Lead Medical Writer

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

📋 Description

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

• Take ownership of medical writing outputs and leverage expertise to tackle complex challenges.

• Draft, review, and refine clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), and regulatory submissions.

• Collaborate with teams in clinical research, biostatistics, regulatory affairs, and medical affairs.

• Interpret and evaluate clinical trial data while summarizing scientific results.

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

• Offer strategic insights and scientific knowledge for the design, execution, and analysis of clinical studies and research initiatives.

• Create publication plans, abstracts, posters, and manuscripts for submission to peer-reviewed journals and scientific conferences.

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

⛳️ Requirements

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

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

• Exceptional writing, editing, and proofreading abilities.

• Strong grasp of regulatory standards (e.g., ICH-GCP, FDA, EMA) governing the preparation and submission of clinical documentation and publications.

• Experience in liaising with regulatory bodies during the review and approval phases.

• Capable of thriving in a fast-paced, deadline-oriented environment.

• Proficient in managing multiple projects concurrently and prioritizing tasks according to project timelines and outputs.

• Outstanding interpersonal and communication skills.

• Ability to work collaboratively with cross-functional teams, cultivate 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 along with performance-related 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.

• Opportunities for learning and development through structured training and career advancement pathways.