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Capital One
Plano Town Center (31064), United States of America, Plano, TexasSenior Associate, Experience DesignThis is a Hybrid position located in Plano, TX. Relocation to Plano, TX is required if you're not lo...
Jul 20, 2024
Plano, TX
argenx
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 p...
Jul 31, 2024
Dallas, TX
argenx
At argenx, we build our culture from the collective power of the team and the knowledge that together, we are better. We are one team, one culture, with one purpose. As part of that team, the Territor...
Jul 12, 2024
Dallas, TX
argenx
The Field Neurologist is a key member of the Neuromuscular Therapeutic Area within the US Medical Affairs and Evidence Generation Community. S/he is a neurologist/ neuromuscular/neuroimmunology traine...
Jul 13, 2024
Dallas, TX
Doyon Government Group
Payroll Supervisor
Doyon Government Group
Overview: JOB SUMMARY: The Payroll Supervisor is responsible for overseeing and managing the entire payroll process for multiple entities, ensuring timely and accurate submission and processing of pay...
Sep 19, 2024
Dallas, TX
HazTek Safety Management
Safety Specialist/ Manager| Dallas, TX
HazTek Safety Management
Responsibilities The Safety Specialist/Manager supports specific project needs in Dallas, TX area by ensuring best practices are implemented, safety compliance requirements are met, and enhance a cult...
Sep 21, 2024
Dallas, TX
Associate Director, Clinical Editing
Dallas, TX
Jul 31, 2024
fulltime

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.

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Associate Director, Clinical Editing
argenx
Dallas, TX
Jul 31, 2024
fulltime
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