- Takeda Pharmaceuticals (Boston, MA)
- …+ Manufacturing Sciences + Global Manufacturing Supply, Global Quality and Global Regulatory Affairs . + SME for Takeda drug product manufacturing organization ... and the life cycle management of existing products. You will lead regulatory interactions, including the preparation of Chemistry, Manufacturing, and Controls (CMC)… more
- Fallon Health (Worcester, MA)
- …and correspondence with internal business owners, Compliance, IT Security, MassHealth, SCO, Regulatory Affairs and legal counsel as appropriate. + Work ... + Ongoing vendor management to ensure all contract terms and conditions including regulatory and compliance related requirements are being met. + Perform all aspects… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …**Global Collaboration & Stakeholder Engagement** + Partner with stakeholders across Regulatory Affairs , Clinical, Manufacturing, Compliance, and IT to align ... excellence roles. + Solid understanding of GxP principles and global regulatory expectations. + Experience supporting audit or inspection readiness programs. +… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …clinical biomarker assay development and validation. + Collaborate with Global Manufacturing, Regulatory Affairs , and Global Quality to explore methods and ... issues to management as appropriate in a timely manner. + Respond to regulatory questions that are statistical in nature. + Increase the external recognition of… more
- Commonwealth Care Alliance (Boston, MA)
- …+ Coordinate with other CCA departments, including Clinical Management, Member Services, Regulatory Affairs , Claims and Outreach and Marketing, to resolve ... service recovery; Program benefits; Clinical initiatives; Referral and authorization; Regulatory compliance; Billing and payments; Complaints and appeals; Policies… more
- Medtronic (Boston, MA)
- …Collaborate cross-functionally with software development, systems engineering, quality assurance, and regulatory affairs teams to ensure seamless integration and ... verification of software components. + Participate in design reviews, risk assessments, and project planning to provide early feedback on software design and testability. + Contribute to the strategic planning and continuous improvement of the overall software… more
- Cole-Parmer (Franklin, MA)
- …product line development in collaboration with Research & Development, Operations, Regulatory Affairs and Commercial teams. Implement appropriate programs to ... either internally develop, contract manufacture, license or source the appropriate products with the goal of driving revenue & profitability growth of the category portfolio. + Drive product area efforts and coordinate with Corporate Development (M&A) and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …the US Compliance Committee. + Working collaboratively across functions, including Compliance, Regulatory and Medical Affairs , to support a policy, training and ... work very closely with your Oncology Commercial and Medical Affairs clients. As a member of the extended Takeda...Providing strategic advice regarding the assessment and mitigation of regulatory , AKS and privacy risks that can arise in… more
- Pfizer (Cambridge, MA)
- … stakeholders. + **Cross-Functional Partnership:** Work cross-functionally with Medical Affairs , Regulatory , Safety, Operations, and Business Development and ... I&I drug development, protocol writing, study conduct, data analysis, and regulatory submissions. + Strong leadership and interpersonal skills, with demonstrated… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …lead a cross-functional team, working closely with market access, sales, medical affairs , regulatory , and commercial excellence to align on strategic priorities ... pull-through execution. + **Cross-Functional Leadership:** Collaborate closely with medical, regulatory , commercial operations, and finance teams to ensure cohesive… more