Senior Medical Editor - Home-Based (US/Canada)

As a Senior Medical Editor you will be supporting a global mid-sized biotech company. While being stably employed with ICON, you will be fully embedded with our client. 

The position is home based East Coast USA. Your contribution will be in the field of solid and liquid tumors. While working for our client, you will be able to profit from ICON through continued learning opportunities and building a longer-term career.

This position is responsible for quality control (QC) review of clinical documents intended for submission to health authorities worldwide.  The Senior Medical Editor will copyedit/proofread, format, and verify data content in clinical documents in accordance with SOPs and processes to ensure documents meet required standards, and may oversee the workload for the editors, establishing schedules and interacting with cross-functional authors.  The Senior Medical Editor performs the activities with minimal oversight needed.

What you will be doing:

• Perform QC review of documents (eg, clinical study protocols and amendments, clinical study reports [CSRs], Investigator's Brochures, and Module 2 clinical summary documents) to ensure compliance with the Style Guide and submission standards.
• Verify data in documents against the source tables, figures, and listings and format tables according to standards.
• Copyedit/proofread clinical documents for grammar, style, and formatting according to AMA and companyy's style guides.
• Ensure internal consistency and confirm that data are reported correctly, statements accurately reflect source documents or data (eg, SAS tables and listings).
• Check reference list in documents, including verifying citation information vs PubMed, ordering copies of references and adding to the electronic document management system (EDMS), and ensuring each reference is cross-referenced in the document.
• Proofread documents against the standard templates to ensure compliance with required sections and text.
• Perform publishing of nonclinical and clinical documents and the compilation of required CSR appendices, as needed.

You Are:

• Bachelor’s degree in English, Basic Science, Business, or other analytical field with 4 years related experience in the pharmaceutical industry OR 6+ years of experience in a discipline directly related to document production (eg, medical writing, QC, editing, publishing).
• Strong working knowledge of the editorial and publishing activities within Clinical Development.
• Proficient in Microsoft Word, including the ability to format tables, insert cross-references, apply styles, and use templates.  Experience with PowerPoint, Excel, Visio, Adobe.
• Strong working knowledge of Adobe PDF bookmarking and internal/external hyperlinking to meet submission-ready standards.
• Experience in the use of an EDMS (eg, Veeva Vault or SharePoint).

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

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsICON, 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 or submit a request here.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.