EVMPD Coordinator (Pharma domain Mandate)

Associate / Junior

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{"group":"Organization","title":"EVMPD Coordinator (Pharma domain Mandate)","zohoId":"557706000003379001","endDate":"2020-05-31T00:00:00.000Z","jobType":"Full Time","job_url":"98-orion-innovation-evmpd-coordinator-pharma-domain-mandate","agencyId":1,"location":[{"lat":40.3572976,"lon":-74.6672226,"city":"Princeton","text":"Princeton, NJ 08540, USA","state":"New Jersey","country":"United States","zipCode":"","is_state":false,"is_country":false,"state_code":"NJ","countryCode":"US","isLocationSet":true,"loc_h3_hex_res4":"842a13dffffffff","isLocationResolved":true,"is_address_available_from_parser":true}],"maxSalary":"120000","minSalary":"0","startDate":"2020-04-14T00:00:00.000Z","onBehalfOf":"42","description":"<span id=\"spandesc\"><p style=\"text-align: justify\" class=\"MsoNormal align-justify\"><b>Overview&nbsp;</b></p><ul><li><span lang=\"EN-US\" style=\"\">Division: Research\nand Development / Global Regulatory, Safety and Biometrics / Global Submissions\nRegulatory Policy</span><br /></li><li><span lang=\"EN-US\" style=\"\">Provide\ndata gathering, data entry and data QC support for the xEVMPD (Extended\nEudraVigilance Medicinal Product Dictionary) Operations Group in compliance\nwith EMA’s Article 57(2) Regulation.</span><br /></li><li><span lang=\"EN-US\" style=\"\">Provide tactical and strategic\nsupport for the IDMP / ISO SPOR program by providing subject matter expertise\nand performing data evaluation and remediation activities.&nbsp;</span><br /></li></ul><p class=\"MsoNormal\"><b><span lang=\"EN-US\" style=\"\">Position\nResponsibilities&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</span></b><br /></p><ul><li style=\"text-align: justify\" class=\"align-justify\"><span lang=\"EN-US\" style=\"\">Maintains understanding of the assigned Regulatory Processes</span><br /></li><li style=\"text-align: justify\" class=\"align-justify\"><span lang=\"EN-US\" style=\"\">Manages daily workload and independently addresses questions for assigned\nregulatory processes</span><br /></li><li style=\"text-align: justify\" class=\"align-justify\"><span lang=\"EN-US\" style=\"\">Contributes to enhancements in developed areas of expertise</span><br /></li><li style=\"text-align: justify\" class=\"align-justify\"><span lang=\"EN-US\" style=\"\">Provides support for internal audits, HA inspections and corrective action\nplans</span><br /></li><li style=\"text-align: justify\" class=\"align-justify\"><span lang=\"EN-US\" style=\"\">Supports management in developed areas of expertise</span><br /></li><li style=\"text-align: justify\" class=\"align-justify\"><span lang=\"EN-US\" style=\"\">Recognizes and reports data compliance issues and how they impact assigned\nprocesses</span><br /></li><li style=\"text-align: justify\" class=\"align-justify\"><span lang=\"EN-US\" style=\"\">Executes operational aspects of enabled processes according to Client’s\nprocedures</span><br /></li></ul><div style=\"text-align: justify\" class=\"align-justify\"><br /></div></span><br /><span id=\"spanreq\"><h3>Requirements</h3><ul><li><span style=\"\" lang=\"EN-US\">Demonstrates\nexperience and understanding of the procedures and decision-making process of\nthe Health Authorities.</span><br /></li><li><span style=\"\" lang=\"EN-US\">Strong understanding of regulatory operations</span><br /></li><li><span style=\"\" lang=\"EN-US\">Knowledge and experience with computer systems in an R&amp;D environment</span><br /></li><li><span style=\"\" lang=\"EN-US\">Understanding of system validation, testing methods, GMP guidelines and\nelectronic records regulations</span><br /></li><li><span style=\"\" lang=\"EN-US\">Experience in dealing with internal customers and supervising external\ncontractors</span><br /></li><li><span style=\"\" lang=\"EN-US\">High proficiency with Microsoft suite of products</span><br /></li><li><span style=\"\" lang=\"EN-US\">Excellent command of English language, both written and oral. Strong\npresentation skills.</span><br /></li></ul><div><br /></div></span><br />","isHybridJob":false,"isRemoteJob":false,"noOfOpenings":1,"maxExperience":"8","minExperience":"4","isOnPremiseJob":true,"onBehalfOfName":"Orion Innovation","otherlocations":[],"zohoCurrencyIn":"USD","experienceLevel":"Associate / Junior","zohoNoOfOpenings":{"noOfOpenings":1,"fulfillmentIds":["557706000003379001-1"]},"otherJobReference":null,"sharpenedJobTitle":"EVMPD Coordinator (Pharma domain Mandate)","job_category_group":3,"portalLocationDisplay":"Princeton NJ","expertise_coreskill_or_product":["Other"],"job_id":"2234"}