Associate Director – Regulatory Systems
PRA Health Sciences
UK, France, Belgium, the Netherlands, Spain, Italy, Germany, Sweden, Denmark, France
1 dag geleden
source : PharmiWeb.com

Position overview : Working as part of a client-dedicated global program, you will assume responsibility for the management of major regulatory technology projects and programs.

Key responsibilities will include to : Manage projects and programs throughout the full project lifecycle; from the development of business cases, defining scope and objectives, design, testing, implementation and post-

implementation engagement. Manage project resources, issues, risks and budgets Develop and maintain the regulatory systems and tools, and support the user community (3000+) across the portfolio of information systems required to meet the needs of the global regulatory affairs organization.

This will include electronic document management (EDMS), publishing, viewing, validation, compilation, labelling, regulatory chemistry, manufacturing and controls (CMC) and regulatory information management systems.

Define and execute on change management strategies for projects, including delivery of training when appropriate Identify, select and manage relevant technology partners Govern the systems in production by monitoring user challenges and issues, prioritizing and managing associated system change requests.

Participating in system improvement projects. Supporting validation activities to ensure that quality solutions are delivered to the end user to meet set business requirements as well as to conform to company technology principles, architecture, and strategies.

Keeping abreast of regulatory and industry changes that may impact global regulatory operations, interpreting regulatory guidance as related to systems and making plans to adapt company systems and processes as appropriate.

In this role, you will work closely alongside Information Technology and senior management to ensure a collaborative working environment and ultimate successful execution on business-

critical projects. You are : Collaborative, analytical and innovative. Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support.

To enable success in this position you will have : A track record of success in project management A strong background in regulatory affairs, including an understanding of document management, regulatory information management, publishing, CMC etc Expert business analysis skills Able to quickly learn new applications, processes and procedures A degree-

level qualification in a relevant discipline, and a project management qualification would be advantageous, but not essential Your health, your family, your career, your money the things that matter to you, matter to us.

The benefits of PRA just get better and better. PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.

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