Principal Medical Writer

Overview

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

You will Lead, manage, and coordinate all internal and external writing activities associated with the preparation, compilation, and submission of applications to regulatory authorities globally.

Responsibilities

What you will be doing:

• Develop regulatory documents for submission to regulatory agencies globally, including Clinical Study Reports, Clinical Summaries of Efficacy and Safety, and Clinical Overviews, in accordance with ICH and other global guidelines, standards and processes, and Incyte authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.
• Manage medical writing projects, including developing timelines (working with the study/project teams, as necessary) and communication with cross-functional team members to maintain awareness of review cycles and expectations.
• Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.
• Review other documents associated with the assigned project(s) (eg, Protocols and Statistical Analysis Plans), as appropriate.

Qualifications

You are:

- A Bachelor's degree in a life science discipline, with Master's degree in life sciencediscipline preferred. • At least 6 years of medical writing experience in the biopharmaceutical/CRO industry required.

- Regulatory writing experience - Clinical Study Reports, IBs, Protocols

- Oncology experience would be a plus• Proficient understanding and knowledge of domestic and international regulatoryrequirements required and knowledge of therapeutic areas in all phases of clinicaldevelopment desired. • Proficiency in organizing and communicating clinical information necessary. • Strong communications, organizational, time management, and project managementskills are required.

What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.