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

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 &

The successful candidate will have a strong interest in laboratory work and will be key to driving the development of safe and scalable chemistry with an emphasis on mutagenic impurity formation and control. This role will have accountability for creating and developing a synthetic route to deliver active pharmaceutical ingredients (APIs) within a specification range fit

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

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

The Senior Manager, Quality Analytical Microbiology is an advanced technical resource in the principles and application of microbiology quality assurance and compliance. The Senior Manager, Quality Analytical Microbiology coordinates or executes activities on multiple complex projects and takes a role in the design and execution of new projects. Key Duties and Responsibil

The Clinical Supply Planning Manager is responsible for planning, forecasting and allocation of devices, constituents and process aids to support Vertex clinical studies. This role delivers on independent activities and acts as the primary Supply Chain contact on working teams and with key contract manufacturing/logistics suppliers. Key Duties and Responsibilities Ownersh

Supports the development of upstream production processes for cell therapy projects Develops protocols and technologies in support of product development from clinical to commercial scale Applies statistical principals such as DOE/QBD to process development, establish process parameters, and contribute to CMC sections of regulatory filings Supports technology transfer to

Key contributor within the Government Pricing Team, with demonstrable knowledge and experience in government pricing calculations and reporting requirements including Medicaid, Medicare, 340B and FSS. Works with cross functional business partners on forecast and accrual estimates, pricing and G2N modeling, and analysis for new and evolving pricing legislation. Provides ma

As a Biostatistics Associate Director at Vertex, you will be at the forefront of cutting edge medical research, analyzing complex data to unravel crucial insights that may lead to medical breakthroughs. You will collaborate with interdisciplinary teams, applying novel statistical methodologies to solve real world challenges, ultimately contributing to the development of l

The Director, GCP Compliance is responsible for the escalation and management and compliance activities in support Quality Issues Management and other activities within RDQA. This role will act as a lead for GCP related events and escalation of these events. This individual will work closely with Quality Leads, Study team members, and other pillars in the Quality organiza

The Senior Director Publications is responsible for contributing to the co creation and strategic development of medical and scientific publications included in a global disease publication plan. This role will provide leadership and expertise in publications creation and execution. This position has a hybrid schedule which allows for 2 days per week working remotely and

The successful candidate will possess a deep knowledge of process chemistry skills for the development of synthetic routes, with early and late phase development experience and delivering drug substance under tight timelines. They will have a strong interest in laboratory work and will be key to driving the development of safe and scalable chemistry. They will spearhead t

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