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Global drug and device development services

Operations Planner 2 - Clinical Supplies

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeWest Point, PA, USA

About the Job

Requirements

  • A bachelor's degree is preferred; candidates with relevant experience may be considered.
  • At least 4 years of experience in a related field; candidates without a degree should have at least 7 years of relevant experience.
  • Direct work experience with SAP is a plus.
  • Above-average proficiency in Microsoft applications, including Word, Excel, and PowerPoint.
  • Strong forecasting and collaboration skills.
  • Detail-oriented with strong organizational abilities.
  • Problem-solving and project management skills.
  • Ability to navigate cross-functionally.
  • Strong business acumen and ability to independently coordinate clinical materials activities in accordance with safety, regulatory, and company requirements.
  • Strong organizational, time-management, and analytical problem-solving skills, with ability to prioritize to mitigate supply-chain risks.
  • Ability to use SAP to translate clinical-trial packaging and labeling designs into electronic pharmaceutical production records and prepare executable master data.
  • Working knowledge of systems and processes required for Operations Planning deliverables, including SAP, CSST Appian, Microsoft Office including Excel, and SWMS.
  • Employment requires the legal right to work in the country where the role is based.

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 the 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 to create, review, and approve labeling and packaging documentation.
  • Provide input to, contribute to, and define process improvements.
  • Participate in and lead meetings with GCS and internal and external GCS stakeholders.
  • Build teamwork to improve process and productivity by working within and across client functional areas.

Desired Qualifications

  • Direct work experience with SAP.

About the Company

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Global drug and device development services

This company provides consulting, development, and commercialization support for drugs and medical devices through a global network of offices. Its team across 53 countries offers end-to-end services, from strategy and regulatory work to manufacturing and market access, helping clients shorten development time, lower costs, and raise quality. It differentiates itself with wide geographic reach and a clear focus on reducing time to market and cost while leveraging deep experience across many therapeutic areas. Its goal is to help clients accelerate the development of life-saving products and improve quality of life by delivering reliable information, practical solutions, and solid performance.

Company size
10,001+
Company stage
IPO
Headquarters
Ireland
Founded
1990

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