Submissions Technical Expert | Big Pharma | Leiden,
SIRE Life Sciences®
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SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences 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!Our client is a professional Pharmaceutical and Biotechnology organisation, based in Zuid-Holland Netherlands.
The CompanyFor more than 25 years, Janssen Biologics has been a leader in the field of biomedicines. Through the dynamic science of biotechnology, they continue to seek innovative ways to treat cancer, infectious diseases, cardiovascular and metabolic diseases, and immune-mediated inflammatory disorders. Their work has revolutionized the science of immunology. They pioneered monoclonal antibody technology, a cutting-edge approach that launched a new generation of products to treat immune-related diseases. Janssen Biologics is a wholly owned subsidiary of Johnson & Johnson.
Role DescriptionAs the RA Submission Technical Expert you will be responsible for supporting the tools used for electronic publishing of regulatory submissions by RSMO Publishing and Local Operating Companies, working independently with minimal supervision. Moreover you will support the training of junior specialists and oversee the work of others from an operational perspective to ensure quality of output.
You may also be assigned various independent or team-based projects primarily focused on process improvement initiatives or the testing and implementation of new submission related technologies.
You are expected to identify opportunities to streamline processes or enhance overall quality of output.
ResponsibilitiesYour time will be divided as follows:
• Support current electronic document management and publishing tools to assemble and publish dossiers according to regulatory requirements for paper and electronic submissions. 40%
• Troubleshoot and provide first-line support to RSMO Publishing. Serve as a helpdesk for inquiries regarding regulatory requirements and guidelines. 40%
• Monitor electronic publishing requirements and determine the scope for tool maintenance/development. 5%
• Assess processes to ensure that organizational responsibilities are met for quality, delivery, and effectiveness. 5%
• Develop opportunities for business process improvement. 5%
• Assist in technical training of team members & provide ongoing guidance to ensure internal standards/procedures are adhered to. 5%
Requirements• Must have enough experience in pharmaceutical industry submission publishing or related technical skills to be able to operate independently in this role.
• Proficiency in submission related FDA or EU regulations & guidelines e.g., eCTD
• Expert working knowledge of Publishing related tools, like InSight Publisher, ISI Publisher, InSight for Validation, Extedo Global Validator, Lorenz eValidator, InSight for Viewing, ISI Toolbox etc. .
• Affinity of experience with GMP.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.