CMC Documentation Specialist

Switzerland  ‐ Onsite
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Keywords

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 product

Start: 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.
Start date
n.a
From
Quanta Consultancy Services
Published at
05.09.2014
Contact person:
Lee Mitchell
Project ID:
770602
Contract type
Freelance
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