Submissions Technical Expert | Big Pharma | Leiden,

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The company

Our client is a professional Pharmaceutical and Biotechnology organisation, based in Zuid-Holland Netherlands. For 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 description

As 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.

Responsibilities

Your 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.

Other information

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.

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