Job Description

Accountabilities:

• Critically evaluate and interpret medical literature to identify appropriate primary sources, assessing study design, statistical significance, scientific rigor, and potential bias.
• Author and edit clinical development and regulatory documents, including clinical study protocols, investigator brochures, clinical study reports, informed consent forms, integrated safety and efficacy summaries, Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentations, and scientific publications.
• Manage writing assignments efficiently, ensuring high-quality deliverables are completed within established timelines.
• Maintain project timelines, workflows, and priorities across multiple concurrent writing assignments.
• Apply expert knowledge of regulatory writing conventions, client templates, and document style guides.
• Work directly and independently with clients to coordinate project requirements, clarify expectations, and manage communication throughout assignments.
• Take ownership of assigned projects while proactively collaborating with project teams and subject matter experts to obtain required information and guidance.
• Contribute substantially to, or lead, the development of interpretive guides and other supporting materials.
• Provide mentorship and guidance to medical writers and other project team members involved in the writing process.
• Support project leadership and contribute to the successful delivery of regulatory documentation under demanding timelines.

Requirements:

• At least 3 years of experience in the pharmaceutical industry, with approximately 3–5 years of experience specifically in regulatory and clinical medical writing.
• Bachelor’s, Master’s, or Ph.D. degree in a scientific, medical, clinical, or related discipline.
• Substantial experience authoring clinical study protocols as a lead author.
• Demonstrated experience leading or managing teams while producing regulatory documents within aggressive timelines.
• Experience with regulatory submissions and clinical study reports submitted to health authorities is highly desirable.
• Strong understanding of clinical data and the ability to accurately interpret complex scientific information.
• Exceptional written communication and scientific writing skills.
• Strong knowledge of regulatory document structures, writing conventions, and applicable style requirements.
• Advanced proficiency with Microsoft Word, Excel, PowerPoint, and related document-production tools.
• Experience acting as a project lead or managing project teams.
• Strong organizational and time-management skills, with the ability to manage multiple priorities simultaneously.
• Strong client-facing communication skills and the ability to collaborate effectively with multidisciplinary teams.
• Knowledge of federal regulations, Good Clinical Practice (GCP), and ICH guidelines is a plus.
• Experience with orphan drug designations and PSP/PIPs is an additional advantage.

Benefits:

• Fully remote position, available from anywhere in Brazil.
• Full-time employment.
• Opportunity to work on clinical development and regulatory projects across the pharmaceutical, biotechnology, and medical device sectors.
• Exposure to complex clinical data, regulatory submissions, and international clinical research projects.
• Collaborative environment with opportunities to work alongside experienced scientific and medical writing professionals.
• Opportunities to mentor colleagues and develop project leadership capabilities.
• Professional exposure to a broad range of regulatory and clinical document types.