CMC Technical Writer (m/f)

Description

• Write selected detailed sections of the CMC component of the submission plan
• Ensure that each detailed section interfaces with the summary report
• Ensure that the sections prepared all match the target format (i.e. meet page format specifications, match the master index, and ensure that all references, figures, and tables are appropriately hyperlinked)
• Prepare figures and tables where necessary (most will be provided by SMEs), checking adherence to regulatory requirements when necessary
• Ensure that all references are accurately reported
• Ensure that all data sources are correctly referenced and that data-sources are appropriately stored in regulatory systems
• Act as proof-reader for CMC sections not authored
• Liaise with SMEs to ensure provision of the necessary technical information
• Support the maintenance of the submission plan and supporting documents
• Liaise with regulatory staff to ensure delivered sections meet regulatory requirements, make adjustments to new/developing regulatory requirements and support the maintenance of the overall submission package (with particular reference to the CMC component)

• English skills on native speaker level with excellent skills in technical writing (scientific and regulatory)
• Ability to produce unambiguous, accurate text which is easy to read
• Ability to work with minimal supervision but within a team framework
• Ability to deliver to an aggressive project-plan
• Ability to adapt to changing plans and changing documentation requirements
• In-depth experience in the preparation of pharmaceutical CMC documentation or equivalent documentation experience for medical devices, preferably focussed on FDA
• Experience with a broad range of analytical methods (please document) or with a broad range of manufacturing techniques (again, please document)
• Expert knowledge of MS Word, good skills in Excel and Visio