[Hiring] Senior Medical Writer @argenx

Role Description

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.

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.

• 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.

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.
• 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.

Requirements

• 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 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.
• 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.

Company Description

At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.

For applicants requiring reasonable accommodation in completing their application, interviewing, or otherwise participating in the candidate selection process, please contact us at [email protected]. Only inquiries related to an accommodation request will receive a response.