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Technical Writer

  • Locatie:

    Cork, Ierland

  • Contactpersoon:

    Steve Murphy

  • Contractsoorten:

    Contract

  • Telefoon contactpersoon:

    +31 (0)20 406 97 50

  • Bedrijfssectoren:

    Pharmaceutical

  • E-mail contactpersoon:

    Richard_molloy@oxfordcorp.com

Project:
The expert will collect data/information across all functions; Manufacturing, Production, Quality/Regulatory etc from the Audits in order to create technical responses & documents which the Client will submit back to the FDA post audit.
The project is eight weeks starting April 14th. The first 3 weeks are fully on site, the role is more flexible for the remaining five weeks. The site is based near Bandon, Cork.

Key Responsibilities:

  • Collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, and Research & Development & Manufacturing to gather and analyze data related to post-audit findings.
  • Develop comprehensive technical documents and responses tailored to the specific requirements of the FDA,
  • The technical writer expert will have to organize & collate all of the information & documentation into a coherent document
  • In the words of the manager "organize the data in the technical document & tell the story in a coherent way, that can be submitted to the FDA as part of our response"
  • They will also be inspected by the Korean & Turkish health authorities - experience with these regulations is nice to have but not essential- the FDA experience is however
  • Function of expert will be more "execution as opposed to consultative" They don't need guidance on which data to input , rather a steer on how to formulate a coherent & accurate Technical Document



Profile

  • Minimum of 3 years of experience in technical writing within the pharmaceutical or biotechnology industry.
  • Proven expertise as a Technical Writer & with responding to FDA audits
  • Exposure to c-GMP & FDA regulations
  • Exceptional writing, editing, and communication skills with a keen attention to detail.
  • Ability to translate complex scientific concepts into clear, concise, and accurate technical documents.
  • Site is a vaccines manufacturer so experience with large molecules would be ideal


On site : fulltime on site for three weeks outside Bandon, remaining five weeks are more flexible

Start Date: 14th of April