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Prepare Documents as per
FDA-Specific Record Standards

LOCATION: â€‹Schering-Plough (contract)

SITUATION:  

Schering-Plough had defined a need to convert a large number of documents from paper to digital format, implementing FDA-specific record standards, within a restricted timeline.

NEEDS DEFINITION:  

As a result of the time frame, this department gathered a team of individuals from other parts of the company with little knowledge of the types of document to be converted and no knowledge of the standards to be used.

ACTIVITY:

​ After completing a review of the standards and learning details of the templates to be used, produced a set job aids for technical writing team specific to:

  • Rules for applying standard format conventions.

  • Grammatical requirements for each form type.

  • Required and optional field requirements for each form type.

  • Peer Review checklist criteria and implementation.

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Activities also included:

  • Assist in training new editors and writers on best practices in writing and editing.

  • Work closely with writers to provide feedback and guidance on content improvement.

  • Examine documents for clarity, coherence, and consistency.

  • Correct grammatical, punctuation, and spelling errors while enhancing overall readability.

  • Ensure all documents comply with established style guides and formatting requirements.

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