Senior Medical Writer
Skills
About the role
This is a senior medical writing role at argenx, a global biopharmaceutical company, supporting clinical, nonclinical and safety documents for regulatory submissions. It suits an experienced medical writer who can author and project-manage content across phase 1-4 protocols, informed consent forms, investigator brochures and clinical study reports. The role is open to applicants in the United States.
What you’ll do
- Author and project manage SME contributions for regulatory submission content
- 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 meet deadlines
- Execute corporate medical writing objectives, goals and strategies
- Work on multiple deliverables simultaneously
What they’re looking for
- Bachelor's degree in a scientific or clinical discipline required
- Minimum 3 years of sponsor-level pharma or biotech clinical/regulatory medical writing experience; CRO experience considered
- Native/bilingual or fluent American English proficiency
- Experience with Veeva Vault and Please Review
- Experience implementing lean writing techniques
- Basic understanding of drug development phases and clinical trial processes
- Familiarity with pharmacovigilance guidelines and aggregate reports
- Excellent written and verbal communication skills
- Proficiency in MS Office
Nice to have
- Ph.D. in a scientific or clinical discipline
What’s on offer
- Annual base salary of $104,000-$143,000 USD
- Eligible for short-term and long-term incentive programs
- Comprehensive benefits including retirement savings plans and health benefits
Questions about this role
How much does it pay?
The annual base salary range is $104,000 to $143,000 USD.
How many years of experience do I need?
A minimum of 3 years of sponsor-level pharma or biotech clinical/regulatory medical writing experience.
Do I need a degree?
A bachelor's degree in a scientific or clinical discipline is required; a Ph.D. is preferred.
Is this role remote?
The posting is open to applicants in the United States, with pay tied to US-based hiring.
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