Sr Clinical Document Specialist

Overview

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Responsibilities

The Document Specialist contributes to the lifecycle management of clinical study documents, ensuring compliance with regulatory specifications. The Document Specialist supports preparation/compilation of submission-ready clinical study report components, and assists as needed with ensuring that components are processed within the electronic document management system (EDMS) to be made available for Global Regulatory Affairs. The Document Specialist ensures adherence to defined document naming standards, providing subject matter expertise for the EDMS. The role interfaces with relevant R&D departments to ensure consistent practices and procedures, and timely delivery of quality submission-ready documents. Additionally, the Document Specialist may perform internal training/mentoring, as necessary.

Key responsibilities include:

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  Clinical Study Report (CSR) Appendices management

  
  


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  EndNote Library maintenance and literature reference requests

  
  


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  Please Review account access management

  
  


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  Document/Submission Plan preparation (for Publishing)

  
  


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  EDMS tasks, including document uploads and finalization workflows

  
  


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  May provide day-to-day technical support to Medical Writing (MW) and other Clinical end-users, troubleshooting IT, and acting as the first escalation point and subject matter expert for Clinical on shared systems (eg, EDMS, SharePoint, PleaseReview).

  
  

Serve as a technical resource

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  Expected to manage multiple projects and be a subject matter expert in document management system processes and procedures, which include granular clinical study reports and other regulatory documents; act as a liaison with functional area teams to manage workflows and approve documents.

  
  


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  Serves as a technical expert for clinical research teams regarding the regulatory EDMS and regulatory publishing requirements

  
  


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  Independently plans and executes assignments

  
  

The ideal candidate will possess the following key skills/competencies:

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  Advanced computer proficiency expected

  
  


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  Familiarity with SharePoint, preferred

  
  


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  Familiarity with virtual document creation, preferred

  
  


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  Ability to work effectively in a team-oriented environment

  
  


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  Good oral and written communication skills

  
  


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  Strong attention to detail

  
  


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  Ability to work successfully within a cross-functional team

  
  


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  Ability to prioritize resourcing needs during critical project submissions

  
  

Qualifications

Education experience requirements include:

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  Bachelor's degree or related experience is required; scientific and/or computer science field preferred

  
  


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  Experience in the preparation of documents for submission using Regulatory/EDMS, eg, Documentum® ideally including FirstDoc®

  
  


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  Good working knowledge of Adobe Acrobat and Microsoft Word is essential

  
  


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  Working knowledge of the use and maintenance of document templates

  
  


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  Knowledge of requirements for electronic submissions to regulatory authorities and records management required (eg, ICH E6, CFR 21 Part 11)

  
  

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

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Posted Date 6 days ago (11/15/2022 2:37 PM)

ID 2022-97503

Location : Location US-Remote