The Role
Do you want to be part of something new and up and coming? Do you like digging in deep and solving problems? Do you have a solid understanding of eCTDs and the nuances of successfully getting a submission to the Health Authorities? Come help us shape a new paradigm for submissions publishing. Veeva’s Vault RIM suite is the industry’s only unified software solution that provides fully integrated regulatory information management (RIM) capabilities including data and document management, submission publishing, and archival on a single cloud-based platform.
Veeva Systems is looking for experts in Regulatory Operations, specifically, eCTD publishing, who are dedicated and passionate about helping our customers implement a new publishing technology.
As a key member of the Professional Services team, the Publishing Consultant will be responsible for understanding our customers' global regulatory eCTD publishing needs and adopting Vault Submissions Publishing.
Opportunities are available across Europe for this role; this is a remote position. There is no work location requirement as long as you are close to an airport and able to meet travel requirements. Qualified EU-based candidates are encouraged to apply.
What You'll Do
- Utilize best practices to support Vault Submissions Publishing deployment projects,
- Ensure continued customer success post-implementation,
- Gain an in-depth understanding of Publishing use cases (eCTD, non-eCTD, Paper, Device) and how the Vault Submissions Publishing application aligns with those use cases,
- Work collaboratively with the product team to pass on customer feedback regarding use cases and requests for product improvement.
Requirements
- Minimum of 4 years of pharmaceutical industry, regulatory publishing/submissions management experience,
- Technologically savvy with the ability to quickly learn software applications and troubleshoot as needed,
- Fluent understanding of regulatory submission processes and requirements including eCTD publishing principles and lifecycle management,
- Working knowledge of health authority regulations and industry standards of regulatory operations,
- Experience working with EU and US Regulatory Agencies supporting Regulatory Dossier review and approval processes,
- Excellent skills in oral and written communications, integrity, and adaptability,
- Ability to work independently in a fast-paced environment,
- Ability to travel up to 40%