Our client, a growing Pharmaceutical and Biotech Company is looking for an Associate Director of Regulatory Publishing to join a world renowned team with a growing pipeline.
DESCRIPTION OF JOB DUTIES
- Maintain all regulatory reports, documents and publications are submitted according to ICH, eCTD, and other electronic publishing standards.
- Ensure quality of published documentation internally and from sponsors.
- Act as a manager within internal and external software personnel and vendors to ensure proper electronic submission, document control, and validation on other software/systems
- Maintain libraries of reference including regulatory guidance updates.
- Act as a Training and Development liaison to conduct procedural and software L&D Sessions.
- Support Quality Assurance
QUALIFICATIONS/REQUIREMENTS
- At least 6 years of clinical research electronic publishing experience, including international experience.
- Prior experience using publishing tools including Adobe Acrobat Professional, ISI Toolbox, and Extedo eCTD Manager.
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