Senior Medical Writer

This is a fully remote position, open to applicants in United States, +2 more locations.

📋 Description

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

• Draft, review, and refine clinical study protocols, reports, investigator brochures, regulatory submissions, and various clinical documents.

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

• Analyze and interpret clinical trial data, summarizing scientific results effectively.

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

• Offer strategic insights and scientific knowledge to aid in the design, execution, and interpretation of clinical studies and research projects.

• Assist in the development of publication plans, abstracts, posters, and manuscripts intended for peer-reviewed journals and scientific conferences.

• Guide and mentor junior medical writers on best practices, writing skills, and scientific principles.

• Promote excellence, teamwork, and ongoing learning within the medical writing team.

⛳️ Requirements

• A 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 capabilities.

• Strong knowledge of regulatory standards, including ICH-GCP, FDA, and EMA, that govern clinical documents and publications.

• Experience in engaging with regulatory agencies throughout the review and approval process.

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

• Capacity to juggle multiple projects simultaneously and prioritize tasks according to project timelines and deliverables.

• Outstanding interpersonal and communication skills.

• Proficient in collaborating with cross-functional teams, building relationships with stakeholders, and influencing decision-making processes.

• Authorized 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 insurance where applicable.

• Retirement and pension plans available.

• Life insurance and disability coverage provided.

• Employee assistance programs and wellness resources offered.

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