Remote Medical Writer II

Job Summary

Working remotely on a contract basis, the Remote Medical Writer II will manage the writing of clinical regulatory documents for various regulatory filings, ensuring adherence to guidelines and high-quality deliverables.

Key responsibilities

• Manage assigned writing tasks and ensure documents comply with regulatory guidelines and internal standards
• Oversee multiple documents simultaneously, ensuring timely and accurate completion with clear scientific messaging
• Initiate strategy meetings and facilitate communication between stakeholder organizations to support the Medical Writing team

Required qualifications

• Bachelor's degree in Life Sciences or Health Care Professions; Master's degree, PhD, or PharmD preferred
• Minimum of 7 years of medical writing experience in the pharmaceutical industry
• Experience as lead writer for significant documents in major US/EU and/or international regulatory submissions
• Strong understanding of clinical development phases and regulatory processes
• Knowledge of FDA/international regulations and ICH guidelines related to document preparation