Senior Medical Writer

This is a fully remote position, open to applicants in Pennsylvania.

📋 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, investigator brochures, regulatory submissions, and other related documents.

• Work collaboratively with clinical research, biostatistics, regulatory affairs, and medical affairs teams to interpret clinical trial data and summarize scientific findings.

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

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

• 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.

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

⛳️ Requirements

• Bachelor's degree in a pertinent 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, that govern clinical documents and publications.

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

• Capability to work independently in a dynamic, deadline-oriented environment.

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

• Outstanding interpersonal and communication skills.

• Ability to 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 along with performance-related incentives.

• Comprehensive health and wellbeing programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension schemes.

• Life assurance and disability coverage.

• Employee assistance programs and wellbeing resources.

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