Project Manager, Clinical Supply Operations (3109) (Elizabeth)

Employment Type

: Full-Time

Industry

: Non-Executive Management



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Project Manager, Clinical Supply Operations (3109)

Project Manager, Clinical Supply Operations

CONTEXT & INITIATIVE DESCRIPTION
Our Pharmaceutical Client is seeking an experienced Project Manager in the area of Clinical Supply Operations to strategize, implement and fully execute several ongoing projects and critical initiatives spanning their current portfolio.

This Client is ramping up several projects, mostly within Oncology, with product launches starting as early as Q1 2020 and need Project Management expertise in order to prioritize and maintain strict deliverables and timelines. This position will report to the Director of Project Management.

DUTIES/EXPECTATIONS OF THIS ROLE
  • Responsible for on time delivery of clinical supplies for studies across the entire portfolio of products
  • Responsible for ensuring supplies for assigned projects are manufactured, packaged, labeled and distributed on time to support all Phases (1-4) of required studies
  • Assure availability of drug product, interpret clinical protocols, develop Supply Plan Agreements
  • Develop and Maintain study-level budgets
  • Work closely with Supply Planning and Logistics Team to ensure all tasks and supply plans are executed in a timely manner and within budget
  • Evaluate, select, and implement contract manufacturing, packaging, and labeling
  • Negotiate work orders/proposals, in collaboration with Supply Chain and Logistics and oversee operations
  • Act as primary liaison with clinical personnel on assigned projects
  • Participate in the design of overall clinical plans and study protocols. Recommend type and method of packaging, labeling, and distribution. Translate protocol requirements and study milestones into an actionable Supply Plan Agreement
  • Collaborate with clinical teams on forecasting and delivering supply assessments to the appropriate planning functions
  • Recommend matching placebo drug sources
  • Develop appropriate strategies for regulatory CMC filing (domestic and international)
  • Identify emerging trends, technologies, and best practices and implement as appropriate
  • Assist in the establishment of Standard Operating Procedures (SOPs) and guidelines related to production planning and scheduling, inventory management, distribution, transportation, disposition of returned/unused materials, etc.
  • Responsible for overseeing an annual budget of 10M+
MUST HAVES QUALIFICATION SUMMARY
  • 7+ years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development
  • B.S./B.A. degree
NICE-TO-HAVES
  • Oncology Experience
  • Experience with creation of Supply Planning Tools
TRAVEL & LOCATION
New Jersey. Onsite 3 days/week and ability to work offsite 2 days/week

START & TERM
Immediately, 6+ months

CONSULTING RATE
Competitive

Job Details


State

New Jersey=NJ

Associated topics: advertising promoting, brand manager, brand marketing, business development, market, marketing specialist, product development, product manager, project manager, supply chain

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