Country Submission Specialist
Location: BelgiumSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Pharmaceutical organization, based in Brussel Belgium.
They provide stimulating jobs in a fast-paced environment with colleagues from many different nations and cultures. In an environment that promotes flexibility and openness towards new ideas. This allows you to work in the way that is best for you, and fosters an entrepreneurial mindset that enhances their competitiveness. This positive environment will help you to achieve even more in your career
ROLE DESCRIPTION
For a period of 6 months you will be responsible for submissions. Giving the essential push to finalise the current key projects.
RESPONSIBILITIES
• Local requirements for documentation of submission approvals
• Liaise with study sites regarding essential document collection
• Compile and submit CTAs to Regulatory Authorities
• Arrange and review translations of relevant study documents.
• Provide regular local status updates to project lead.
• Ensure all relevant documents are submitted to the Trial Master File
• Support other departments as necessary
• Train and mentor other associates on local regulations and internal procedures.
• Complete necessary administrative tasks.
REQUIREMENTS
• Undergraduate degree in a related field or higher
• Solid clinical research/monitoring experience including study start-up experience
• Knowledge of Good Clinical Practice/ICH Guidelines
• Strong organizational skills
• Ability to communicate in English, Dutch and French is a plus
• Occasional travel may be required
OTHER
Excellent benefits.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees van Wezel.
