Senior Medical Writer

As a Senior Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Senior Medical Writer 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 company's standards. Senior Medical Writer formulates writing strategy for assigned regulatory submissions or key projects (e.g. response documents)

What you will be doing:

• 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
  Ensure 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

You are:

Minimum of 3-5 years of pharmaceutical/biotechnology-related medical writing experience required

Regulatory papers writing experience

Bachelor’s degree in a scientific, medical or clinical discipline or related field required, PhD preferred
Knowledge of all FDA and ICH guidelines for clinical reporting required

Basic understanding of drug development, including the phases, processes, and
techniques used within a clinical development environment from protocol design
through regulatory submission

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.