Principal Medical Writer

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-size: 12pt;">The Principal Medical Writer is responsible for preparation and coordination of complex clinical study protocols and clinical study reports (CSRs), and other documents as needed.</span></p><p style="margin: 0px;"> </p><ul><li><span style="font-size: 12pt;">Writes and coordinate the development of protocols, CSRs or other clinical documents of any complexity </span></li><li><span style="font-size: 12pt;">Takes the lead in preparing submission level documents</span></li><li><span style="font-size: 12pt;">Act as leader of Medical Writing team on large-scale (multiple document) writing projects, as appropriate, with support from management. Influence teams to adhere to the relevant medical writing requirements for projects </span></li><li><span style="font-size: 12pt;">Produces scientific papers, abstracts and/or posters, and presentations.</span></li><li><span style="font-size: 12pt;">Effectively manage multiple assignments in parallel, ensuring adherence to quality, timelines and budget requirements</span></li><li><span style="font-size: 12pt;">Prepare documents in accordance with <span style="font-family: arial, helvetica, sans-serif;">Labcorp Drug Development</span>/Client Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory/industry guidelines</span></li><li><span style="font-size: 12pt;">Act as medical writing lead and liaison for major clients and partners</span></li><li><span style="font-size: 12pt;">Represent company at scientific and medical writing forums </span></li><li><span style="font-size: 12pt;">Keep up to date with developments in Medical Writing</span></li><li><span style="font-size: 12pt;">Demonstrate detailed knowledge of Medical Writing industry requirements such as ICH and regulatory agency guidelines</span></li><li><span style="font-size: 12pt;">To regularly demonstrate initiative and ability to deal with medical writing situations independently. Present solutions and convince management and teams to adopt recommended strategies</span></li><li><span style="font-size: 12pt;">Lead Medical Writing initiatives to develop and improve processes, including new technologies. Persuade other department staff to accept and embrace new working practices</span></li><li><span style="font-size: 12pt;">Mentor staff and provide guidance and training to department</span></li><li><span style="font-size: 12pt;">Provide support for Business Development opportunities such as time and cost estimates, attendance at client bid defense meetings, industry conferences</span></li><li><span style="font-size: 12pt;">Write and review <span style="font-family: arial, helvetica, sans-serif;">Labcorp Drug Development</span> SOPs and associated documents</span></li><li><span style="font-size: 12pt;">Represent department in audits and inter-department working groups</span></li><li><span style="font-size: 12pt;">Comply with <span style="font-family: arial, helvetica, sans-serif;">Labcorp Drug Development</span> internal processes and procedures</span></li></ul><h2>Education/Qualifications:</h2><p style="margin: 0px;"><span style="font-size: 11.0pt;">Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., PhD or Masters) preferred</span></p><h2>Experience:</h2><ul><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Typically minimum 6 years medical writing experience, including 3 years as medical writing project lead</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Experience with Clinical Study Reports (CSR's)</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Excellent command of written and spoken English</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Excellent written and verbal communication skills</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">In-depth knowledge of MS Word</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Excellent organizational and time management ability</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Excellent knowledge of ICH guidelines applicable to medical writing and other regulatory guidances </span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Excellent understanding of medical/scientific terminology, data analysis and interpretation</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Appreciation of the business requirements of a contract research organization</span></li></ul>