Operations Planner II, Clinical Supplies

IRE•West Point, PA
•Hybrid

About The Position

At ICON Strategic Solutions, the Operations Planner II works in a sponsor-dedicated model supported by ICON’s global expertise. The role involves advanced planning activities, mentoring junior-level peers, strong business acumen, and cross-functional collaboration. The planner independently coordinates activities for timely packaging, labeling, and assembly of clinical materials for designated domestic and international studies, in accordance with applicable safety and regulatory requirements and company policies. Responsibilities include processing study-specific packaging and labeling documentation, coordinating packaging jobs through work centers, and reviewing documentation and procedures. This is a hybrid role requiring three days onsite weekly in West Point, Pennsylvania (19486).

Requirements

  • At least 4 years of experience in a related field; candidates without a degree should have at least 7 years of relevant experience.
  • Strong forecasting and collaboration skills.
  • Detail-oriented, with strong organizational abilities.
  • Problem-solving and project management skills.
  • Ability to navigate cross-functionally.
  • Above-average proficiency in Microsoft Word, Excel, and PowerPoint.
  • Strong working knowledge of processes and systems required for Operations Planning deliverables, including SAP, CSST Appian, Microsoft Office (including Excel), and SWMS.
  • Legal right to work in the country where the role is based.

Nice To Haves

  • Bachelor’s degree preferred; candidates with relevant experience may be considered.
  • Direct work experience with SAP.

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 third-party vendors to support clinical packaging jobs.
  • Monitor adherence to project schedules and document progress in relevant databases.
  • Mentor junior-level peers and provide guidance on planning processes.
  • Analyze and anticipate technical problems and obstacles related to clinical supplies packaging, and participate in adjusting drug-supply logistics.
  • 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 on the creation, review, and approval of labeling and packaging documentation.
  • Provide input to, contribute to, and define process improvements.
  • Participate in and lead meetings with GCS and GCS stakeholders, internally and externally to Operations Planning.
  • Use SAP to translate clinical trial packaging and labeling designs into electronic pharmaceutical production records and prepare executable master data.
  • Build teamwork to improve processes and productivity across client functional areas.

Benefits

  • Competitive base salary and performance-related incentives.
  • Medical, dental, and vision coverage where applicable.
  • Retirement and pension plans.
  • Life assurance and disability coverage.
  • Employee assistance programmes and wellbeing resources.
  • Learning and development opportunities through structured training and career pathways.
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