Associate Director, Planning & Scheduling - Hybrid

Job Description

The Global Clinical Supply (GCS) organization manages the “end-to-end” clinical supply for the company’s portfolio.  GCS is accountable for the planning, sourcing, labeling, packaging and delivery of clinical supplies to clinical sites across more than 60+ countries, in compliance with worldwide regulations, company policies and standard operating procedures.

The Translation Coordinator and Label Document Controller (TC/LDC) Lead is responsible for leading and overseeing the coordination of label translation activities and label document control operations to ensure accuracy, compliance, and alignment with GxP and company quality standards.  The TC/LDC lead manages day-to-day workflows, supports cross-functional stakeholders, maintains document integrity and ensures processes are executed in accordance with applicable regulatory and internal requirements.

Primary activities include, but are not limited to:

• Lead and oversee label translation coordination activities including intake, tracking, prioritization and completion of translation requests.

• Lead and oversee label documentation control activities including label generation, review/approval of vendor label proofs, randomization and variable text reports.

• Provide leadership, direction and coaching to team members responsible for translation and document control activities.

• Coordinate with cross-functional stakeholders to support business priorities, timelines and operational needs.

• Monitor workload, performance and resources to ensure operational and compliance expectations are achieved.

• Identify process gaps, delays or risks and implement or recommend corrective actions.

• Support audit readiness by ensuring documentation is current, organized and inspection ready.

• Contribute to process improvement initiatives to enhance efficiency, consistency and quality.

Experience and Skills:

• BS or equivalent in scientific, business or related discipline.

• Knowledge of GxP and quality systems

• Excellent written and verbal communication skills

• Strong stakeholder management and collaborations skills.

• Ability to work in a fast-paced environment, manage competing priorities and adapt to changing business needs. 

• Ability to lead, coach and develop team members.

Required Skills:

Clinical Supply Chain Management, Coaching, Corrective Action Management, Document Controls, Driving Continuous Improvement, Inventory Control Management, Logistics Management, Master Batch Records, Oral Communications, Pharmaceutical Packaging, Prioritization, Process Improvements, Professional Integrity, Project Leadership, Project Management, Quality Oversight, Results-Oriented, Stakeholder Management, Supply Chain Metrics

Preferred Skills:

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