As a Senior Medical Editor, you will be joining the world's largest and most comprehensive clinical research organization, powered by healthcare intelligence.
The Medical Editor executes medical writing editorial activities for projects in accordance with applicable international regulatory regulations and Sponsor requirements. The Editor manages multiple regulatory document projects and is a subject matter expert on document management system processes and procedures pertaining to document creation, review, and approval. You will be responsible for the editorial review of documents, checking grammar, style, and usage as defined by company standards, and performing quality control (QC) checks of documents against source materials ensuring delivery of accurate and complete work within designated timelines.
What you will be doing:
Ensure accuracy of information
- Has expertise in quality checking to ensure accuracy and consistency within and across documents. Will have functional area responsibility for ensuring that regulatory documents accurately reproduce information contained in source documents and work is completed within designated timelines.
Edit documents
- Using MS Word, the Lead Editor will edit a variety of documents (e.g., clinical study reports, Investigator's Brochures, CTD summary documents, briefing documents). Responsibilities include editing for grammar, style, usage, and consistency with company templates and standards.
Serve as a technical resource
- Expected to manage multiple projects and be a subject matter expert in document management system processes and procedures, which include granular clinical study reports and other regulatory documents.
- Independently plans and executes novel and complex assignments.
Lead change and deliver on commitments
- Manage multiple assignments and make effective decisions regarding competing priorities.
- Show solid judgment and independence while interacting with internal team members and external writers or other personnel; communicate well both within and outside Medical Writing about expectations, roles, responsibilities, and technical details.
- Demonstrate a professional approach in adapting to change and be proactive about expressing ideas and concerns in a respectful manner.
You are:
- Demonstrates expertise in QCing, editing, formatting, and finalizing clinical, regulatory, and pharmacovigilance documents.
- Bachelor's degree in science or biomedical sciences or journalism/English/communications required.
- Computer skills and expertise in relevant applications (e.g., Microsoft Office and Adobe Acrobat).
- Minimum 3 years of experience in medical editing (preferably pharmaceutical) and expertise with AMA Manual of Style.
- Experience with clinical and regulatory documents, ICH guidelines, and document management systems including experience supporting global original IND/NDA/MAA/ROW filings and management of filing review process in the Americas, Europe and ROW.
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 designed to be competitive within each country and focused on well-being and work-life balance opportunities for you and your family.
- Various annual leave entitlements.
- A range of health insurance offerings to suit you and your family's needs.
- Competitive retirement planning offerings to maximize 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 specialized 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, subsidized travel passes, health assessments, among others.
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. We're proud of our diverse workforce and the work we've done to become a more inclusive organization. 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.
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.
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.