Senior Medical Writer

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

📋 Description

• Oversee the implementation of clinical regulatory documents and related project management activities.

• Develop, update, and convey project timelines effectively.

• Facilitate collaboration among cross-functional client contributors, stakeholders, and internal resources, including quality control and publishing.

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

• Act as a specialist on client document management systems, tools, templates, and protocols.

• Guide the development of document messaging with clients.

• Analyze data and create initial document templates to assist in writing.

• Organize and lead kickoff meetings.

• Manage the resolution of review feedback and conduct meetings for comment resolution.

• Compile review comments and follow up with team members regarding outstanding feedback.

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

• Conduct literature searches as necessary.

• Execute peer quality-control reviews as required.

• Participate in 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 Vaccines is preferred.

• Proven experience in writing clinical study reports, protocols, protocol amendments, investigator brochures, Module 2, and Module 5 documents is desirable.

• Ability to adapt to multiple therapeutic areas.

• Experience in authoring documents in accordance with established procedures and templates.

• Understanding of lean authoring methodologies and structured content management.

• Familiarity with the requirements for key clinical and regulatory documents, including ICH and US regulatory standards.

• Knowledge of ex-US regulatory requirements is a plus.

• Proficient in Microsoft Word and other Microsoft applications.

• Experience in developing documents utilizing document management systems, collaborative authoring tools, and review platforms.

• Comfortable with adapting to new tools and technologies.

• Capable of working both independently and collaboratively while managing competing priorities.

• Service-oriented and proactive approach to project management.

• Strong conflict resolution and negotiation skills.

• Excellent written and verbal communication skills in English.

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

🏝️ Benefits

• Full-time, permanent employment opportunity.

• Commitment to equal employment opportunities.

• Remote work arrangement available in Brazil.

• Chance to collaborate with cross-functional client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management.