Senior Medical Writer

argenx

. Provide medical writing support for developing complex clinical, nonclinical, and safety documents for regulatory submissions .

Posted 10/9/2026full-timeRemote • United StatesSenior💰 $128,000 - $176,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in medical writing for regulatory submissions, including authoring and project management of clinical documents while ensuring compliance with established standards. Proficient in managing multiple projects and deadlines in a fast-paced environment.

Highest-signal resume keywords

Medical Writing ExperienceRegulatory SubmissionsVeeva VaultLean Writing TechniquesPharmacovigilance Guidelines

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Document AuthoringProject ManagementScientific MethodologyProtocol DesignAggregate Report Development

Soft Skills

Excellent Communication SkillsTime ManagementAutonomous WorkTeam CollaborationMulti-tasking

Tools & Technologies

MS OfficePlease Review

Industry Keywords

PharmaBiotechCROInspection-readinessClinical Development

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

Provide medical writing support for developing complex clinical, nonclinical, and safety documents for regulatory submissions
Execute the overall strategy for all medical writing processes according to argenx medical writing standards and corporate objectives
Author and project manage SME contribution to develop content for regulatory submissions
Ensure content is well-organized, consistent, accurate, and compliant with argenx Medical Writing standards, including style guide, lexicon, templates, and libraries
Author content for phase 1-4 protocols, master ICFs, IBs, and CSRs
Ensure inspection-readiness of medical writing activities
Support the lead writer and project teams to ensure project deadlines are met
Execute corporate objectives, goals, measures, and strategies
Work on multiple deliverables simultaneously

Requirements

What you’ll need

Bachelor’s degree in a scientific or clinical discipline or related field is required; Ph.D. preferred
Minimum of 3 years of related, sponsor-level pharma or biotech clinical/regulatory medical writing experience required; CRO experience considered
Native/bilingual or fluent American English proficiency
Experience with Veeva Vault and Please Review
Experience with implementing lean writing techniques
Basic understanding of scientific methodology as applied to drug development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission
Familiarity with pharmacovigilance guidelines and developing aggregate reports
Ability to work precisely according to procedures and regulations
Ability to prioritize and multi-task successfully in a fast-paced environment
Ability to work autonomously, as well as in a team
Excellent written and verbal communication skills
Excellent time management skills and a proven ability to work on multiple projects at any given time
Must be proficient in MS Office

Benefits

Comp & perks

Short-term incentive programs
Long-term incentive programs
Retirement savings plans
Health benefits
Comprehensive benefits package