Description
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 (e.g.CTD) 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 (e.g., Documentum) or document-sharing systems (e.g.SharePoint).
• Collaborate with regulatory product managers and with internal partners.
Requirements
• Good scientific background (e.g.minimum 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 (e.g.Documentum) and document-sharing systems (e.g.SharePoint).
• 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 (e.g., 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.