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Lead Medical Writer - PSS

Laboratory Corporation of America Holdings (Covance)

Manila, Philippines

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-size: 12pt;">Labcorp are recruiting a Lead Medical Writer to work outsourced to one of our clients.  Candidates can work home based in Manila.  It's key for candidates to have experience of signal detection/<span style="font-family: verdana, geneva; color: black;">aggregate </span>reporting for more than 5 years.</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-size: 12pt;">Role responsibilities will include but not limited to:</span></p><ul><li style="color: #000000;"><span style="font-size: 12pt;">Conducting literature searches for authoring various types of reports.</span></li><li style="color: #000000;"><span style="font-size: 12pt;">Write and review various safety reports (or part of such reports) for global regulatory submissions, including Annual Reports (IND and other), Periodic Safety Update Reports/ Periodic Benefit Risk Evaluation Reports, Periodic Adverse Drug Experience Reports, Bridging reports and other clinical documents as assigned.</span></li><li style="color: #000000;"><span style="font-size: 12pt;">Write Common Technical Document Summaries including Non Clinical and Clinical Overviews, Clinical Summaries and other regulatory documents as assigned.</span></li><li style="color: #000000;"><span style="font-size: 12pt;">Write Investigator Brochures and sections of/entire protocols</span></li><li style="color: #000000;"><span style="font-size: 12pt;">Write Clinical Study Reports (in whole or in part) for Phases 1-4 trials, including full study reports, abbreviated reports, web synopses, subject narratives.</span></li><li style="color: #000000;"><span style="font-size: 12pt;">Author Informed Consent Forms (ICFs), manuscripts, abstracts, posters for conferences.</span></li><li style="color: #000000;"><span style="font-size: 12pt;">Resolve and/or escalate issues in a timely manner.</span></li><li style="color: #000000;"><span style="font-size: 12pt;">Timely escalation of unresolved issues to internal and external (client) point of contact.</span></li><li style="color: #000000;"><span style="font-size: 12pt;">Support and contribute to onboarding, training, mentoring, and coaching of new associates.</span></li><li style="color: #000000;"><span style="font-size: 12pt;">Prepare medical information responses for HCPs.</span></li><li style="color: #000000;"><span style="font-size: 12pt;">Act as a writing coach.</span></li><li style="color: #000000;"><span style="font-size: 12pt;">Coordinate activities related to various types of report writing across a team of writers if applicable.</span></li><li style="color: #000000;"><span style="font-size: 12pt;">Liaise with client and act as a primary point of contact for all report writing activities.</span></li><li style="color: #000000;"><span style="font-size: 12pt;">Perform various support activities such as tracking, maintenance of metrics, performing and documenting quality checks and training.</span></li><li style="color: #000000;"><span style="font-size: 12pt;">Assist in estimation of resource requirement and responding to RFPs as needed.</span></li><li style="color: #000000;"><span style="font-size: 12pt;">Internal and external (client) communication & co-ordination to get the required inputs.</span></li><li style="color: #000000;"><span style="font-size: 12pt;">Get resolution on issues affecting project deliverables.</span></li><li style="color: #000000;"><span style="font-size: 12pt;">Creating and updating labels, , e.g. Core Data Sheets, USPI, centralized SPC’s, Med Guides.</span></li><li style="color: #000000;"><span style="font-size: 12pt;">Search literature databases for relevant information, recommend label changes, author proposed label text and preparation of supporting/justification document.</span></li></ul><p style="margin: 0px;"> </p><h2>Education/Qualifications:</h2><ul><li style="color: #000000;"><span style="font-size: 12pt; font-family: verdana, geneva;">Master’s degree in Pharmacy/related science area</span></li><li style="color: #000000; font-family: 'Calibri',sans-serif; font-size: 11pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Bachelor’s degree in Medical Science</span></li></ul><h2>Experience:</h2><ul><li style="color: #000000;"><span style="font-size: 12pt; font-family: verdana, geneva;">At least 5-8 years’ medical writing experience in the pharmaceutical industry</span></li><li style="color: #000000;"><p style="margin: 0px;"><span style="font-size: 12pt;">Experience of signal detection/<span style="font-family: verdana, geneva;">aggregate</span> reporting for more than 5 years.</span></p></li><li style="color: #000000;"><p style="margin: 0px;"><span style="font-family: verdana, geneva; font-size: 12pt;">Candidates must be able to communicate effectively in the English language.</span></p></li></ul>

Job posted: 2021-12-03

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