Associate Director, Medical Writing Job at argenx in Phila

Why consider this job opportunity

Salary up to $246,000

Opportunity to participate in short‑term and long‑term incentive programs

Comprehensive benefits package, including retirement savings plans and health benefits

Chance to contribute to innovative therapies that help autoimmune patients

Collaborative work environment with a focus on professional growth

Remote work flexibility available

What to Expect (Job Responsibilities)

Serve as the primary author for various regulatory documents, including protocols, IBs, and CSRs

Collaborate with subject matter experts to ensure content is accurate and compliant

Maintain inspection‑readiness for all medical writing activities

Standardize documents using templates and style guides for consistency

Manage and support medical writers and external vendors on regulatory submissions

What is Required (Qualifications)

Bachelor’s degree in a scientific or clinical discipline; PhD preferred

Minimum of 5 years of sponsor‑level pharma or biotech clinical / regulatory medical writing experience

Proficiency in American English, native or bilingual level

Strong understanding of scientific methodology and regulatory guidance for medical writing

Excellent written and verbal communication skills

How to Stand Out (Preferred Qualifications)

Experience with eCTD Module 5 and Module 2 writing for global marketing authorization applications

Familiarity with Veeva Vault and Please Review

Knowledge of pharmacovigilance documents

Ability to work autonomously and collaboratively in a team environment

Strong organizational and time management skills

Biopharmaceuticals #MedicalWriting #CareerOpportunity #CompetitivePay #RemoteWork

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