Manager, Regulatory Publishing - Ellicott City, MD

TEAMWORK
The Ultimate Symbiotic Relationship

Focusing on a common goal. Performing your job accurately so that the next person can do theirs. That's how we work together at ICON Clinical Research. Because at ICON, your personal best is the valuable link in the teamwork we need to achieve quality results.

Working with ICON, you'll share in a unique culture of a large company that emphasizes a warm, friendly environment. This is where career possibilities can become realities... where those who look for challenges, embrace the learning and growth opportunities we offer.

ICON Clinical Research is dedicated to providing the pharmaceutical and biotechnology industries with exceptional clinical research and biometrics services, and we're the first international CRO awarded ISO 9001:2000 quality certification across all divisions and functions.

Manager, Regulatory Publishing
Regulatory Affairs Department

Ellicott City, MD
Redwood City, CA

The selected candidate will be responsible for all activities associated with the implementation, preparation and publication of electronic regulatory submissions using software such as CoreDossier and other software, including ISIToolbox, Adobe Acrobat, and MS Word. In this role, your responsibilities will include establishing procedures and systems for publishing documents for paper and fully electronic regulatory submissions; troubleshooting publishing software issues; and working with the Business Development group to prepare proposals and cost estimates for publishing tasks. In this role, you will represent Electronic Publishing on project teams and advise on content and format requirements for clinical reports and other regulatory documents. Additionally, you will evaluate new software publishing solutions as they become available on the market, and interact with FDA and the FDA website for news and updates relating to electronic publishing.

The qualified candidate will have a Bachelor's degree, preferably in the life or biomedical sciences, or extensive electronic publishing experience in the biotechnology or pharmaceutical industry. Medical writing experience is preferred. Must have a minimum of four years experience in electronic publishing of regulatory submissions in a clinical research environment in the biotechnology or pharmaceutical industry. Candidate must also possess demonstrated expertise with grammar, syntax, format, and thorough knowledge of FDA and ICH guideline. Excellent written and oral communication skills, as well as problem-solving ability, strong interpersonal skills, and the ability to plan and organize are required.


Come to ICON and be an important part of a well respected and growing company that believes the details of your career are every bit as critical as the work you do. You'll enjoy highly competitive benefits in addition to flexible scheduling, relocation assistance, tuition reimbursement, credit union, health club privileges, and many other exceptional advantages.

TO APPLY and for more information on our opportunities and locations, please visit us at http://www.iconclinical.com/index.asp?getpage=true&sid=10 . No agencies, please.

ICON. We are the right solution.

ICON Clinical Research is an Equal Opportunity Employer committed to strength in diversity.

www.iconclinical.com

To Apply for this position, please CLICK HERE