freelance
Technical Writer Reference number: 1175
Last update: 05-11-2019, 10:27
Region: Braine L'Alleud
Sector: Pharmaceutical
Education: Bachelor
Job description
Technical Writer for late stage biological drug product development projects, especially for the authorship of CMC source documentation in support of the preparation of regulatory submissions.
What you’ll do
  • Authorship of CMC supporting documents (inlcuding protocols, reports and specifications) in relation to biologics drug product development and industrialisation
  • Ensure the accuracy of data and content of prepared documents prior to approval
  • Manage Review and Approval workflows for prepared documents, liaising with document reveiwers and approvers to ensuring timely approval of documentation in-line with project timelines
  • Provide support to the Knowledge Management Team for the appropriate management of data and information related to late stage development for biologics drug product
  • Continue to develop the structure and presentation of protocols and reports
Profile
  • Developing the structure and presentation of CMC documentation
  • Authorship of CMC supporting documentation.
  • Well organised, close attention to details and ability to meet pre-defined project timelines
  • Excellent communication, negotiation and team player skills are required as there will be significant contacts with transversal stakeholders.

  • Self-starting, proactive attitude is desirable, looking for opportunities to further develop the content and presentation of CMC supporting documents
  • High proficiency in written English
Required Skills
  • 2-3 years experience in technical writing / documentation authorship of CMC supporting documents.

  • Knowledge and understanding of biologics development and industrialisation
  • Understanding of CMC regulatory requirements
  • Bachelor or Master's degree
Interested? Send us your resumé
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Only PDF, max. 10MB