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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Clinical Publisher Associate


Reference:SCAAPI-442514 Location: Cork
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Regulatory Affairs Clinical Research

Clinical Publisher Associate
Our client, a global pharma company are currently recruiting for a Clinical Publisher Associate to join their team on a permanent basis. As Clinical Publisher you will create and maintain complex strategic and compliance submissions through collaboration, document management, and internal database maintenance. You will collaborate with Regulatory Associates, Regulatory Scientists, cross-functional contributing/authoring areas, and affiliates to align on submission specific strategies and to ensure adherence to eCTD regulations and guidelines. You will provide business process knowledge and leadership to customers to resolve publishing issues and drive on time submissions.


Responsibilities:

  • Serve as electronic secondary publishing process expert to create, update, maintain, and archive complex dossiers using appropriate lifecycle management
  • Demonstrate in-depth understanding of ICH CTD format/s requirements and evolving US/OUS agency standards/trends
  • Provide publishing to influence strategies of upstream contributors/vendors to enable successful implementation with minimal impact to resources and supply chain
  • Act as primary publishing lead on large marketing applications and coordinate the combined efforts of additional publishers, Regulatory Associates, Nonclinical publishers, CMC publishers, and Labelling to deliver the submission
  • Understand, log, and manage Incoming Correspondence from and all Records of Contact with the FDA to enable rapid and accurate updates impacting project timelines and pending approvals
  • Accountable as process owner of a specific process to technically evaluate, drive improvements and contribute to RQS procedures
  • Apply high level of technical expertise and proficiency in electronic publishing tools and systems (e.g., eCTDXpress, ISI Toolbox, Adobe Acrobat, Leo, Global Content Gateway to ensure compliance
  • Demonstrate in-depth understanding of complex multiple FDA forms and apply project knowledge to ensure accurate submissions
  • Coordinate across geographies to create different dossiers for Europe, Swiss, Canada or other supported worldwide markets. Collaborate with affiliate publishers to align and deliver on local specifications for the submission
  • Coordinate with Regulatory Scientists to process, publish, and submit U.S. FDA required post-marketing supplements and amendments. Recognize erroneous metadata and/or documents and influence to correct
  • Make decisions based on ICH guidance and global regulations to ensure compliant submissions and to drive improvements
  • Identify errors in documents from contributing authors/vendors and initiates resolution of issues/errors/discrepancies
  • Participate in and understand the goals of the regulatory publishing strategies of assigned molecules
  • Use molecule/product and registration knowledge to accurately assign keywords, and accurately populate/execute complex FDA Forms
  • Facilitate efficient review of the registration by the regulatory agency
  • Ensure compliance submissions are delivered on time
  • Positively impact regulatory cross-functional initiatives through active participation in process improvement projects
  • Conduct submission planning for assigned portfolio by identifying publishing milestone requirements for upcoming submissions and planning/managing workload to ensure on time submissions
Requirements:
  • BSc Degree qualified in a related field
  • Three years’ experience publishing submissions using eCTDXpress
  • Demonstrated project management and time management skills
  • Demonstrated organization and priority setting skills: must be able to manage diverse tasks and processes
  • Flexibility, ability to handle time pressures
  • Demonstrated ability to communicate and negotiate solutions to complex technical challenges with cross-functional colleagues and customers
  • Cognitive abilities, including verbal reasoning, attention to detail, critical thinking, and analytical ability
  • High-end computer and word processing/editorial skills: templates, spreadsheets, graphics, databases.
  • Proficiency in SharePoint technology
  • Proven ability to take initiative and identify issues and solutions
  • General knowledge of scientific literature and library retrieval
  • Ability to work well independently and as part of a team, and ability to assertively marshal the efforts of multiple contributors to projects
  • Self-motivated
  • Effective communication/interpersonal skills
  • Must be able to maintain the security of confidential information