Regulatory Content Specialist

Há 2 dias

São Paulo, São Paulo, Brasil beBeeRegulatory Tempo inteiro R$60.000 - R$82.000
Senior Regulatory Writing Specialist Job Description

We are seeking an experienced Senior Regulatory Writing Specialist to join our team.

Job Summary:

The Senior Regulatory Writing Specialist is a professional responsible for creating regulatory materials in alignment with regulatory and compliance practices.

Key Responsibilities:

  • Serve as lead writer on regulatory documents, including protocols, CSRs, briefing books, INDs, and NDAs.
  • Manage timelines and communications for concurrent writing projects.
  • Organize and lead document review meetings with cross-functional teams.
  • Ensure clarity, consistency, and accuracy across all assigned deliverables.
  • Perform document-level quality control review and contribute to peer reviews.
  • Collaborate with subject matter experts to resolve feedback and align messaging.
  • Develop project-level lexicons and conventions.

Qualifications:

  • Above average attention to detail, teamwork, and initiative.
  • Ability to interact with other departments within the organization.
  • Proficient in Microsoft Word, Excel, PowerPoint, and Outlook.
  • Ability to apply regulatory guidelines to content development.

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