Principal Medical Writer

As a Principal Medical Writer you will be responsible For the expansion of our team, argenx is looking for a Medical Writer, who will be
responsible for providing medical writing support for the development of complex clinical
documents for regulatory submissions including, but not limited to clinical protocols,
informed consents (ICFs), clinical study reports (CSRs), investigator brochures (IBs), patient
narratives, annual reports, and other key clinical and regulatory documents.
This individual will support the overall strategy for all medical writing processes according
to client standards.

What you will be doing:

The position will have the following key responsibilities:
• Support the clinical medical writing team, in developing content for a variety of
clinical regulatory documents, including clinical protocols, informed consents (ICFs),
clinical study reports (CSRs), investigator brochures (IBs), safety narratives, and
eCTD modules
• Draft and manage documents that are well-organized, accurate, consistent, and
comply with applicable company SOPs and regulations
• Ensures all clinical documents are standardized according to the argenx style guide
and are based on company-approved document templates to ensure quality and
consistency of the portfolio
• Partner with Quality Assurance (QA) during an audit of clinical trial documents to
ensure timely response to findings
• Collaborate with members of clinical trial teams and other functions within medical
writing to ensure project deadlines are met by providing content development
support, research, and editing functions for each program
• Ensure proper development and coaching of junior writers

You are:

Bachelor’s degree in a scientific, medical or clinical discipline or related field
required, PhD preferred
• Native English speaker preferred
• Minimum of 5-7 years of pharmaceutical/biotechnology-related medical writing
experience required
• Knowledge of all FDA and ICH guidelines for clinical reporting required
• eCTD development, publishing, and submission experience preferred
• Biologic writing experience preferred
• Basic understanding of drug development, including the phases, processes, and
techniques used within a clinical development environment from protocol design
through regulatory submission
• Ability to understand FDA/international regulations, ICH guidelines, and applicable
US/international regulatory processes related to document preparation and
production (including CTDs)
• 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 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
• Experience in electronic publishing format preferred


Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.