CMC Project Manager

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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