Principal Medical Writer, Global Medical Writing - Remote

Overview

This is an exciting leadership opportunity for a person with passion and talent. The company believes that medical writing is a science that continuously evolves with new regulations and technologies. The role provides the ability to influence company leaders and work on exciting fast-paced drug development programs. This is your chance to join a dynamic Medical Writing team and be part of an emerging success story driven by the company’s unwavering commitment to patients and employees.

In Short

• Lead writer for clinical programs and regulatory documents.
• Manage cross-functional teams for document development.
• Ensure high quality and adherence to regulatory guidelines.
• Maintain knowledge of current medical writing developments.
• Mentor junior medical writers.
• Perform medical literature searches.
• Review medical writing deliverables and statistical analysis plans.
• Participate in NDA/MAA/IND submission planning.
• Drive document strategies collaboratively.
• Plan and coordinate with in-house and external teams.

Requirements

• PhD or equivalent plus 5+ years of experience or Bachelors/Masters plus 10+ years of experience.
• Expert knowledge in clinical and regulatory document preparation.
• Experience with ICH regions submissions.
• Strong organizational and prioritization skills.
• Proficiency in eCTD templates and MS Office.
• Excellent verbal and written communication skills.
• Knowledge of clinical trial disclosure.
• Experience in oncology, immunology, or neurology preferred.
• Attention to detail in grammar, syntax, and accuracy.
• Ability to manage multiple concurrent projects.

Benefits

• Competitive salary and annual bonus.
• Comprehensive benefits package including medical, dental, and vision insurance.
• 401(k) retirement plan with company match.
• Generous parental leave and family planning benefits.
• Opportunities for personal and professional growth.