argenx
Associate Director, Medical Writing
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Job Description
- Req#: REQ-4177
Employer Industry: Biopharmaceutical
Why consider this job opportunity:
- Salary up to $225,500
- Opportunity to participate in short-term and long-term incentive programs
- Comprehensive benefits package, including retirement savings plans and health benefits
- Work in an inclusive and diverse environment
- Chance to contribute to innovative medical writing for drug development
What to Expect (Job Responsibilities):
- Serve as the primary author of clinical documents including protocols, IBs, and CSRs for regulatory submissions
- Engage with subject matter experts to produce high-quality, accurate content tailored for regulatory audiences
- Ensure inspection-readiness of all medical writing activities
- Standardize documents using templates and style guides to maintain quality across projects
- Manage and oversee medical writers and external vendors contributing to regulatory document preparation
What is Required (Qualifications):
- Bachelor’s degree in a scientific or clinical discipline; PhD preferred
- Minimum of 5 years of clinical/regulatory medical writing experience in pharma or biotech
- Fluent in American English
- Basic understanding of scientific methodology in drug development
- Proficiency in MS Office and familiarity with eCTD writing
How to Stand Out (Preferred Qualifications):
- Experience with eCTD Module 5 and Module 2 writing for global marketing applications
- Familiarity with Veeva Vault and pharmacovigilance documents
- Solution-focused approach to challenges in medical writing
- Proven ability to work autonomously and collaboratively in a team setting
#Biopharmaceutical #MedicalWriting #CareerOpportunity #CompetitivePay #InclusiveWorkplace
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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.About the company
We’re a global immunology company using co-creation to develop potential therapies for people with severe autoimmune diseases and cancer.
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