Medical Writer

3 semanas atrás

São Paulo, São Paulo, Brasil Med Communications Tempo inteiro
Regulatory Writer - Senior Regulatory Writing Specialist

Join to apply for the Regulatory Writer - Senior Regulatory Writing Specialist role at Med Communications

Regulatory Writer - Senior Regulatory Writing Specialist

2 days ago Be among the first 25 applicants

Join to apply for the Regulatory Writer - Senior Regulatory Writing Specialist role at Med Communications

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Medical Writing - Regulatory Writing - Regulatory Affairs
Essentials:
Degree: Advanced degree in a scientific discipline (eg, life sciences, pharmacy, medicine) or relevant work experience; or equivalent combination of education, training, and experience.
Experience: At least 3 years as a Regulatory Writer
Fluent: C1 or C2 - English Speaker
Brazil Remote
Position Summary
The Senior Regulatory Writing Specialist is a professional responsible for the creation of regulatory materials for investigational and marketed products in alignment with regulatory and compliance practices. The individual will work directly with client teams to manage regulatory writing projects.
Essential Functions
To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodation may be made to help enable qualified individuals with disabilities to perform the essential functions.
Essential Functions Statements

  • Serve as lead writer on regulatory documents (e.g., protocols, CSRs, briefing books, INDs, NDAs).
  • Manage timelines and communications for at least three concurrent writing projects.
  • Organize and lead document review meetings with cross-functional teams, clarify and incorporate feedback, work with cross-functional subject matter experts to resolve unclear comments and differences of opinion between functional areas.
  • Ensure clarity, consistency, and accuracy across all assigned deliverables.
  • Perform document-level quality control review (including abbreviations, references to sources, data in text versus data in tables, figures, or graphs, etc.) and contribute to peer reviews (logical flow, sense check etc.).
  • Collaborate with subject matter experts to resolve feedback and align messaging.
  • Contribute to writing process improvements, SOP development, and best practices documentation.
  • Support training or mentoring of less experienced writers on specific document types.
  • Develops project-level lexicons and conventions.

Position Qualifications
  • Above average attention to detail, teamwork and initiative.
  • Ability to interact with other departments within the company and be proficient in written and verbal communication.
  • Proficient in Microsoft Word, Excel, Power Point, and Outlook, and quickly able to learn new software.
  • Ability to apply regulatory guidelines to content development.

Competency Statements
Ethical - Ability to conform to a set of values and accepted standards.
Accountability - Ability to accept responsibility and

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