, the Regulatory Compliance & Audits… more
- J&J Family of Companies (Cambridge, MA)
- …and external human data resources. + Partner with Clinical Development, Global Regulatory Affairs , Data Science, Patient Reported Outcomes, Statistics and other ... while championing patients every step of the way. We are searching for a ** Director , Computational Multiomics, Neuroscience,** to be located at one of our offices in… more
- Takeda Pharmaceuticals (Boston, MA)
- …functions (eg project management, clinical monitoring, data management process, regulatory affairs , pharmacovigilance, etc.) to enable meaningful dialogue ... company to inspire you and empower you to shine? Join us as the Director , Supplier Relationship Management (FSP) based in Cambridge, MA reporting to the Head… more
- AbbVie (Cambridge, MA)
- …one aspect of Drug Development (eg, pre-clinical research, clinical development, Regulatory Affairs , Chemistry Manufacturing and Controls (CMC)). + Experience ... an in-depth understanding of the science behind each of these opportunities. The Associate Director , Search & Evaluation will be a key member of the Specialty and… more
- Takeda Pharmaceuticals (Boston, MA)
- …processes and training and ensure alignment with global processes and regulatory requirements and expectations. + Drive the implementation and change management ... enable execution of CPMQ activities, ensuring alignment with global processes and regulatory requirements. + Create and deliver training solutions to support the… more
- Takeda Pharmaceuticals (Boston, MA)
- …analytical/organic/physical chemistry, process engineering, pharmaceutics, quality assurance and/or regulatory affairs . Advanced understanding in DMPK, ... Guidelines, other pertinent national regulations, compendial requirements and communicating with regulatory agencies. + Must have experience in global regulatory … more
- AbbVie (Worcester, MA)
- …product development, Quality Systems, Product QA, Quality Control, Information Systems & Regulatory Affairs . Of experience required, must have at least 3 ... within the biologics industry; + using Quality policies, cGMP & other regulatory requirements; & + managing QC clinical & commercial projects by collaborating… more