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Project Manager (Regulatory Submission and Documentation)

NETPACE, INC. – Foster City, CA

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The Regulatory Documentation and Submissions (RDS) department works as a global team to drive and innovate document and submission strategy, as well as training and education excellence. The department is made up of four individual departments including Quality, Medical Writing, Disclosure and Transparency, and Regulatory Operations. The Quality department provides various services including, but not limited to: process improvement support, quality reviews (data/content verification and consistency, style application, editing), audit readiness support, and compliance monitoring to support a wide variety of regulatory submissions across all therapeutic indications.
Specific Responsibilities:
* Expands development and support of the software/platform (KaiNexus) utilized to manage small to mid-level departmental improvement initiatives.
* Performs independently as executing Project Manager for improvement initiatives.

Essential Duties and Job Functions :

  • Works with project lead and stakeholders to ensure project framework, objectives, and milestones are aligned with business objectives.
  • Schedules and runs project team meetings, creates meeting minutes, develops next steps/action items, and updates and captures all project artifacts in KaiNexus.
  • Works to obtain stakeholder alignment and feedback ensuring productive meetings and initiatives remain on track and within target
  • Monitors the progress of all initiatives within KaiNexus to ensure timelines are met and project remains within scope.
  • Generates progress reports of all ongoing and planned initiatives utilizing tools in KaiNexus.
  • Proposes and implements plans to resolve complex issues and executes corrective actions.
  • Drives continued team progress on multiple projects during and between meetings through meeting follow-ups, conversations, and emails.
  • Develops features within KaiNexus to ensure platform meets the needs of RDS tracking and reporting
  • Assists in the development of training tools for RDS users.

Knowledge, Experience and Skills :

  • Fluency in project management platforms/software
  • Familiarity with highly regulated industry environments or drug development
  • Excellent program and project management, consensus-building, and leadership skills
  • Exceptional verbal and written communication skills and interpersonal skills.
  • Ability to collaborate across the organizational hierarchy and cross-functionally
  • Experience managing teams in a business operations or technical processes environment
  • Has developed organizational skills; is detail oriented; and able to work in a fast paced, deadline-driven environment.
  • Ability to work independently on basic job duties and understands criticality and time expectations of assigned activities and prioritizes as appropriate
  • Displays flexible thinking and willingness to adapt to changing approaches based on project needs and expectations.
  • Is capable of using advanced functions of various software applications, particularly the Microsoft Office Suite, Adobe Acrobat, and SharePoint

Typically requires: * A BS degree * 5+ years of relevant experience with a Bachelors Degree

  • 2+ years of experience in the biotechnology or pharmaceuticals industry * Familiarity with KaiNexus or similar platform
  • Experience with Six Sigma or other process improvement methodologies
  • Experience managing and collaborating with virtual or remote teams
  • Experience with SharePoint administrator activities

Job Type: Contract

Salary: $55.00 to $65.00 /hour

Experience:

  • Six Sigma or other process improvement methodologies: 3 years (Required)
  • Regulatory Documentation and Submissions: 6 years (Required)
  • biotechnology or pharmaceuticals industry: 3 years (Preferred)
  • KaiNexus or similar platform: 3 years (Required)

Contract Length:

  • 5 - 6 months

Contract Renewal:

  • Likely

Full Time Opportunity:

  • No

Work Location:

  • One location

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