The GMP Operational Associate Director is recognized as an expert internally in the principles and application of quality assurance and compliance. The GMP Operational Associate Director will provide QA support of manufacturing operations, oversee sterilization processes and microbiological testing, and serve as a Product Quality Lead for the activities supporting Cell &

Key contributor within the Government Pricing Team, with demonstrable knowledge and experience in government pricing calculations and reporting including Medicaid and Medicare programs. Manages reporting of monthly and quarterly pricing obligations to CMS, including source data reconciliation, calculation, documentation, and pricing submission. Collaborates with cross fun

The Senior Manager will manage a team within VCGT Device Analytical Development that is focused on commercial device and combination product development. The team will work closely with the Commercial Process Development team and Contract Manufacturers to develop and transfer methods for use in commercial manufacturing. This role is critical to bringing a transformative c

The Senior Director, Regulatory Strategy, is a regulatory leader with expert technical and tactical experience in regulatory strategy for the assigned global or regional position and will be responsible for overseeing the development and implementation of advanced global regulatory strategies for development programs (1) in emerging disease areas, (2) for additional devel

This role will report to the senior manager of Product Development and focus on the design and transfer of implantable cell encapsulation devices for delivering proprietary cells. The successful candidate will join the Process Engineering Team and work closely with Research and Development, Device Quality Control, Device Quality Assurance, Regulatory Affairs, and Manufact

Develop engagement strategy and account plans to ensure success with target IDNs, GPOs and GPO aggregate accounts Engage with IDN, GPO and GPO aggregate account leadership, formulary decision makers, and population health stakeholders to ensure timely access and contracting, support product uptake, drive systemic change, and pursue creative partnerships, as appropriate Co

Oversee material requirements and lead the device raw material planning process for the providence, RI site for BOM and non BOM materials. Partner with CMC, Procurement and Strategic Sourcing to ensure supply and solve supplier and materials related issues. Manage direct and indirect materials for manufacturing activities, as well as materials for packaging/labeling and s

Define, execute, and adapt the vision and strategy for the Global Research ELN at Vertex across geographies, modalities, and scientific disciplines Work with vendors and internal business partners to produce a product roadmap and rollout strategy Serve as Technical SME for enhancements, software upgrades, implementations, and integration projects providing product experti

Develop engagement strategy and account plans to ensure success with target IDNs, GPOs and GPO aggregate accounts Engage with IDN, GPO and GPO aggregate account leadership, formulary decision makers, and population health stakeholders to ensure timely access and contracting, support product uptake, drive systemic change, and pursue creative partnerships, as appropriate Co

Develop engagement strategy and account plans to ensure success with target IDNs, GPOs and GPO aggregate accounts Engage with IDN, GPO and GPO aggregate account leadership, formulary decision makers, and population health stakeholders to ensure timely access and contracting, support product uptake, drive systemic change, and pursue creative partnerships, as appropriate Co

The Clinical Development Medical Director will serve as the Medical Lead for Vertex clinical trials in Vertex' Nephrology programs, working with cross functional multidisciplinary study teams on clinical trial strategy, design and execution and serving as the Medical Monitor responsible for monitoring the safety of enrolled subjects on assigned trials.The incumbent will w

Establishes meaningful and professional relationships within key accounts across multiple layers of the hospital system (key hospital medical and administrative staff, pharmacies, formulary decision makers and KTLs) Develops and maintains expertise on the product's clinical attributes and patient unmet need and educates healthcare professionals on product use in appropria

Establishes meaningful and professional relationships within key accounts across multiple layers of the hospital system (key hospital medical and administrative staff, pharmacies, formulary decision makers and KTLs) Develops and maintains expertise on the product's clinical attributes and patient unmet need and educates healthcare professionals on product use in appropria

Our department is a highly collaborative collection of groups consisting of biology, engineering, modeling and simulation, and prototyping, centered around developing cutting edge transformative cell and gene delivery platforms. In this position the intern will support routine analytical testing and material characterization, in addition to assisting with fixture design,

Establishes meaningful and professional relationships within key accounts across multiple layers of the hospital system (key hospital medical and administrative staff, pharmacies, formulary decision makers and KTLs) Develops and maintains expertise on the product's clinical attributes and patient unmet need and educates healthcare professionals on product use in appropria