Senior Medical Writer

🔥 14 hours ago

🇺🇸 United States – Remote

💵 $128k - $176k / year

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

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argenx

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2008

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

argenx is a biotechnology company committed to improving the lives of patients through immunology innovation. The company focuses on developing novel antibody-based therapies to treat severe autoimmune diseases. Using a collaborative approach with pioneering scientists and academic partners, argenx accelerates the discovery of therapeutic antibodies that target specific disease pathways. The company's proprietary products, such as efgartigimod, are aimed at treating diseases where IgG antibodies are pathogenic. Argenx emphasizes innovation, science of collaboration, and patient-centric approaches in its mission to deliver life-changing medical solutions.

📋 Description

• Provide medical writing support for developing complex clinical, nonclinical, and safety documents for regulatory submissions • 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 • Ensure content is well-organized, consistent, accurate, and compliant with argenx Medical Writing standards, including style guide, lexicon, templates, and libraries • 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 ensure project deadlines are met • Execute corporate objectives, goals, measures, and strategies • Work on multiple deliverables simultaneously

🎯 Requirements

• 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 • 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

🏖️ Benefits

• Short-term incentive programs • Long-term incentive programs • Retirement savings plans • Health benefits • Comprehensive benefits package