Senior Medical Writer

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Clinical/Regulatory Medical Writer

Elevating Patient Lives Through Precise Medical Communication

Are you a seasoned medical writing professional passionate about translating complex scientific and clinical data into clear, compliant regulatory documents? Join our dynamic team dedicated to transforming the lives of patients suffering from severe autoimmune diseases.

Your Impact

As a Clinical/Regulatory Medical Writer, you will play a vital role in our mission by:

• Leading the authoring and development of essential clinical, nonclinical, and safety documents critical for regulatory submissions globally.

• Serving as a lead author and project manager, expertly guiding Subject Matter Expert (SME) contributions to craft high-quality, accurate, and cohesive content.

• Authoring a range of key regulatory documents, including Phase 1-4 protocols, Master Informed Consent Forms (ICFs), Investigator Brochures (IBs), and Clinical Study Reports (CSRs).

• Ensuring all medical writing deliverables are fully compliant with argenx standards (style guides, lexicon, templates) and are consistently inspection-ready.

• Collaborating closely with lead writers and cross-functional project teams, driving tasks forward to meet critical project deadlines.

• Skillfully managing and advancing multiple writing projects concurrently in a dynamic environment.

What You’ll Bring

We are looking for a candidate who possesses:

• A Bachelor’s degree in a scientific or clinical discipline or related field is required; a Ph.D. is preferred.

• A minimum of 3 years of relevant, sponsor-level pharma or biotech clinical/regulatory medical writing experience is essential. Experience gained at a CRO will also be considered.

• Native/bilingual or fluent American English proficiency.

• A solution-focused mindset, adept at navigating complex challenges.

• Hands-on experience with document management systems like Veeva Vault and Please Review.

• Experience implementing lean writing techniques.

• A strong understanding of scientific methodology as applied to drug development, including the phases, processes, and techniques used in a clinical development environment from protocol design through regulatory submission.

• Familiarity with pharmacovigilance guidelines and the development of aggregate reports.

• Exceptional attention to detail and the ability to work precisely according to procedures and regulations.

• Proven ability to prioritize, manage time effectively, and successfully multi-task in a fast-paced environment.

• Ability to thrive working both autonomously and as a collaborative team member.

• Excellent written and verbal communication skills.

• Proficiency in MS Office Suite is required.

About argenx

At argenx, we are a global immunology company dedicated to significantly improving the lives of people suffering from severe autoimmune diseases. Our mission is powered by innovation and a deep commitment to patients.

Through our robust pipeline of first-in-class therapies, notably VYVGART®, we are rapidly progressing towards our ambitious 2030 goal: to positively impact the lives of 50,000 patients and fundamentally transform the landscape of autoimmune treatment.

Joining argenx means engaging in meaningful work and discovering endless opportunities for growth, creating truly once-in-a-career experiences as part of our global team located in Belgium, Boston, Japan, and Amsterdam.

Ready to Make an Impact?

If you are a skilled Medical Writer looking to contribute to groundbreaking therapies and grow your career in a vibrant, patient-focused environment, we encourage you to apply. Click the ‘Apply’ button to learn more about this opportunity and submit your application.

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