Position Details:
Client Direct Client
Location Lexington, MA
Job Title CMC Project Manager I
Duration 10 Months+
Must have skill-set [Job Description] Requirements
• Working with transition team lead apply standardized project tools to manage and document CMC Regulatory Submission transition project progress towards end goals.
• Facilitate project goals and objectives definition with the team and sponsors.
• Update progress against set milestones.
• Keep current development strategies, integrated plans, communication and risk management plans.
• Document scenario planning to support timely decision making to ensure execution per plans. Ensure effective communication and coordination of deliverables.
• Work with management or team leader to set agendas, plan activities and facilitate decision making.
• Coordinates team logistics including meeting schedules, meeting materials (agendas, pre-read materials, minutes) and ensures adherence to team goals/objectives.
• Facilitates timely and productive team discussions.
Essential Responsibilities
• Support the planning phase and map the transition of CMC Regulatory submission team capturing deliverables, milestones, risks and mitigation plans, priorities, timings, communication strategies, training requirements, resourcing and budgetary requirements.
• Engage with key stakeholders for input and endorsement as necessary and communicate on progress
Experience Requirements
• Pharmaceutical industry and specifically within a CMC/Project Management environment
• Change management experience
• Familiarity with global CMC submission filings
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