Senior Medical Writer
argenx
Summary
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.
Job description
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
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
- 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
Benefits
- Retirement savings plans
- Health benefits
- Short-term incentive programs
- Long-term incentive programs
Company overview
argenx is a global immunology company committed to improving the lives of people living with severe autoimmune diseases. Founded in 2008 and headquartered in Amsterdam, Netherlands with major operations in Boston, Massachusetts, argenx is a commercial-stage, fully-integrated biopharma company developing a deep pipeline of differentiated antibody-based therapies. The company's core innovation engine is its Immunology Innovation Program (IIP), which partners with leading academic researchers to translate immunology breakthroughs into novel medicines. argenx has developed and commercialized VYVGART, the first approved FcRn blocker available in more than 30 countries for conditions like generalized myasthenia gravis (gMG), chronic inflammatory demyelinating polyneuropathy (CIDP), and immune thrombocytopenia (ITP). The company leverages its proprietary SIMPLE ANTIBODY™ platform technology based on llama immune systems to access novel disease biology targets, combined with antibody engineering technologies like NHANCE™ and ABDEG™ to enhance therapeutic properties. With over 1,500 employees globally and listed on both Euronext Brussels and Nasdaq, argenx maintains a robust pipeline including empasiprubart (C2 inhibitor) in Phase 3 trials and several earlier-stage experimental medicines targeting various autoimmune conditions.