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Responsible for assisting with defining compound/program medical strategies and for leading select medical affairs projects within a specific compoundor indication...
Developing and implementing clinical and pre-clinical regulatory strategies for all development stages; Coordinating regulatory submissions, including Scientific Advice, MAAs...
The primary role of Medical Director is to provide medical oversight for clinical trials by serving as Medical Monitor for studies conducted by IQVIA Biotech Clinical on behalf of...
Manage all aspects of the conduct of assigned Global and/or Regional Non-Interventional studies including regulatory commitments. This will include protocol development,...
The role requires strategic, operational and team leadership to drive and to deliver Medical Affairs initiatives that enable multiple product launches, while also supporting key...
This role plans clinical trials in accordance with company strategy and ensures their compliant and timely execution to final study report within budget. This role leads the...
To provide European regulatory strategy support for assigned projects, products and non-project work. Act as a specialist in the area of oncology. Represent Regulatory Affairs...
The role is responsible for ensuring Gilead’s medical affairs activities comply with pharmaceutical regulations and laws and providing expertise on drug safety and medical topics...
Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital health and other devices to enhance the value...
Responsibilities include project budget reviews, providing support to management, workload analysis, productivity and utilisation of resources and redistribution to ensure high...
Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and...
You will provide programming support to statisticians in production of summary tables, data listings and graphs required for clinical trials, and CDISC datasets for regulatory...
Manage local clinical/scientific programs in line with Brand Team and corporate requirements and ensure publication of the results of programs to ensure the highest standards in...
Act in this role primarily for clinical trial services and support all other categories in the R&D Development area; Own, manage and deliver on full procurement value agenda for...
The role is responsible for ensuring Gilead’s medical affairs activities comply with pharmaceutical regulations and laws and providing expertise on drug safety and medical...
As Regulatory Affairs representative in a matrix organisation you will be responsible for managing investigational and approved advanced medicinal therapy products on a national or...
You will act as the Global Regulatory Lead on more complex or multiple products, compounds, indications or projects in the established products therapeutic area. You will typically...
Accountable for leading the development and execution of innovative and value-added global regulatory strategies and responsible for formulating the Global Regulatory Project...
This is a pivotal new position within the Global Regulatory Labeling team, where you will lead and innovate in the packaging and labeling artwork creation, review, and approval...
Define and implement a global clinical supply strategy, in conjunction with mentor or experienced Drug Supply Manager. Ensure all clinical supplies (early phase, affiliate studies,...