Derks Vacature Regulatory Affairs

Document Migration Specialist

Derks & Derks Detachering

A temporary assignment for one year at a large pharmaceutical company

Offer
  • a challenging job within a large pharmaceutical company
  • a temporary assignment till 31-05-2022
  • contract of Derks & Derks Secondment & Interim
Position

As a Document Migration Specialist, you will be working in the migration process of a document management system used in the company (within Veeva Vault Platform). In this position you will be responsible to migrate and reclassify documents, both paper and electronic originals (protocols, reports, raw data, literature articles, biologic documents, CMC documents, batch release documents, detailed and critical summaries, sponsor reports, etc.) and upload (scan when necessary) them to the production environment. You will also be required to review and identify documents to determine the appropriate classifications of biologics, clinical, CMC, drug discovery, preclinical, regulatory, statistics, etc, as well as request new study numbers, project codes as necessary, to ensure the accuracy and clearness of the information loaded to the new system.

Profile
  • bachelor’s degree (or equivalent work experience) with 7 years’ experience in a related field and/or industry
  • knowledge of scientific R&D documents within Animal Health or Life Sciences industry is required
  • knowledge and understanding of EPA, FDA GxP, FDA CFR 21 Part 11, OECD GLP, USDA, and VICH regulations and guidelines
  • prior experience with reading and comprehension of biologics, clinical and/or preclinical study related documentation
  • expertise in the understanding of Document Management Systems (preferable Veeva Vault) and/or other repositories
  • expertise in office related software (Microsoft Excel, Microsoft Word, Acrobat, etc.)
  • good communication skills in English, Dutch is a plus
Organisation

Our client is a world leader in the healthcare industry. Through their medicines, vaccines, biological therapies, and support services, they offer health solutions for people and animals in more than 140 countries. They also demonstrate their commitment to an increasing access to healthcare through far-reaching programs that donate and deliver their products to the people who need them. The organisation has three main locations with approximately 4,500 employees. This position is located in Haarlem.

Response

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/21-081-DD, to Renato Marques: info@derksenderks.nl.

For further information, please call Renato Marques at number +31 (0)33 472 80 87.

An individual assessment may be part of the selection procedure.

Our client has chosen Derks & Derks Secondment & Interim as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

If this is not quite the position you are seeking, please check http://www.derksenderks.nl/vacatures for other interesting jobs!

Tagged as: Life Sciences

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