Regulatory Publishing Technical Consultant (Regulatory Systems)

Parexel; United States; Hybride; USD 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Comprehensive benefits

Direct client engagement

Mentoring and professional development

Résumé du poste

Parexel is seeking a Technical Consultant to join our Regulatory Operations team. You will serve as a subject matter expert for regulatory publishing systems, document management technologies, and electronic submission tools used to support global regulatory activities.

You will partner with internal teams, software vendors, and external clients to provide technical support, troubleshoot complex issues, and ensure effective use of publishing and regulatory information management solutions.

Qualifications

• 3+ years of experience in Regulatory Operations, Regulatory Publishing, eCTD Submission Management, Regulatory Technology Support, or Regulatory Information Management.
• Experience with one or more platforms such as Veeva Vault RIM, Documentum, EXTEDO, Lorenz, Calyx RIM or similar systems.
• Strong understanding of eCTD submissions, regulatory publishing processes, and global submission standards.

Responsabilités

• Provide technical support for regulatory publishing and submission management systems.
• Troubleshoot issues related to eCTD publishing tools, document management systems, PDF creation, Microsoft Office applications, and desktop environments.
• Configure, install, test, validate, and maintain regulatory technology solutions.
• Support system validation activities, execute test scripts, and document results.
• Maintain compliance with regulatory submission standards, publishing guidelines, and industry best practices.
• Manage multiple priorities while ensuring high-quality deliverables and service levels.
• Partner with clients, regulatory teams, and software vendors to resolve technical challenges and deliver effective solutions.
• Act as a trusted advisor on publishing technologies and regulatory systems.
• Support project teams by sharing expertise and mentoring less experienced team members.
• Participate in client meetings and provide recommendations to improve efficiency and system utilization.
• Build strong relationships with internal and external stakeholders while ensuring client satisfaction.

Connaissances

Regulatory Operations

Regulatory Publishing

eCTD Submission Management

Regulatory Technology Support

Regulatory Information Management

Microsoft Office

Adobe Acrobat

Windows OS

Fluent English

Formation

Bachelor’s degree in Life Sciences or related field

Outils

Veeva Vault RIM

Documentum

EXTEDO

Lorenz

Calyx RIM

Description du poste

When our values align, there’s no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world’s health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we’re committed to making a difference.

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

About the Role

Parexel is seeking a Technical Consultant to join our Regulatory Operations team. In this role, you will serve as a subject matter expert for regulatory publishing systems, document management technologies, and electronic submission tools used to support global regulatory activities.

You will partner with internal teams, software vendors, and external clients to provide technical support, troubleshoot complex issues, execute validation activities, and ensure the effective use of publishing and regulatory information management solutions.

This position is ideal for professionals with experience in Regulatory Operations, eCTD Publishing, Regulatory Technology, or Regulatory Systems Support who enjoy combining technical problem-solving with client-facing consulting responsibilities.

What You Will Do

Regulatory Systems & Publishing Support

• Provide technical support for regulatory publishing and submission management systems.
• Troubleshoot issues related to eCTD publishing tools, document management systems, PDF creation, Microsoft Office applications, and desktop environments.
• Configure, install, test, validate, and maintain regulatory technology solutions.
• Support system validation activities, execute test scripts, and document results.
• Maintain compliance with regulatory submission standards, publishing guidelines, and industry best practices.
• Manage multiple priorities while ensuring high-quality deliverables and service levels.

Consulting & Client Engagement

• Partner with clients, regulatory teams, and software vendors to resolve technical challenges and deliver effective solutions.
• Act as a trusted advisor on publishing technologies and regulatory systems.
• Support project teams by sharing expertise and mentoring less experienced team members.
• Participate in client meetings and provide recommendations to improve efficiency and system utilization.
• Build strong relationships with internal and external stakeholders while ensuring client satisfaction.

Required Experience & Qualifications

Must-Have Experience

• 3+ years of experience in:
  • Regulatory Operations
  • Regulatory Publishing
  • eCTD Submission Management
  • Regulatory Technology Support
  • Regulatory Information Management (RIM)
• Experience supporting or using one or more of the following platforms:
  • Veeva Vault RIM
  • Documentum
  • EXTEDO
  • Lorenz
  • Calyx RIM
  • Similar regulatory publishing or document management systems
• Strong understanding of:
  • eCTD submissions
  • Regulatory publishing processes
  • Global regulatory submission standards
  • Submission lifecycle management
• Experience performing:
  • System troubleshooting
  • Software testing
  • Validation activities
  • User support
• Advanced proficiency with:
  • Microsoft Office Suite
  • Adobe Acrobat
  • Windows operating systems
• Fluent English communication skills, both written and verbal.
• Bachelor’s degree in Life Sciences, Technology, Computer Science, Pharmacy, Regulatory Affairs, or a related field.

Preferred Qualifications

• Experience writing and executing validation protocols and test scripts.
• Experience working within a CRO, pharmaceutical, biotechnology, or regulatory technology environment.
• Prior client-facing or consulting experience.
• Experience mentoring team members or acting as a subject matter expert.

Success in This Role

You will be successful if you have hands-on experience with regulatory publishing technologies and enjoy solving technical challenges while working closely with clients and cross-functional teams. Candidates with backgrounds in eCTD Publishing, Regulatory Operations, Regulatory Systems, Veeva Vault RIM, Documentum, EXTEDO, or Regulatory Technology Support are strongly encouraged to apply.

What We Offer

• Opportunity to work with cutting-edge regulatory technology and publishing systems
• Exposure to global regulatory standards and best practices
• Collaborative, matrix-based environment with opportunities for mentoring and professional development
• Direct client engagement and the ability to drive meaningful business solutions
• Competitive compensation and comprehensive benefits package

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

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