Medical Writer (GPV)

Northbrook, IL 60062

Posted: 11/29/2018 Employment Type: Contract Industry: Other Area(s) Job Number: 23301
  •   Create and maintain the Global periodics schedule by interfacing with external departments. 
  •   Work with affiliates and local health authorities to understand periodic reporting requirements. 
  •   Negotiate with local health authorities to leverage existing reports and periodicities to meet the periodic reporting requirements 
  •   Regularly work with EU-Regulatory Affairs to update and maintain the global periodics schedule 
  •   Coordinate periodic schedule information from multiple sources 
  •   Project management for Aggregate Safety Assessment (ASA) initiatives, maintain ASA SharePoint (SPS), take meeting minutes, etc. 
  •   Coordinate periodic reports, work with external global vendor in the development of periodic reports. 
  •   Work with product responsible persons/ physicians and other stakeholders to ensure that periodic reports comply with the timelines and regulations. 
  •   Assist project teams in updating global and local controlled documents 
  •   Manage high volume of work generated from multiple regions. 
  •   Manage the controlled document approval process (review, approval, signatories) 
  •   Develop training content based on updates made to controlled documents. 
  •   Perform writing and project management activities for documents (e.g., PBRER, DSUR) including formatting text, tables, and appendices, apply styles, hyperlinking, versioning, Table of Contents, etc. 
  •   Assist with alternative wording, presentation, or style to ensure clarity of content. 
  •   Assist with issue resolution related to the document content. 
  •   Coordinate editing activities. 
  •   Compile source/supporting documentation for the quality control review process. 
  •   When necessary, manage the project timelines and deliverables of aggregate report projects (e.g., PADERs) working closely with the Safety Team. 
  •   Conduct quality control (QC) review, including verification of data against approved supporting documentation/sources of medical/scientific information for aggregate reports (e.g., PBRERs, DSURs, etc.). 
  •   Recommend changes for the QC findings 
  •   Record QC metrics per defined categories 
  •   Ensure accuracy and consistency of document 


Requirements 
  •   Hands on, relevant experience with controlled documents 
  •   Knowledge of PV SOPs and/or processes required 
  •   Ability to work effectively with remote team members 
  •   Must be able to work independently with minimal supervision. 
  •   Excellent organization skills. 
  •   Proficiency in MS Office Products required. 
  •   Excellent written and oral communication skills. 
  •   Strong leadership skills 
  •   Expert in Word, PowerPoint, Excel, and Adobe 
  •   Excellent listening and comprehension skills 
  •   Ability to work effectively in a matrix setting to resolve issues and achieve common goals 
  •   Thorough knowledge of GVP modules and ICH PV regulations 
  •   Proven project management skills and attributes evidenced by detailed project management experience. 
  •   Highly organized 
  •   Experience writing periodic reports, QC experience, process oversight experience, and process creation experience 
  •   Minimum 5 years of relevant experience in PV 
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