Operations Planner II, Clinical Supplies
ICON plc
Summary
The Operations Planner II is responsible for advanced planning activities and mentoring of junior level peers. This role requires strong business acumen and the ability to navigate cross-functionally. This role is responsible for independently coordinating all activities associated with timely packaging, labeling and assembly of clinical materials for designated domestic and international studies in accordance with applicable safety and regulatory requirements as well as company policies. This individual is responsible for execution of clinical supplies activities including but not limited to the processing of study specific packaging and labeling documentation, coordination of packaging jobs as they progress through work-centers, and review of documentation and procedures.
Job description
Key Responsibilities
- Execute and lead planning activities for program level tasks and follow up on their completion.
- Operationalize documents detailing protocol level packaging and labeling strategy for internally and externally packaged clinical supplies
- Execute and oversee planning of clinical packaging events at internal and external packaging facilities.
- Manage Re-Packaging and R.E.D. Extension packaging jobs, including drug salvage operations
- Track deliverables at 3rd party vendors to support clinical packaging jobs
- Monitors the adherence to project schedules and documents progress in respective databases.
- Mentor junior level peers and provide guidance on planning processes.
- Analyzes and anticipates technical problems and obstacles as they relate to clinical supplies packaging and participates in adjustment of logistics pertaining to drug supply.
- Collaborate with cross-functional teams to support business objectives
- Triage events and issues as required to ensure study timelines are met
- Collaborate with Project Managers, Planners, Packaging Supervisors and Quality Assurance for the creation, review and approvals of labeling and packaging documentation.
- Provide input, contribute to, and define process improvements
- Participate and lead meetings with GCS and GCS stakeholders internally and externally to Operations Planning
- Possess strong organizational, time management and analytical problem-solving skills, with ability to prioritize to mitigate supply chain risks
- Ability to use SAP system to translate clinical trial packaging and labeling designs into electronic pharmaceutical production records and preparation of executable master data
- Demonstrate strong working knowledge of process/systems required to ensure successful execution of Operations Planning deliverables, including but not limited to, SAP, CSST Appian, Microsoft Office, including Excel, SWMS
- Build teamwork to improve process and productivity by working within and across client functional areas
Qualifications
- Bachelor's degree preferred; candidates with relevant experience may be considered.
- 4+ years of experience in a related field; candidates without a degree should have 7+ years of relevant experience.
- Direct work experience with SAP is a plus
- Above average proficiency in Microsoft applications (Word, Excel, PowerPoint).
General Skills
- Strong forecasting and collaboration skills.
- Detail-oriented with strong organizational abilities.
- Problem-solving and project management skills.
- Ability to navigate cross-functionally
Requirements
- Bachelor's degree preferred; candidates with relevant experience may be considered.
- 4+ years of experience in a related field; candidates without a degree should have 7+ years of relevant experience.
- Direct work experience with SAP is a plus
- Above average proficiency in Microsoft applications (Word, Excel, PowerPoint).
- Strong forecasting and collaboration skills.
- Detail-oriented with strong organizational abilities.
- Problem-solving and project management skills.
- Ability to navigate cross-functionally
Benefits
- Medical, Dental & Vision
- Retirement Plans
- Pension Plans
- Life Assurance
- Disability Coverage
- Employee Assistance Programs
- Wellbeing Resources
- Structured Training
- Career Pathways
Company overview
ICON plc is a global leader in clinical research and healthcare intelligence, founded in Dublin, Ireland in 1990. As one of the world's largest contract research organizations (CROs), ICON provides comprehensive outsourced development services to pharmaceutical, biotechnology, and medical device companies worldwide. The company operates in 55 countries with approximately 41,900 employees, offering end-to-end solutions that span the entire product development lifecycle. ICON's service portfolio includes clinical research services, adaptive trials, biosimilars, commercialization and outcomes consulting, medical imaging, laboratory services, and strategic support for traditional and digital health technologies. The company specializes in therapeutic areas such as oncology, cardiovascular diseases, central nervous system disorders, rare diseases, and women's health. With its 2021 acquisition of PRA Health Sciences, ICON significantly expanded its capabilities and market position, becoming a dominant force in the global CRO industry. The company is publicly traded on NASDAQ under the ticker ICLR and reported $8.28 billion in revenue for 2024.