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Lead Medical Writer

Laboratory Corporation of America Holdings (Covance)

Brazil

<h2>Job Overview:</h2><ul><li style="color: black;"><span style="color: black; font-family: arial, helvetica, sans-serif; font-size: 12pt;">Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables </span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="color: black; font-family: arial, helvetica, sans-serif; font-size: 12pt;">Ensure compliance of operations with governing regulatory requirements </span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="color: black; font-family: arial, helvetica, sans-serif; font-size: 12pt;">Create, maintain and assume accountability for a culture of high customer service </span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="color: black; font-family: arial, helvetica, sans-serif; font-size: 12pt;">Efficiency in conducting literature searches for authoring various types of reports </span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="color: black; font-family: arial, helvetica, sans-serif; font-size: 12pt;">Write and review various safety reports (or part of such reports) for global regulatory submissions for Sciformix’s clients, 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: black; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="color: black; font-family: arial, helvetica, sans-serif; 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: black; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="color: black; font-family: arial, helvetica, sans-serif; font-size: 12pt;">Write Investigator Brochures and sections of/entire protocols </span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="color: black; font-family: arial, helvetica, sans-serif; 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: black; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="color: black; font-family: arial, helvetica, sans-serif; font-size: 12pt;">Author Informed Consent Forms (ICFs), manuscripts, abstracts, posters for conferences. </span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="color: black; font-family: arial, helvetica, sans-serif; font-size: 12pt;">Resolve and/or escalate issues in a timely manner </span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="color: black; font-family: arial, helvetica, sans-serif; font-size: 12pt;">Timely escalation of unresolved issues to internal and external (client) point of contact </span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="color: black; font-family: arial, helvetica, sans-serif; font-size: 12pt;">Support and contribute to onboarding, training, mentoring, and coaching of new associates </span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="color: black; font-family: arial, helvetica, sans-serif; font-size: 12pt;">Prepare medical information responses for HCPs </span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="color: black; font-family: arial, helvetica, sans-serif; font-size: 12pt;">Act as a writing coach </span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="color: black; font-family: arial, helvetica, sans-serif; font-size: 12pt;">Coordinate activities related to various types of report writing across a team of writers if applicable </span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="color: black; font-family: arial, helvetica, sans-serif; font-size: 12pt;">Liaise with client and act as a primary point of contact for all report writing activities </span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="color: black; font-family: arial, helvetica, sans-serif; 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: black; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="color: black; font-family: arial, helvetica, sans-serif; font-size: 12pt;">Assist in estimation of resource requirement and responding to RFPs as needed </span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="color: black; font-family: arial, helvetica, sans-serif; font-size: 12pt;">Internal and external (client) communication & co-ordination to get the required inputs </span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="color: black; font-family: arial, helvetica, sans-serif; font-size: 12pt;">Get resolution on issues affecting project deliverables </span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="color: black; font-family: arial, helvetica, sans-serif; font-size: 12pt;">Creating and updating labels, , e.g. Core Data Sheets, USPI, centralized SPC’s, Med Guides </span></li><li style="color: black; font-family: 'Times New Roman',serif; font-size: 12pt;"><span style="color: black; font-family: arial, helvetica, sans-serif; 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><table style="margin: auto auto auto -5.4pt; border: currentColor; border-collapse: collapse;"><tbody><tr><td style="padding: 0in 5.4pt; border: 0px #000000; width: 377.3pt;" width="479"> </td></tr></tbody></table><p style="margin: 0in 0in 8pt;"> </p><h2>Education/Qualifications:</h2><ul><li style="color: #000000;">Master’s degree in Pharmacy/related science area</li><li style="color: #000000; font-family: 'Calibri',sans-serif; font-size: 11pt;">Bachelor’s degree in Medical Science</li><li style="color: #000000; font-family: 'Calibri',sans-serif; font-size: 11pt;">At least 5-7 years’ experience in the pharmaceutical industry, with at least 4 years of it in medical writing</li><li style="color: #000000; font-family: 'Calibri',sans-serif; font-size: 11pt;"><span style="font-family: 'Calibri',sans-serif; font-size: 11pt;">Experience in drug discovery and pharmacovigilance is desirable</span></li></ul><h2>Experience:</h2><ul><li>At least 5-7 years’ experience in the pharmaceutical industry, with at least 4 years of it in medical writing</li><li><p style="margin: 0in 0in 0pt;"><span style="font-family: 'Times New Roman',serif; font-size: 12pt;"> </span><span style="color: black; font-family: 'Times New Roman',serif;"><span style="font-size: 12pt;">Experience in drug discovery and pharmacovigilance is desirable</span> </span></p></li><li><span style="color: black; font-family: 'Times New Roman',serif;"><span style="font-size: 12pt;">Fluent English</span></span></li></ul>

Job posted: 2022-01-13

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