Senior Medical Writer - North Wales, PA

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.

Senior Medical Writer
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; writing and managing 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 . 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


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