Medical Writer I-CDS

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-family: verdana, geneva; font-size: 12pt;">The Meical Writer I-CDS will be responsible for independently preparing lower complexity protocols and CSRs including interpretation of clinical data and statistical results as appropriate.</span></p><ul><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: verdana, geneva;">Works with more experienced colleagues in the development of higher complexity protocols and CSRs and other clinical documents as needed.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: verdana, geneva;">Independently prepares and reviews patient safety narratives.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: verdana, geneva;">Provides support and project management of narrative projects.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: verdana, geneva;">Prepares and/or oversees compilation of CSR appendices.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: verdana, geneva;">Prepares documents in accordance with Covance/Client Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory/industry guidelines.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: verdana, geneva;">Independently reviews Statistical Analysis Plan (SAP) and Tables, Listings, and Figures (TLFs) for assigned studies to ensure appropriate data presentation for CSR purposes. Provides feedback on SAP and TLFs to project team as needed. </span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: verdana, geneva;">Incorporates internal and/or external review comments on clinical documents.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: verdana, geneva;">Communicates with internal/external clients as needed to facilitate achievement of project goals.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: verdana, geneva;">Participates in meetings with internal and external clients, with guidance and support from colleagues. </span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: verdana, geneva;">Leads meetings as appropriate.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: verdana, geneva;">Responsible for project coordination and adherence to project timelines and budget, as appropriate.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: verdana, geneva;">Represents department in inter-department working groups.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: verdana, geneva;">Provides training and guidance to Associate Medical Writers and other staff as appropriate.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: verdana, geneva;">Complies with Covance internal processes and procedures.</span></li><li style="margin-left: .25in;"><span style="font-size: 12pt; font-family: verdana, geneva;">Performs other duties as assigned by Management.</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;">1-year medical writing experience or 2 years professionally-related experience </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;">Good 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;">Good organizational and time management ability</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Excellent interpersonal skills</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Scientific or Clinical research experience desirable</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Good scientific writing skills</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Understanding of medical, pharmacokinetic and statistical principles</span></li></ul>