CMC Project Manager

CMC Project Manager

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas:
Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

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

Key Skills and Competencies

• Strong work ethic and attention to detail

• Ability to work independently and as an integral part of a team, take initiative, and complete tasks to deadlines

• Ability to manage multiple activities, prioritize effectively, and work to aggressive timelines

• Ability to collaborate cross functionally and strong communicator both within line functions and across matrixed teams

Thanks!!!

Warm Regards,

Amrit Singh

Clinical Recruiter

Integrated Resources, Inc

IT REHAB CLINICAL NURSING

Tel:

Fax:

Inc. 5000 - 2007, 2008, 2009, 2010, 2011,  & 2014 (8th Year)

Certified MBE I GSA
- Schedule 66 I GSA
- Schedule 621I I GSA
- Schedule 70

I'm interested