Sr Medical Copy Editor

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Job description

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

*Who Are You?*

You are an experience professional with a passion for editing. You are organized, but flexible and adaptable to unexpected changes. You can easily envision the bigger picture, without losing sight of the day-to-day tasks. You can provide excellent leadership to not only your project teams, but also to clients. You are excited and enthusiastic. You motivate your teams to do great work and collaborate easily with your clients. Most of all, you want to do it in a place where you're more than an employee number. A place you love working.

Still here? Good. Because if this is you, we'd really like to meet you.

*What will you be doing?*

*Lead Editors* are typically assigned complex projects or other work to support, are expected to perform their responsibilities with considerable independence, coordinate assigned deliverables and guide these across multiple staff members. The Lead Editor will also manage multiple regulatory document projects and be a subject matter expert on document management system processes and procedures pertaining to document creation, review, and approval; responsible for editorial review of documents, checking grammar, style, and usage as defined by company standards; perform quality control (QC) checks of documents against source materials ensuring delivery of accurate and complete work within designated timelines; and responsible for the training, guidance, and mentoring of the editorial junior staff and may oversee vendor deliverables.

*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; act as a liaison with functional area teams to manage workflows and approve documents.

* Responsible for working with and providing oversight for vendors maintaining EndNote reference libraries and researching literature references related to regulatory documents.

* Serves as a technical expert for clinical research teams regarding the regulatory EDMS and regulatory publishing requirements

* Independently plans and executes novel and complex assignments

* Assists Regulatory Operations in developing clinical submission project plans.

*Ensure accuracy of information*

* Has expertise in editing and 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 timeline

*Edit documents*

* Using MS Word, the Lead Editor will edit a variety of documents (eg, 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.

* QC review is an added bonus

* 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.

*What do you need to have?*

*Education and Experience:*

* Bachelor's degree in science or biomedical sciences or journalism/English/communications required.

* Computer skills and expertise in relevant applications (eg, Microsoft Office and Adobe Acrobat).

*Knowledge, Skills, and Abilities:*

* Minimum 5 years of experience in medical editing (preferably pharmaceutical) and expertise with AMA Manual of Style.

* Minimum 3 years writing or editing experience in clinical development environment

* 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

* Demonstrated ability to manage multiple projects

* Expert computer knowledge (eg, MS Word, PowerPoint, Excel, and EndNote) and regulatory electronic document management systems (EDMS; eg, Documentum)

* Demonstrates expertise in editing, QCing, formatting, and finalizing clinical, regulatory, and pharmacovigilance documents

* Has an understanding of clinical research processes

* Has an understanding of regulatory processes

* Has in-depth knowledge of other clinical functional areas

* Strong interpersonal skills and ability to work with team members in a variety of roles

* Excellent organizational and business skills are required

*Benefits of working in ICON*

Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, 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, 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.