Senior Medical Writer

About the role

argenx is expanding its team to support the development of medicines for autoimmune patients. We are seeking a Senior Medical Writer to provide medical writing support for regulatory submissions.

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.
• Develop content for phase 1-4 protocols, master ICFs, IBs, and CSRs.
• Support the lead writer and project teams to ensure project deadlines are met.
• Execute corporate objectives, goals, measures, and strategies.
• Capable of working on multiple deliverables simultaneously.

Qualifications

• 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.
• Familiarity with pharmacovigilance guidelines and developing aggregate reports.
• Basic understanding of scientific methodology as applied to drug development.
• 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.

Desired Skills And Experience

• Proficient in MS Office.

Pay

The annual base salary hiring range for this position is $104,000.00 - $143,000.00 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.