New · posted Nov 1
argenx · Biotechnology
Director of Medical Writing
- Remote, US
- Remote
- Full-time
- Director
The role
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.
argenx is a clinical-stage biopharmaceutical company creating and developing a pipeline of differentiated antibody therapeutics. Our unique antibody engineering technologies combined with the complementary expertise of our people enabled us to build a clinical-stage portfolio of novel product candidates – tailored from discovery through development to address patient needs.
For the expansion of our team, argenx is looking for a Director of Medical Writing to manage medical writers and author content. This individual will also develop critical infrastructure for the maturation of the department.
This individual will contribute to the development and execution of the overall strategy for all medical writing processes according to argenx medical writing standards and corporate objectives.
What you need
Desired Skills and Experiencenice to have
Bachelor’s degree in a scientific or clinical discipline or related field required; Ph.D. preferred
Minimum of 7 years of related, sponsor-level pharma or biotech clinical/regulatory medical writing experience required; CRO experience considered
Native/bilingual or fluent American English proficiency
Can provide solutions in creative, effective, and constructive ways
eCTD Module 5 and Module 2 writing experience for global MAAs
Understands the interrelationships of various disciplines within the organization and can effectively navigate
Solution-focused and experience leading teams
Has managed direct reports (overseeing contract medical writers may be considered)
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
Knowledgeable in the regulatory guidances developed for documents authored by medical writing
Ability to proofread documents for compliance with internal and external guidance documents
Ability to approach issues from various perspectives and accurately summarize data to draw a conclusion
Ability to work precisely according to procedures and regulations
Excellent written and verbal communication skills
Ability to prioritize and multi-task successfully in a fast-paced environment
Ability to work autonomously, as well as collaboratively in a team
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 $212,000.00 - $291,500.00 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.
What you'll do
Roles and Responsibilities
Managing focus o Manage (80%) medical writers (in-house FTEs, contractors, and external vendors) who are individually contributing to the MW activities for a variety of regulatory documents
o Author (20%) content and project manage SME contribution to develop content for regulatory submissions that is well-organized, consistent, accurate, and compliant with argenx MW standards, company SOPs, style guide, lexicon, templates, and libraries
Writing focus
Primary author of phase 1-4 protocols, IBs, CSRs, master ICFs, eCTD modules for INDs and BLAs, briefing documents for scientific advice, specialty regulatory documents like PIPs, ODDs, aggregate reports, RFIs, and other documents required for drug development
Engages relevant SMEs and document owners to develop content that is well-organized, consistent, accurate, and appropriate for a regulatory audience
Responsible for inspection-readiness of medical writing activities
Facilitates standardization of documents using document templates, lexicons, and argenx style guide to ensure the quality and consistency of documents across programs
Collaborates with project teams to ensure project deadlines are met by providing content development support, research, and editing functions for each program
Responsible for inspection-readiness of medical writing activities
Mentors less experienced medical writers and develops and implements training to support medical writers and cross-functional teams
Contributes to the development of departmental strategy(ies)
Participates in the development of corporate objectives, goals, measures, and strategies
Ensures direct reports are executing corporate objectives, goals, measures, and strategies
Directs activities of multifunctional projects and reconciles multiple stakeholder views
Capable of working on multiple deliverables simultaneously
Responsible for medical writers assigned to support the medical writing activities for a particular project
Resolves complex issues in which situational or data analyses require in-depth evaluation of variable factors
Determines methods and procedures for assignments
May include roles that are key technical or subject matter experts providing professional or thought leadership
Looks beyond existing methodologies and own discipline to define and resolve complex problems in areas critical to achieving objectives
Pay and benefits
$212,000 – $291,500 a year
Employer providedShort-term incentive program
Long-term incentive program
Retirement savings plans
Health benefits
Equal opportunity, accessibility and legal noticesargenx's statements, word for word
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 [email protected].
If you require reasonable accommodation in completing your 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.
Job intelligence
The context around this role
Live data · November 1, 2026
Salary intelligence
How the pay compares
This role's midpoint is 20% above the US median for Clinical Evaluation & Medical Writing roles at this level.
This roleEmployer provided
Director roles in the US12 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $212,000 | — | $291,500 |
| All US (middle half) | $195,000 | $210,000 | $232,750 |
This role: argenx's own published range. Comparisons: the base pay employers published on open Clinical Evaluation & Medical Writing roles at the same level on Regulatory Jobs, November 1, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Evaluation & Medical Writing
The general path across 39 open Clinical Evaluation & Medical Writing roles on Regulatory Jobs, with the titles they carry most. Not argenx's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 45 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs18
- Collaboration and leadership8
- GMP and compliance4
- Lab testing and methods3
- Clinical trial conduct3
- Regulatory submissions2
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
argenx on Regulatory Jobs
- 7
- Open roles
- 7
- Distinct roles
- 1
- Locations
By discipline
- Clinical4 57%
- Regulatory3 43%
By level
- Director4 57%
- Senior & Principal2 29%
- VP & Executive1 14%
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Director of Medical Writing at argenx
Open until filled. $212K–$292K a year, employer provided.