Process & Procedure Portfolio Specialist

Role Summary

Join our team in Warren as a Process & Procedure (P&P) Specialist. You will support Global Development Process & Procedure's portfolio management activities and contribute to the controlled document development lifecycle in a global environment. With minimal guidance, you will apply your expertise to improve operational efficiency and impact the team's success.

Responsibilities

• Developing and maintaining tools to monitor and track procedural document portfolios.
• Support the identification and compilation of metrics.
• Leading portfolio reviews with P&P Leads, including KPI assessments and risk escalations.
• Creating and executing standard reports, dashboards, and metrics to meet organizational needs.
• Analyzing portfolio data to identify trends, risks, and improvement opportunities.
• Supporting compliance activities related to audits, inspections, and process deviations.
• Monitoring project plans for compliance and tracking their status.
• Streamlining team files, communication templates, and repositories for operational efficiency.
• Coordinating logistics for internal and external meetings, ensuring follow-up on actions.
• Organizing and maintaining onboarding materials for new team members.

Qualifications

• Required: Bachelor's Degree with at least 2 years of relevant experience.
• Required: Strong expertise in Microsoft Office (Excel, PowerPoint), data analysis, and visualization tools.
• Preferred: Experience in biopharma or using EDMS.

Skills

• Analytical mindset with the ability to identify data trends, develop metrics, and use visualization tools to support decision-making.
• Proficiency in project management principles and the ability to manage competing priorities.
• Ability to collaborate across teams and communicate effectively at all organizational levels.
• Detail-oriented with a focus on accuracy and adherence to standards.
• Self-motivated and capable of working independently with minimal supervision.
• Experience with AI tools and Electronic Data Management Systems (EDMS).
• Interest in contributing to a regulated, global environment, preferably in biopharma.

Education

• Bachelor's Degree required.