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.

This Senior Medical Writer  is responsible for the development of clinical documents for worldwide submissions to regulatory authorities. The Senior Medical Writer may be responsible for the medical writing activities for one or more compounds and may contribute to major submissions.  

What you will be doing:

• Works directly with multidisciplinary project team members with the goal of independently writing scientifically valid, complete, and consistent documents, such as clinical study reports (CSRs), investigator’s brochures (IBs), and select clinical Module 2 summary documents. 
• Develop regulatory documents for submission to regulatory agencies globally, in accordance with global guidelines, standards and processes, and AMA Medical Writing styles, as applicable, in adherence with study/project timelines and corporate objectives.
• Actively participate in study and/or project team meetings to provide input regarding medical writing deliverables, timelines and any processes needed for the completion of regulatory documents.
• Administrate as appropriate, the receipt, collation, and incorporation of review comments needed for the completion of regulatory documents.
• Review other documents associated with the assigned project(s) (eg, Protocols and Statistical Analysis Plans), as appropriate.

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You are:

- A Bachelor's degree in a life science discipline, with Master's degree in life science
discipline preferred.
• At least 4 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 regulatory
requirements required and knowledge of therapeutic areas in all phases of clinical
development desired.
• Proficiency in organizing and communicating clinical information necessary.
• Strong communications, organizational, time management, and project management
skills 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.