Beschreibung
Our client, a global pharmaceutical company is looking for an experienced CMC Documentation Specialist to support their site in the greater Basel area to review CMC documents for a new injectable productStart: As soon as possible
Duration: 4 months +
Location: Basel area, Switzerland
Role and Responsibilities
Prepare and update technical regulatory documents according to instructions and ensure adherence to applicable regulatory (egCTD) and internal documentation standards.
Apply document formats using customised Word templates and formats detailed data tables and figures.
Import and maintain documents in document management systems (eg, Documentum) or document-sharing systems (egSharePoint).
Collaborate with regulatory product managers and with internal partners.
Requirements
Good scientific background (egminimum education as labour specialist or BA/BS (or equivalent) in chemistry, biology or pharmacy).
Biopharma/chemistry/regulatory affairs/CMC experience
Expert-level use of Word, Excel, and Acrobat and experience with document-management systems (egDocumentum) and document-sharing systems (egSharePoint).
Tenacious attention to detail and consistency, especially with respect to style, format, and layout and ability to format technical regulatory documents using electronic tools.
Previous experience with regulatory documents and dossier structures (eg, CTD ) or in the biotech or pharmaceutical industry is beneficial.
Ability to communicate clearly and professionally, both orally and in writing.
Fluent English and German skills required.
Strong organisational and time-management skills the ability to deliver under pressure and the ability to work in teams and in an independent and reliable manner.