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 We candidate privacy and champion equal‑opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately. We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top‑tier employer. #J-18808-Ljbffr