Regulatory Publishing Specialist

Position Overview

• Location Type:
• Job Type: Full time
• Work Schedule: Standard (Mon-Fri)
• Environment: Office

This role provides experienced strategic, expedient, and efficient preparation of client electronic submission deliverables and dossiers that meet current local, regional, and ICH regulatory and technical requirements. The position ensures successful regulatory review outcomes for product milestones and serves in a quality review capacity, being responsible for the thorough review of documents to ensure they meet or exceed client expectations.

Essential Functions and Responsibilities

• Provides expertise in client submission deliverables supporting regulatory compliance.
• Prepares components of electronic regulatory submissions that meet electronic document requirements set by regulatory guidance, publishing documents, and submissions compatible with sponsor and/or regulatory agency software programs.
• Addresses consistency and security issues within submissions.
• Maintains the document lifecycle for submission documents.
• Leads the development and implementation of project-specific processes for sponsors with unique technology requirements.
• May act as the company's liaison for regulatory submissions with the sponsor and assist project teams in executing regulatory submission strategies.
• Provides leadership by participating in training, skill development, and mentoring of other electronic submission personnel.
• Uses professional judgment to evaluate publishing needs in relation to overall project timelines, quality, and delivery.
• Engages other project team members, functional units, or publishing management as necessary to deliver the final product and resolve/mitigate identified issues or barriers.
• Acts independently within a project team or as the project team lead to evaluate and deliver publishing tasks.

Job Complexity and Knowledge

• Works on problems of diverse scope where analysis of data requires the evaluation of identifiable factors.
• A seasoned, experienced professional with a full understanding of the area of specialization, resolving a wide range of issues in creative ways. This is a fully qualified, career-oriented, journey-level position.

Supervision and Relationships

• Supervision Received: Normally receives little instruction on day-to-day work, with general instructions on new assignments. Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
• Business Relationships: Represents the department as a prime contact on projects. Interacts with internal and external personnel on significant matters, often requiring coordination between functional areas. Networks with senior internal and external personnel in the area of expertise.

Qualifications

• Education and Experience:
  • Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
  • Previous experience equivalent to 5+ years that provides the necessary knowledge, skills, and abilities.
  • In some cases, an equivalency consisting of a combination of appropriate education, training, and/or directly related experience will be considered sufficient.
• Knowledge, Skills, and Abilities:
  • Strong knowledge of regulatory requirements and guidances for document management and electronic submissions.
  • Advanced knowledge of Microsoft (MS) Word, MS Excel, Adobe Acrobat, electronic document management systems, document publishing tools, publishing systems, eCTD validation, and viewing tools.
  • Advanced knowledge of electronic templates and skill in formatting and troubleshooting templates.
  • Ability to manage several complex projects in parallel and adapt to changing priorities.
  • Ability to exercise independent judgment in developing methods, techniques, and evaluating criteria using defined procedures and practices.
  • Ability to independently assess publishing needs.