Regulatory Document Management Specialist - Mechelen, BE

Job description

Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Belgium (Mechelen), France (Romainville), the Netherlands (Leiden), Switzerland (Basel), and in the US (Boston).


We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We want to challenge the impossible. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you: The ones who ‘make-it-happen’.


We are looking for a Regulatory Document Management Specialist


Scope of the job

 

In this position, you keep our new Document Management System in tiptop shape and take the role of the System’s Business administrator dealing with the system's metadata and supporting requests to help our users. You will work with various departments to get our documents and templates organised and formatted according to Regulatory requirements and GLPG (Galapagos) standards.


Your role

 

  • This responsibility will include the (technical) formatting of scientific and regulatory templates and documents (MS Word or Adobe Acrobat) for submissions to EMA/FDA and other health organizations around the world.
  • Collaborate with cross-functional business partners providing direction and expertise in formatting and publishing of submission related templates and documents, promptly communicating irregularities in documents and coordinating issue resolution;
  • Independently manage DMS electronic study report binders: collection of Clinical Study Report documents and appendices to include into the binder via upload or cross referencing with eTMF;
  • QC Clinical Study Report Submission binders on binder correctness and completion state;
  • Perform DMS business admin tasks such as setting up metadata and assist with queries etc.
  • Provide day-to-day support activities as and when necessary to aide completion of documents, templates and system workflows or metadata.


Requirements


  • Min. Bachelor’s degree in Business Administration, Sciences, Pharmacy, Chemistry or related field
  • Min. 3 years experience within the pharmaceutical or regulatory publishing industry
  • Regulatory documentation background
  • In depth knowledge of document management tools, eCTD documentation standards and publishing work flows
  • Formatting and publishing of internal and externally authored regulatory documents and templates
  • This is a fast-paced environment where you need to multi-task and be flexible
  • Effective interpersonal skills to work well in a matrix team environment and with international colleagues at all levels in the organization
  • High quality of work: attention to detail and strong methodical document follow up skills
  • Demonstrated ability to work autonomously and manage multiple project timelines
  • Intermediate knowledge of Microsoft Office Suite with an emphasis on Microsoft Word functions
  • Working knowledge of Adobe Acrobat and Document Management Systems
  • Strong written and verbal communication in English

 

What’s in it for you? 

You will be part of a fast growing and amazing company. As ‘make-it-happener’ you will get all the support you need to make your job successful. At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.


We are Galapagos : together we can make it happen…!