Senior Clinical Packaging Operations Coordinator

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

📋 Description

• Oversee the technical content and execution of packaging initiatives via Third Party Contractors.

• Direct external packaging work packages for designated clinical studies, ensuring adherence to established timelines, quality standards, and GMP compliance.

• Define and scope technical requirements for outsourced projects; evaluate feasibility, risks, timelines, and resource needs in collaboration with internal stakeholders.

• Manage technical documentation and readiness for execution: approve batch records and label texts, facilitate material flows to TPCs, and conduct technical reviews of finalized documentation.

• Serve as the primary liaison with TPCs to align on technical expectations, oversee execution, address issues, and escalate risks as necessary.

• Lead planning, prioritization, and progress monitoring using agreed-upon tools; provide transparent status updates to the CSC and key stakeholders.

• Ensure documentation accuracy, completeness, and compliance, maintaining data integrity.

• Track and report relevant performance and delivery metrics for assigned studies.

⛳️ Requirements

• Proven understanding of the R&D environment, the drug development lifecycle, GMP, and the packaging of Clinical Trial Supplies.

• Exceptional accuracy and attention to detail.

• Capable of working independently on daily tasks; skilled in identifying issues and either resolving or escalating them.

• Able to plan effectively and adjust priorities in response to changing demands to meet deadlines.

• Possesses a continuous improvement mindset, with the ability to propose tangible enhancements.

• Represents the company professionally when interacting with external TPCs.

• Demonstrates effective verbal, written, and presentation abilities.

• Exhibits effective collaboration within matrix teams and works across boundaries.

• Understands the pharmaceutical and clinical development processes and their connection to clinical supplies delivery; knowledgeable about clinical supply GMP requirements and standards.

• Experience in project coordination.

• Comprehensive understanding of the end-to-end clinical supplies delivery chain: API & DP manufacturing, packaging, and distribution activities.

• Keeps current with clinical supply requirements and standards, GMP, and relevant global regulations.

🏝️ Benefits

• Various annual leave entitlements.

• A range of health insurance options tailored to meet the needs of you and your family.

• Competitive retirement planning options to maximize savings and help you plan confidently for the future.

• Global Employee Assistance Programme, TELUS Health, providing 24-hour access to a worldwide network of over 80,000 independent specialized professionals dedicated to supporting your and your family’s well-being.

• Life assurance.

• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, and more.