Senior Medical Writer - Regulatory Writing

As a Senior Medical Writer you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Leads a single team which guides medical writing activities within a designated therapeutic or functional area for key response documents and regulatory submissions.
Leads the writing strategy providing expertise including organization, content, timelines, and resource requirements.
Provides more complex advanced input for study designs, analysis plans, sections of INDs and marketing applications
Coordinates the activities, contract employees and vendors (on-site or external), provides review and substantive editing of contributions, and ensures resolution of issues.
Within designated therapeutic or compound function, manages deliverables and preparation of documents for submission to FDA or other regulatory agencies, ensuring consistency of content within therapeutic areas and adherence to regulatory requirements and processes across development programs.
Represents Medical Writing on cross-functional teams and task forces (related to projects, process, and standards).
As required, serves as lead writer for important regulatory response documents and key components of regulatory submissions.
Bachelor's degree in science, health profession, or journalism required.
At least 5+ years' experience writing for pharma or biotechnology required.
Experience writing regulatory strategy documents, specifically Briefing Books and Health Authority responses.
Experience as lead writer for key documents included in major US and/or international regulatory submissions required.
Experience managing writing activities for a major US or international regulatory submission (project or people management) preferred.

Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed product

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.
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
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

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At ICON, diversity, inclusion & belonging are fundamental to our culture and values.
Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities.
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.
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 through the form below.