Senior Medical Writer

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Oversee the planning and creation of high-quality clinical regulatory documents.

• Collaborate across various functions, including Clinical Development, Clinical Operations, Biostatistics, Regulatory Affairs, and Program Management client teams.

• Generate protocols, publications, study reports, investigator brochures, narratives, and module documents in accordance with client and regulatory agency guidelines.

• Manage document execution and project management activities, including developing, maintaining, and communicating timelines.

• Coordinate contributions from clients, stakeholders, and internal resources such as quality control and publishing teams.

• Ensure that document development adheres to client processes, templates, and instructional materials.

• Act as an authority on client document management systems, tools, templates, and procedures.

• Guide the development of document messaging in collaboration with clients.

• Analyze data and create shell documents to facilitate authorship.

• Organize and lead kickoff meetings.

• Manage the resolution of review feedback and lead meetings focused on comment resolution.

• Follow up with team members to address any outstanding review feedback.

• Guarantee consistency in messaging, formatting, and presentation across client programs.

• Conduct literature searches as necessary.

• Perform peer quality control reviews as required.

• Contribute to medical writing operational initiatives, including templates, style guides, and reference management.

⛳️ Requirements

• Minimum of 5 years of experience as a medical writer within the CRO/biotech/pharmaceutical industry.

• Bachelor’s degree or higher in a relevant discipline.

• Experience in Oncology, Infectious Disease, or Vaccine development is preferred.

• Proficiency in writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5 documents is highly desirable.

• Willingness to work across various therapeutic areas as needed.

• Experience in creating documents that adhere to established processes and document templates.

• Familiarity with lean authoring methodologies and structured content management.

• Understanding of the requirements for key clinical and regulatory documents, including ICH and US regulatory standards; knowledge of ex-US regulatory requirements is preferred.

• Proficient in Microsoft Word and other Microsoft Office applications.

• Experience in developing documents using document management systems, collaborative authoring tools, and review software.

• Ability to adapt to new tools and technologies as required.

• Capacity to work both independently and collaboratively while managing competing priorities.

• Service-oriented and proactive attitude towards project management.

• Strong conflict management and negotiation capabilities.

• Comfortable providing recommendations based on previous experiences.

• Excellent written and verbal communication skills in English.

• Must reside in Brazil and have legal authorization to work there.

🏝️ Benefits

• Equal employment opportunity regardless of race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.