Site Name USA Pennsylvania Upper Providence, GSK House, Switzerland Zug, USA Massachusetts Waltham, USA North Carolina Durham Posted Date May 17 2024 Purpose Ensure the development of appropriate Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital health asset(s) supporting across the GSK therapeutic

of Key Responsibilities Provides leadership and guidance to various stakeholders to ensure development and implementation of innovative global regulatory strategies across Alnylam's portfolio of combination/device products Provides technical, strategic and tactical regulatory guidance to matrixed product development teams Defines and optimizes global regulatory strategies

ImmunityBio, Inc. is a late stage immunotherapy company developing a broad pipeline of next generation therapies that drive immunogenic mechanisms for defeating cancer and infectious disease. The company's immunotherapy platform is designed to activate both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long term "immunologi

JOB DESCRIPTION Make your mark for patients. We're here because we want to build the future and transform patients' lives for the better. At UCB, our people are our experiences and achievements, our passion and drive. That's why we're looking for talented individuals with diverse backgrounds and experiences not just the best and brightest, but those who care about making

100% Remote. Option to go hybrid if close to site (ATO, AMA, ARI). EST preferred open to PST with minimum 4 hour overlap (8 6pm EST) IDEAL QUALIFICATIONS Bioprocessing/Pharmaceutical background preferred. Preference for candidates with previous experience in process development, clinical or commercial scale manufacturing with basic data science skills or an experience in

Execute a wide array of experiments in cellular and molecular biology. Perform cell culture routinely; establish and characterize innovative cell lines for disease modeling and pharmacology studies. Develop protocols for diverse assays, meticulously documenting and sharing research findings with colleagues. Actively contribute to the design and troubleshooting of experime

Biogen, Inc. seeks a Sr. Principal Biostatistician in Cambridge, MA to define statistical methodology, analyze data, report results, and contribute to the strategic planning and execution of the clinical development plan for the assigned project/program. Telecommuting permitted up to 50%. To apply, visit https //jobs.smartrecruiters.com/Biogen/743999979367739, and click &

Responsible for various aspects of quality assurance and quality control related to their functional area. Ensures that product within the plant is consistently manufactured in conformance with company Quality System requirements and all applicable regulatory requirements. Support troubleshooting and resolution of quality compliance issues. Communicates with Management fo

Responsible for the performing of tests and/or calibrations and evaluations or results related to GMP, ISO and non GMP materials and products as appropriate Responsible for troubleshooting basic issues with supervisory oversight Responsible for basic maintenance of equipment Sampling materials to be tested including, but not limited to, weekly water, RM and finished produ

The Field Reimbursement Manager (FRM) helps minimize access & reimbursement barriers for patients and providers to optimize access to Apellis' Ophthalmology portfolio. Within their geography, the FRM is responsible for addressing access barriers by strategically working with customers and accounts to solve the most complex patient access issues through all facets of the r

The Ragon Institute of MGH, MIT and Harvard at the Massachusetts General Hospital in Boston has an opening in the Balazs laboratory (https //balazslab.partners.org) for a highly motivated postdoctoral fellow to study the application of vectored antibody delivery as a means of treating HIV infection. This position requires an M.D. or Ph.D. with a background in infectious d

Scientist/Associate (Ph.D.) ID 2024 1582 Location US MA Natick Practice Polymer Science and Materials Chemistry Position Type Full time About Exponent Exponent is the only premium engineering and scientific consulting firm with the depth and breadth of expertise to solve our clients' most profoundly unique, unprecedented, and urgent challenges. We are committed to engagin

JOB DESCRIPTION Make your mark for patients. We're here because we want to build the future and transform patients' lives for the better. At UCB, our people are our experiences and achievements, our passion and drive. That's why we're looking for talented individuals with diverse backgrounds and experiences not just the best and brightest, but those who care about making

The Director, Clinical Pharmacology & Pharmacometrics,you will be responsible for the clinical pharmacology and pharmacometric deliverables for clinical development assets from phase I III and developing a clinical pharmacology plan and dose selection and prediction using mathematical and statistical models to study complex interactions between drug and patients, between

Lead the strategy and implementation of global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives. Act as the primary interface with multiple internal and external stakeholders, including partners. Works as Global Regulatory Leads (GRLs). Positively contributes to the global regulatory strategy for clinical and c