Senior Global Clinical Process Management Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide coordination and operational assistance to Process Leads and senior GCPM leadership.

• Assist in the review and approval workflows of documents.

• Oversee document control activities, including QA alignment, DCC activities, and tracking of approvals.

• Collect, prepare, tabulate, and organize inputs for the review and decision-making process of the Process Lead.

• Create, document, and sustain project plans, including status reviews and follow-ups.

• Maintain lists of stakeholders, materials for meeting planning, and drafts of project charters.

• Aid in organizational change management activities and draft communications.

• Compile data from Veeva Vault or similar systems for status reporting and process evaluations.

• Prepare and manage QE CAPA tables and related tracking materials.

• Analyze GCPM intake-form data for management reviews, process enhancements, and innovation assessments.

⛳️ Requirements

• A bachelor’s degree is required.

• A minimum of 2 years of experience in the pharmaceutical and/or biotechnology industry is preferred.

• Proficient in the Microsoft Office Suite (Excel, Outlook, Word, PowerPoint, Project).

• Fluent in English, both oral and written.

• Familiarity with ICH-GCP guidelines.

• Strong interpersonal and problem-solving capabilities.

• Excellent organizational skills with a focus on quality management and process improvement.

• Effective communication skills, both verbal and written.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial positions.

• Inclusion in an incentive compensation plan for commercial roles.

• Discretionary equity awards.

• Option to voluntarily participate in the Employee Stock Purchase Plan.

• Medical insurance coverage.

• Dental insurance coverage.

• Vision insurance coverage.

• 401(k) plan.

• Flexible Spending Account / Health Savings Account (FSA/HSA).

• Life insurance coverage.

• Paid Time Off (PTO).

• Wellness programs.