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Sr. Specialist, Regulatory Operations

  • Type Contract
  • Salary competitive
  • Location Maryland, USA
  • Sectors Pharma & Biotech

Title: Senior Specialist, Regulatory Operations

Openings: 2

Duration: 6 Months (extendable)

Location: Maryland

Onsite vs. Remote: Can work remote; onsite as needed (local candidates preferred)

Summary of Position

This is a senior-level Regulatory Operations position responsible with the preparation, compilation and QC of regulatory submissions to Regulatory Health Authorities (e.g., FDA). The incumbent in this role will be primarily focused on Word formatting, PDF publishing and eCTD backbone compilation of regulatory submissions. In addition, this role will be responsible for archiving regulatory submissions, training company employees on Regulatory Operations tools, such as an Electronic Document Management System (EDMS) and mentoring junior staff.

Responsibilities and Job Duties

  • Under direct supervision, performing Word/PDF publishing and formatting of regulatory submission documents to ensure that they meet company's style and publishing guidelines
  • Perform routine submission publishing and eCTD backbone compilation activities associated with electronic and hard copy submissions
  • Formatting Word documents by applying appropriate styles/templates
  • Formatting PDF documents using Acrobat and Acrobat PDF Plug-ins (i.e., ISI Toolbox or equivalent)
  • Perform QC checks of submissions documents and compiled submission output to ensure that they comply with Regulatory Operations and electronic submissions best practices
  • Interface with Project Managers, Regulatory Leads, and/or content authors to provide technical guidance and support in finalizing submission content
  • Train cross-functional submission authors on Regulatory Operations content standards and software/eCTD initiatives
  • Responsible for quality and format of documents for submission using an electronic document management system
  • Coordinating aspects of publishing activities that includes bookmarking, hyperlinking, and creating CDs/DVDs of submission package
  • Managing and maintaining submission logs
  • Administering routine file management and provide user support on EDMS system
  • Provide validation and implementation support of Regulatory Operations systems
  • Mentor junior Regulatory Operations staff on PDF publishing and formattingEducation & Other Credentials

Minimum Qualifications

BA/BS or equivalent; Science/technical-related major preferred

Experience

3-5+ years of Regulatory Operations experience using appropriate software tools in a biotechnology, pharmaceutical and/or CRO environment

Knowledge, Skills and Abilities

    • Advanced proficiency with MS Office applications, Adobe Acrobat, and Acrobat plug-ins such as ISI Toolbox is required
    • Advanced proficiency e with eCTD building/compilation software (EXTEDO eCTDmanager preferred)
    • Experience with Electronic Document Management Systems [e.g., Veeva Vault, ContentServer (formerly LiveLink), FDRD/Documentum, SharePoint etc.] is required
    • Understanding of and experience with US and global electronic submission requirements is required
    • Ability to work in a scientific and technical-oriented environment
    • Ability and desire to work well with diverse employees and customers in a cooperative and friendly manner
    • Must possess ability to handle multiple priorities in a fast-paced environment
    • Must possess excellent written and verbal communications skills
    • Must also be able to facilitate occasional projects not possible during normal business hours due to vendor necessity or customer impact (e.g. ability to be on call for any critical submission-related issues)

Must be a U.S. Citizen or Lawful Permanent Resident

Preferred Qualifications

  • Expert working knowledge of MS Word, including the ability to create Word styles, templates
  • Knowledge or experience with Adobe Acrobat, Acrobat plug-ins, EDMS, and eCTD compilation software is preferred
  • Knowledge or experience in eLearning software and website/infographic design tools for creating training materials and user guides
  • Knowledge of HTML/XML helpful
  • Experience with validation/implementation of Regulatory Operations systems (compilation tools/templates/EDMS)

Sthree US is acting as an Employment Business in relation to this vacancy.