Senior Medical Writer

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

📋 Description

• Spearhead 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.

• Direct 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 interpret and analyze clinical trial data and encapsulate scientific findings.

• Engage in the planning and execution of clinical development programs, offering strategic insights and scientific knowledge.

• 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 techniques, and scientific principles.

• Promote excellence, collaboration, and ongoing education within the medical writing team.

⛳️ Requirements

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

• Proficient in interpreting and summarizing intricate clinical trial data, scientific research outcomes, and statistical analyses.

• Exceptional writing, editing, and proofreading abilities.

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

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

• Capability to thrive in a dynamic, deadline-driven environment.

• Aptitude for managing multiple projects concurrently and prioritizing tasks according to project timelines and deliverables.

• Outstanding interpersonal and communication skills.

• Ability to effectively collaborate with cross-functional teams, build 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 plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellness resources.

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