For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
Responsibilities:
- Configure and maintain system components including users, roles, metadata, and document lifecycles (business configuration, not IT development)
- Develop and maintain SOPs, work instructions, and system documentation to support regulatory operations
- Conduct end-user training and drive adoption of Veeva Vault RIM across stakeholders
- Monitor and manage audit trails, issue logs, and validation-related activities to ensure compliance
- Develop dashboards and reports to support regulatory submissions, health authority (HA) communications, and compliance tracking
- Collaborate cross-functionally with Regulatory Affairs, IT, and Quality teams to support system improvements and operational needs
- Support inspection readiness and contribute to audits and regulatory interactions
Education and Skills Requirements:
- Bachelor’s or Master’s degree in Life Sciences, Information Systems, or a related field
- Minimum of 5–7+ years of hands-on experience with Veeva Vault RIM in a life sciences or pharmaceutical environment
- Strong background in Regulatory Operations, including global regulatory submissions and health authority interactions (e.g., FDA, EMA, and other global agencies)
- Demonstrated experience as a Veeva Vault RIM power user from a Regulatory Operations perspective (This is not an IT or technical development role)
- Experience operating within GxP-regulated environments, with a solid understanding of compliance and validation requirements
- Proven experience supporting and leading user acceptance testing (UAT) activities
- Experience developing SOPs, work instructions, and supporting system documentation
- Strong experience supporting audits, inspection readiness, and regulatory compliance activities
- Demonstrated ability to translate business needs into system solutions and drive system adoption
- Excellent communication and stakeholder management skills, with the ability to work cross-functionally across Regulatory, IT, and Quality teams
- Ability to work independently and operate in a highly autonomous manner with minimal oversight
- Experience developing and delivering end-user training and driving system adoption is required
- Veeva Vault Administrator Certification is preferred
- Candidates must demonstrate recent, hands-on experience supporting Veeva Vault RIM in regulated life sciences environments
Engagement Details:
- Contract Duration: 12-month contract with potential for extension based on performance and business needs
- Engagement Type: Full-time contractor (FTE-equivalent)
- Time Zone Required: EST hours
- Location / Delivery Model: Primarily remote, with potential for occasional on-site presence in Waltham, MA as needed
- Travel: May be required for end-user training and key project phases
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
