Quality Assurance Specialist, Medical Communications
PhD
Description
<p><b>When our values align, there's no limit to what we can achieve.</b><br /> <br />At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.</p><p>Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.</p><p></p><p></p><p><b>Responsibilities:</b></p><ul><li>Cross check scientific information against cited references and ensure medical accuracy (fact check); ensure consistency with product label where applicable; and verify presence of essential information</li><li>Correct interpretation of scientific data from reference/sources, alignment/formatting of content as per style guides/journal guidelines/congress guidelines</li><li>Ensure consistency of scientific content across different sections (including text, figures, tables) accurate bibliography/in-text citation and alignment of figures/graphs as per branding guidelines</li><li>Confirm that every sentence is source annotated, and each source annotation matches with respective reference and vice versa</li><li>Ensure that information is presented in a neutral manner without any interpretations and/or author’s conclusion</li><li>Track work and communicate with client team on job reviews, prioritization etc., through emails and teleconferencing if needed</li><li>Participate in meetings, as required, to liaise with client stakeholders and resolve partially accepted or rejected comments after discussing with key stakeholders (med affairs lead, regulatory etc.)</li><li>Participate in assigned training programs and work on assignments as per requirement</li><li>Adherence to quality, timelines, confidentiality and security compliance</li></ul><p></p><p><b>Requirements:</b></p><ul><li>Experienced Medical Writer (1-2 years), with a scientific background and degree (PharmD, MD, PhD or Masters), with knowledge of IT and digital solutions.</li><li>Strong attention to detail and accuracy, ability to manage and prioritize multiple, detailed activities, results-orientated with fast and focused execution.</li><li>Good communication, coordination and time management skills.</li><li>Ability to work within a team or across multiple teams (including remotely) as well as independently.</li><li>Fluent in oral and written English with high level of communication skills, and values teamwork, collaboration, and innovation.</li><li>Prior experience working in any of the therapeutic areas of Cardiovascular Renal Metabolism (CRM), Respiratory, Inflammation, Immunology, Oncology would be advantageous</li></ul><p></p>
Pipeline
Olaparib tabletsN/A
Observational Study of Characteristics, Treatment and Outcomes With Severe Asthma in the United StatN/A
NoneN/A
DeflazacortN/A
T790M Mutation Positive 2nd Line STandard of cAre RegistryN/A