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.
The Associate Director of Clinical Editing will ensure the accuracy of content in clinical and regulatory submission documents prepared by Medical Writing in addition to training and supervising clinical editors. This role reports to the Global Head of Clinical Editing.
ROLES AND RESPONSIBILITIES
- Responsible for performing quality reviews and editing clinical documents, regulatory submissions, and other related documents
- Performs detailed data accuracy reviews and fact-checks statements in clinical and regulatory documents, tables, literature summaries, and other internal documents
- Substantively edits and proofreads documents to correct and streamline grammar, spelling, style, and format
- Verifies that document content is consistent with internal, client, and related authority guidelines
- Formats, styles, and troubleshoots functionality and presentation of documents and templates
- Responsible for training, supervising, and mentoring clinical editors. Provides high-quality feedback to ensure proper development of clinical editors.
- Contributes to periodic reviews of the quality control process
- Communicates with medical writers and other team members to ensure the accuracy of documents
- Responsible for inspection-readiness of medical writing activities
SKILLS AND COMPETENCIES
- Excellent language skills (reading, writing, editing, team communication)
- Ability to interpret clinical data and literature
- Ability to follow instructions and apply resourceful insight to problem-solving
- Project management skills
- Ability to communicate with professionals from a variety of backgrounds
- Knowledge of the AMA Manual of Style, other style guides, and any guidelines related to assigned projects
- Expertise in Microsoft Word, including advanced formatting, styles, cross-referencing, bookmarks, and other related skills
- Fluent in English
- Expertise in Microsoft Word and understanding of Acrobat/PDF software
- Experience with Veeva, SharePoint, PerfectIt, and StartingPoint is a plus
EDUCATION, EXPERIENCE, AND QUALIFICATIONS
- College degree or 2+ years of education in a related field
- At least 10 years of related experience in clinical and regulatory document review or medical editing
- Submissions experience (QC of CTD Modules 2 and 5) is preferred
- Experience as a line manager is preferred
- Candidates located in Eastern Standard Time Zone preferred.
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.
If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at hr.us@argenx.com. Only inquiries related to an accommodation request will receive a response.