Note: The job is a remote job and is open to candidates in USA. Atrium is recruiting a Regulatory Project Manager for a temporary contract assignment supporting Vertex Pharmaceuticals. The role leads and coordinates global regulatory affairs advertising and promotion projects and portfolios, builds project management capabilities, and supports compliant regulatory submissions through cross-functional collaboration.
Responsibilities
- Build and institutionalize regulatory project management frameworks, tools, and best practices to enhance GRA-AP capability and effectiveness
- Provide strategic oversight of GRA-AP projects and portfolios, ensuring alignment with objectives and timelines
- Coordinate and facilitate communication among regulatory affairs, project teams, stakeholders, and external partners to support project execution
- Track project progress, materials, and deliverables, proactively identifying and resolving issues to maintain project momentum
- Lead and participate in regulatory project meetings, including documenting minutes, updating project portals, and communicating outcomes to stakeholders
- Perform administrative functions to support project teams and department operations
- Assume additional duties as assigned to ensure regulatory project and portfolio success
Skills
- • Bachelor's degree in a scientific discipline, regulatory affairs, project management, or a related field
- • Minimum of 3 years' experience in regulatory project management within the pharmaceutical or biotechnology industry, or an equivalent combination of education and experience
- • Experience managing and cross-functional project teams is essential
- • Demonstrated ability to build project management frameworks, explain procedures, and drive regulatory advertising and promotion compliance initiatives
- • Excellent communicator, both written and verbal, with proven stakeholder engagement, strong briefing, and influencing skills
- • Strong organizational, analytical, and problem-solving skills, with a focus on continuous improvement
- • Proficient in project and knowledge management software and techniques
- • Advanced computer skills to support and maintain department software (e.g., Microsoft platform, OneDrive, SharePoint), and regulatory platforms (e.g., Veeva)
- • Ability to work independently and under moderate supervision, managing competing priorities across several projects
- • Preferred familiarity with monitoring and ensuring compliance with regulatory standards, guidelines, and submission requirements
Benefits
- Medical benefits and fringe benefits will be presented by the third-party agency partner upon offer.
- This role will be eligible for overtime pay, in accordance with federal and state requirements.
Company Overview
Company H1B Sponsorship