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Project Manager

Job Description

Position: Project Manager- Regulatory & Medical Affairs

Duration: 6 month contract

Location: Hopewell, NJ

Functional Area Description The Clinical Trial Business Partnerships (CTBP) department is focused on executing the business' sourcing strategy across all phases of R&D development operations. This group applies a common framework to drive efficient, consistent and compliant processes for vendor relationship and management of BMS' major clinical service providers. Serving as a bridge between BMS' clinical teams and external services providers, the CTBP is responsible for building the appropriate in-house management/oversight structure and mechanisms, while driving the external collaboration with clinical service providers in effort to yield a multitude of innovative ideas to deliver on BMS' goals.

Position Summary / Objective

This position reports to the Associate Director, Global Vendor Oversight & Operations. As an integral member of CTBP, the XXX assists various team members by coordinating tasks related to CTBP business processes.

Position Responsibilities

  • Ability to develop a range of written materials such as detailed instructions for high level principles-based documents
  • Support and manage the completion of deliverable related to audit and inspection corrective and preventative actions
  • Document collection and stewardship
  • Strong GCP and ICH knowledge, including local/regional guidelines which are applicable to clinical research and the regulatory landscape
  • Ability to effectively manage projects, escalate issues as necessary and meet key milestones
  • Ability to lead and facilitate team meetings, that contribute to attaining team goals and resolving complex issues
  • Work with autonomy and is able to able to negotiate and influence others without direct authority
  • Impacts the success of projects to meet short-term objectives & adhere to project schedule
  • Primarily internal communication (limited external)
  • Procedural document (and similar) writing as related to R&D Vendor Oversight Project outputs
  • Audit & Inspection Response support (Infinity and QET management and follow up, etc.) - not authoring the response content
  • CTBP document stewardship - search, collection and reorganization of records in preparation for Enterprise Level controlled repository

Degree Requirements: Bachelor Degree required

Experience Requirements

  • Bachelor's degree with a minimum of 5-10 years' experience in global drug development
  • Demonstrated knowledge of Good Clinical Practice (GCP) ICH
  • Guidelines and applicable FDA regulations
  • Project Management
  • Demonstrated ability to successfully manage competing deadlines and balance priorities while meeting or exceeding expectations
  • Demonstrated success in managing project team effectiveness, through facilitation and presentation skills to a globally diverse audience
  • Document Development and Review:
  • High level of writing competency, specifically in the appropriate use of grammar, syntax and organization of ideas on paper
  • Proactively use judgment and creativity to manage risk and uncertainty, and to anticipate the need for and implement contingency plans

Key Competency Requirements

  • Experience in cross-functional, multi-cultural teams and ability to work within a matrix structure
  • Proven time management skills and ability to be flexible to meet job demands and take on new initiatives and improvement efforts
  • Ability to sustain high levels of performance in a constantly changing environment while supporting multiple projects concurrently
  • Proficient in use of MS Office suite, Veeva Vault platform products, SharePoint, OneNote

Job Requirements

 

Job Snapshot

Location US-NJ-Pennington
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type Pharmaceutical
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Company Overview

AIC (part of ACS Group)

Analysts International Corporation (AIC) is an IT services firm fully dedicated to the success and satisfaction of its customers. From IT staffing to project-based solutions, AIC provides a broad range of services designed to help businesses and government agencies drive value, control costs and deliver on the promise of a more efficient and productive enterprise. Learn More

Contact Information

US-NJ-Pennington
AIC
678-373-4465
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Snapshot
AIC (part of ACS Group)
Company:
US-NJ-Pennington
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Pharmaceutical
Store Type:

Job Description

Position: Project Manager- Regulatory & Medical Affairs

Duration: 6 month contract

Location: Hopewell, NJ

Functional Area Description The Clinical Trial Business Partnerships (CTBP) department is focused on executing the business' sourcing strategy across all phases of R&D development operations. This group applies a common framework to drive efficient, consistent and compliant processes for vendor relationship and management of BMS' major clinical service providers. Serving as a bridge between BMS' clinical teams and external services providers, the CTBP is responsible for building the appropriate in-house management/oversight structure and mechanisms, while driving the external collaboration with clinical service providers in effort to yield a multitude of innovative ideas to deliver on BMS' goals.

Position Summary / Objective

This position reports to the Associate Director, Global Vendor Oversight & Operations. As an integral member of CTBP, the XXX assists various team members by coordinating tasks related to CTBP business processes.

Position Responsibilities

  • Ability to develop a range of written materials such as detailed instructions for high level principles-based documents
  • Support and manage the completion of deliverable related to audit and inspection corrective and preventative actions
  • Document collection and stewardship
  • Strong GCP and ICH knowledge, including local/regional guidelines which are applicable to clinical research and the regulatory landscape
  • Ability to effectively manage projects, escalate issues as necessary and meet key milestones
  • Ability to lead and facilitate team meetings, that contribute to attaining team goals and resolving complex issues
  • Work with autonomy and is able to able to negotiate and influence others without direct authority
  • Impacts the success of projects to meet short-term objectives & adhere to project schedule
  • Primarily internal communication (limited external)
  • Procedural document (and similar) writing as related to R&D Vendor Oversight Project outputs
  • Audit & Inspection Response support (Infinity and QET management and follow up, etc.) - not authoring the response content
  • CTBP document stewardship - search, collection and reorganization of records in preparation for Enterprise Level controlled repository

Degree Requirements: Bachelor Degree required

Experience Requirements

  • Bachelor's degree with a minimum of 5-10 years' experience in global drug development
  • Demonstrated knowledge of Good Clinical Practice (GCP) ICH
  • Guidelines and applicable FDA regulations
  • Project Management
  • Demonstrated ability to successfully manage competing deadlines and balance priorities while meeting or exceeding expectations
  • Demonstrated success in managing project team effectiveness, through facilitation and presentation skills to a globally diverse audience
  • Document Development and Review:
  • High level of writing competency, specifically in the appropriate use of grammar, syntax and organization of ideas on paper
  • Proactively use judgment and creativity to manage risk and uncertainty, and to anticipate the need for and implement contingency plans

Key Competency Requirements

  • Experience in cross-functional, multi-cultural teams and ability to work within a matrix structure
  • Proven time management skills and ability to be flexible to meet job demands and take on new initiatives and improvement efforts
  • Ability to sustain high levels of performance in a constantly changing environment while supporting multiple projects concurrently
  • Proficient in use of MS Office suite, Veeva Vault platform products, SharePoint, OneNote

Job Requirements

 
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Project Manager Apply now