Lead Medical Writer

This is a fully remote position, open to applicants in Brazil, +1 more country.

📋 Description

• Lead the formulation and implementation of medical writing strategies for clinical research initiatives.

• Take ownership of medical writing deliverables and leverage expertise to address complex challenges.

• Oversee the preparation, review, and editing of clinical study protocols, clinical study reports, investigator brochures, and regulatory submissions.

• Collaborate with clinical research, biostatistics, regulatory affairs, and medical affairs teams to analyze clinical trial data and summarize scientific results.

• Engage in the planning and execution of clinical development programs.

• Provide strategic insights and scientific expertise for the design, execution, and interpretation of clinical studies and research projects.

• Contribute to publication strategies, abstracts, posters, and manuscripts for peer-reviewed journals and scientific conferences.

• Mentor and guide junior medical writers on best practices, writing methods, and scientific principles.

• Promote a culture of excellence, collaboration, and continuous learning within the medical writing team.

⛳️ Requirements

• Bachelor's degree in a relevant scientific discipline or a healthcare-related field.

• Expertise in interpreting and summarizing intricate clinical trial data, scientific research results, and statistical analyses.

• Exceptional writing, editing, and proofreading abilities.

• Strong knowledge of regulatory standards, including ICH-GCP, FDA, and EMA, related to the preparation and submission of clinical documents and publications.

• Experience engaging with regulatory agencies during the review and approval stages.

• Capability to thrive in a fast-paced, deadline-oriented environment.

• Proficiency in managing multiple projects concurrently and prioritizing tasks based on project timelines and deliverables.

• Outstanding interpersonal and communication skills.

• Ability to effectively collaborate with cross-functional teams, establish relationships with key stakeholders, and influence decision-making processes.

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary and performance-based incentives.

• Health and wellness programs including medical, dental, and vision coverage where applicable.

• Retirement and pension schemes.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Learning and development opportunities through structured training and career pathways.