For the expansion of our team, argenx is looking for a Senior Medical Writer who will provide medical writing support for developing complex clinical, nonclinical, and safety documents for regulatory submissions.
This individual will execute the overall strategy for all medical writing processes according to argenx medical writing standards and corporate objectives.
Key Accountabilities/Responsibilities:
- Author and project manage SME contribution to develop content for regulatory submissions that is well-organized, consistent, accurate, and compliant with argenx Medical Writing standards, including style guide, lexicon, templates, and libraries
- Authors content for phase 1-4 protocols, master ICFs, IBs, and CSRs
- Responsible for inspection-readiness of medical writing activities
- Supports the lead writer and project teams to ensure project deadlines are met
- Executes corporate objectives, goals, measures, and strategies
- Capable of working on multiple deliverables simultaneously
Desired Skills and Experience:
- Bachelor's degree in a scientific or clinical discipline or related field is required; Ph.D. preferred
- Minimum of 3 years of related, sponsor-level pharma or biotech clinical/regulatory medical writing experience required; CRO experience considered
- Native/bilingual or fluent American English proficiency
- Solution-focused
- Experience with Veeva Vault and Please Review
- Experience with implementing lean writing techniques
- Basic understanding of scientific methodology as applied to drug development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission
- Familiarity with pharmacovigilance guidelines and developing aggregate reports
- Ability to work precisely according to procedures and regulations
- Ability to prioritize and multi-task successfully in a fast-paced environment
- Ability to work autonomously, as well as in a team
- Excellent written and verbal communication skills
- Excellent time management skills and a proven ability to work on multiple projects at any given time
- Must be proficient in MS Office
For applicants in the United States: The annual base salary hiring range for this position is $128,000.00 - $176,000.00 USD. This range reflects our good faith estimate at the time of posting. Individual compensation is determined using objective, inclusive, and job-related criteria such as relevant experience, skills, demonstrated competencies and internal equity. This means actual pay may differ from the posted range when justified by these factors. Because market conditions evolve, pay ranges are reviewed regularly and may be adjusted to remain aligned with external benchmarks.
This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies. It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines.
