Sr Medical Writer, (Contract)North Wales, PA

We work together to find a better way and break new ground to make progress possible. Focused on common goals, we raise the standard and make a difference. We strive for excellence in everything we do. At ICON, career possibilities can become realities for those who look for challenges and embrace learning and growth opportunities. ICON Clinical Research is dedicated to providing the pharmaceutical and biotechnology industries with exceptional clinical research and biometrics services. Join us in one of our current openings and enjoy highly competitive benefits and exceptional advantages. Senior Medical Writer (Contract) Medical Affairs North Wales, PA The successful candidate will independently compile, write, and edit medical documents and reports as well as direct and assist other medical writers in the writing, editing, and compilation of these documents that are components of clinical/regulatory marketing approval applications for new biologics, drugs, or devices. Responsibilities include representing Medical Writing on project teams, and advising on content and format requirements for clinical reports and on regulatory documents; performing quality control review of documents and assessing whether specific project-related documents comply with regulatory requirements, client requests, and ICON SOPs; collaboration in writing NDA, PMA, PLA, IDE, and IND documents (both pre-clinical and clinical reports of clinical studies); and preparing clinical trial protocols, investigator brochures, SAE narratives and periodic safety update reports. The qualified candidate will have five or more years of experience within clinical research, including medical and regulatory writing/editing, and management or oversight experience in medical writing in a CRO or the pharmaceutical industry. An advanced degree in the life sciences is preferred. Other considerations include demonstrated expertise with grammar, syntax, and format. The candidate must have excellent written and oral communication skills, as well as demonstrated problem-solving ability, strong interpersonal skills, ability to plan/organize, and management skills. 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 or send an updated resume to julie.siciliano@iconplc.com No agencies, please. ICON. A Symbol of Excellence. ICON Clinical Research is an Equal Opportunity Employer committed to strength in diversity. To Apply for this position, please CLICK HERE