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Principal Medical Writer

Principal Medical Writer This is a rare opportunity to join our friendly global MedicalWriting team which sits within ICON's Clinical Research Services group. Our remit is to produce high quality documentssupporting Phase I-III clinical studies and regulatory submissions. Our key department values are:  Passionate about partnership Quality without compromise Flexibility in a dynamic environment  We have an opening for aPrincipalMedical Writer. In this role you will have the followingresponsibilities:  Preparation and QC of clinical and regulatory documents including protocols, clinical studyreports, narratives and safetyreports. This includes: Working with internal study teams to determine/clarify project requirements and obtaining necessary information. Tracking and recording progress against contracted hours/budget using financial tracking tools and the department's project database. Early flagging to management of projects not on track and facilitation of the Change Order process. Attendance at internal and external projects meetings in person or via teleconference. Writing of documents according to agreed contractual obligations and timelines using client or ICON templates and style guides, and adhering to regulatory or other guidance. Incorporation of review comments from internal and external reviewers, including management of multiple sets of comments. Perform QC of documents written by other writers. Oversight of aportfolioof clients. This includes: Participate in all aspects of new business activities eg Input into Requests for Information, proposals and attendance at bid defense meetings in person or via teleconference. Liaison with assigned clients throughout the lifecycle of a project or programme of projects to establish requirements and processes, monitor quality and capitalize on business development opportunities. Provide scientific and technical guidance to the client and Medical Writers. Participation in internal and external audits. To keep Medical Writing senior management informed of project status and any issues that affect document quality, timelines, and adherence to contractual obligations. Training and mentoring of junior Medical Writers. General operational assistance to the Medical Writing team. Preparation and QC of other ad hoc document types, if required. Active participation in department initiatives and process improvements. Participate in development of new writing services. Compliance with department systems, e.g., project database, timesheets, training. Achievement of individual utilization (billability) target. Any other task deemed reasonable by department senior management.   Skills & experience required:Essential: Bachelor's degree in a life science, or equivalent. At least 6 years of experience as a clinical/regulatory Medical Writer. Complete understanding of medical writing operational procedures. Extensive knowledge of scientific and regulatory requirements for clinical trials. Able to assimilate and summarize large volumes of scientific data accurately, clearly and concisely. Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat and Outlook. Able to rapidly learn to use bespoke in-house and client toolbars. Excellent attention to detail. Fluent English (written and verbal).  Preferred: Experience of working for a large CRO. Familiarity with Veeva Vault, Salesforce and Box. Reference: 054215
Salary Range: NA
Minimum Qualification
5 - 7 years

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