argenx
Associate Director, Medical Writing
This job is now closed
Job Description
- Req#: REQ-3724
Employer Industry: Biopharmaceuticals
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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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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