Senior Medical Writer

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

📋 Description

• Deliver medical writing assistance for the development of intricate clinical, nonclinical, and safety documents aimed at regulatory submissions.

• Implement the overarching strategy for all medical writing procedures in alignment with argenx medical writing standards and corporate goals.

• Author and oversee subject matter expert contributions to create content for regulatory submissions.

• Ensure that content is organized, consistent, accurate, and adheres to argenx Medical Writing standards, including the style guide, lexicon, templates, and libraries.

• Compose content for phase 1-4 protocols, master informed consent forms (ICFs), investigator brochures (IBs), and clinical study reports (CSRs).

• Guarantee the inspection-readiness of all medical writing activities.

• Assist the lead writer and project teams in meeting project deadlines.

• Implement corporate objectives, goals, measures, and strategies.

• Manage multiple deliverables concurrently.

⛳️ Requirements

• A bachelor's degree in a scientific or clinical discipline or a related field is mandatory; a Ph.D. is preferred.

• A minimum of 3 years of relevant experience in sponsor-level pharmaceutical or biotech clinical/regulatory medical writing is required; experience with contract research organizations (CROs) will be considered.

• Native/bilingual or fluent proficiency in American English.

• Familiarity with Veeva Vault and Please Review.

• Experience in utilizing lean writing techniques.

• Basic understanding of scientific methodology as it pertains to drug development, including the phases, processes, and techniques employed within a clinical development context from protocol design to regulatory submission.

• Knowledge of pharmacovigilance guidelines and the creation of aggregate reports.

• Capability to work meticulously in accordance with procedures and regulations.

• Ability to effectively prioritize and manage multiple tasks in a dynamic environment.

• Competence to work independently as well as collaboratively within a team.

• Outstanding written and verbal communication skills.

• Exceptional time management skills and a proven track record of handling multiple projects simultaneously.

• Proficiency in MS Office is essential.

🏝️ Benefits

• Short-term incentive programs.

• Long-term incentive programs.

• Retirement savings plans.

• Health benefits.

• Comprehensive benefits package.