Senior Medical Writer

Argenx; United States; On-site; USD 128,000 - 176,000; Full time

Benefits offered by this job

Short/long-term incentive programs

Comprehensive benefits package

Job summary

argenx is seeking a Senior Medical Writer to provide regulatory medical writing support for complex clinical, nonclinical, and safety documents for regulatory submissions. You will execute the overall strategy for medical writing processes per argenx standards and corporate objectives, coordinating with cross-functional teams to ensure timely, compliant deliverables.

The ideal candidate has 3+ years of sponsor-level pharma/biotech medical writing experience, native American English, and hands-on

Qualifications

• Bachelor’s degree in a scientific or clinical discipline is required; Ph.D. preferred.
• 3+ years of sponsor-level pharma/biotech medical writing experience required.
• Native or bilingual American English proficiency.
• Experience with Veeva Vault and Please Review.
• Ability to implement lean writing techniques and work autonomously or in a team.

Responsibilities

• Author and project manage content for regulatory submissions to ensure accuracy and compliance.
• Prepare phase 1-4 protocols, master ICFs, IBs, and CSRs.
• Ensure inspection-readiness of medical writing activities.
• Support lead writer and teams to meet deadlines.
• Execute corporate objectives and strategize writing processes.
• Manage multiple deliverables simultaneously.

Skills

American English fluency

Regulatory writing experience

Team collaboration

Time management

MS Office

Communication skills

Education

Bachelor’s degree in science or clinical discipline

PhD preferred

Tools

Veeva Vault

Please Review

Job 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.

We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.

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.

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

For applicants in the United States: 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 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.

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. It also 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.

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.

Before you submit your application, CV or any other personal details to us, please review our argenx Privacy Notice for Job Applicants to learn more about how argenx B.V. and its affiliates (“argenx”) will handle and protect your personal data. If you have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at [e-mail].

If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at [e-mail]. Only inquiries related to an accommodation request will receive a response.