Principal Medical Writer

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

📋 Description

• Manage medical writing workstreams to ensure that deliverables align with quality and timeline expectations.

• Take the lead in preparing and reviewing clinical study reports, protocols, and various regulatory documents.

• Collaborate with teams in clinical research, biostatistics, and regulatory affairs to collect and synthesize information.

• Offer guidance on best practices in medical writing, ensuring compliance with regulatory requirements and internal standards.

• Mentor and train junior medical writers.

• Keep updated with industry trends and regulatory guidelines.

• Serve as the lead medical writer for complex projects.

• Oversee the writing of clinical and regulatory marketing approval applications for new biologics and drugs.

• Execute all responsibilities of a Senior Medical Writer, in addition to leading the writing of regulatory approval applications.

⛳️ Requirements

• A bachelor’s degree in life sciences, pharmacy, or a related field.

• Extensive experience in medical writing, especially in regulatory submissions and clinical documentation.

• Strong comprehension of regulatory requirements and industry standards for clinical writing.

• Outstanding writing and editing skills, with a strong attention to detail and clarity.

• Excellent communication and interpersonal abilities, facilitating effective collaboration with diverse teams and stakeholders.

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

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

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

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellbeing resources.

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