Operations Planner II, Clinical Supplies

Operations Planner II, Clinical Supplies

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

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 are 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.

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

What ICON can offer you:

• Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
• In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you 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, among others.