Are you an experienced Regulatory Affairs leader with a passion for medical devices? Are you looking for a motivated and diverse department to empower, guide and mentor Applied...
Work with country or global teams to plan and implement Phase IV GMA-sponsored clinical trials, interventional or non-interventional. This includes all aspects of study management...
Contribute to study protocol development including study concept, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate,...
Generate impactful biochemical, biophysical, and structural biology data with human relevance to support our small molecule- and genetic medicine projects. Explore target...
You will be responsible for new product implementation (NPI) into a manufacturing facility, and for support of drug substance manufacturing processes during commercial...
You will support the professional development of their reports, ensure that robust Medical Affairs plans are developed and executed on time, on budget, and to strategy, and foster...
Develops a strategy for external manufacturing of Teva’s products and manage its implementation, in collaboration with TGO leadership and commercial units. Establishes and...
This role serves as a close business partner and facilitator of regulatory activities and is expected to contribute to developing sound regulatory strategies globally. The role...
Oversee Santhera's global Pharmacovigilance (PV) system, ensuring compliance with regulations and managing PV vendors and activities; Ensure Santhera meets its obligations as a...
This role is pivotal in driving biomarker strategies, early clinical development plans, and providing scientific expertise and strategic guidance. The successful candidate will...
Lead and provide technical expertise in the planning and execution of IVD assay development projects, acting as a knowledge expert for quantitative PCR (qPCR) diagnostic systems...
You will provide leadership for all Small Molecule QC laboratories related to Lonza’s Visp site. You will ensure adequate resources (staff, laboratory and instrumentation) to...
Responsible for providing operational support for the planning, management, support and execution of regulatory activities for PTC drug products (clinical and commercial) within...
Leading the Clinical Pharmacology program and strategy of assigned programs by defining and implementing the Clinical Pharmacology Plan of NCE/NBE to support the registration...
Designs and delivers innovative & collaborative medical affairs projects, has a significant role in developing and driving the Medical Affairs Plan, operates as a medical reviewer...
As part of our PV team you will be working collaboratively with the Global Product Safety Science Lead (GPSSL) for assigned product(s) as well as with other PV functions, to ensure...
Responsible for the planning and organization of formulation and process development of various modalities - with a focus on parenteral formulation containing nanoparticular...
Provides Quality oversight for Bicycle’s development programs, ensuring compliance with applicable ICH GCP and GLP standards and global regulations. As an integral member of the...
Lead (Co-lead) the study teams to develop a cross-functional, integrated study implementation plan including creation of initial study budget, study kick-off and team meetings....
This is a leadership role that requires a scientific visionary with deep expertise in oncology, immunology, and data-driven target discovery, coupled with strong team management...