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Ref: CS: PM

Senior Project Manager

Mackenzie Stuart is currently working with a global oncology biotech company who are actively seeking a Senior Project Manager.

Responsibilities of the role include, but are not limited to:

  • Work closely with key stakeholders across the organization, including lab operations, marketing, regulatory, quality, medical affairs, , clinical development and bioinformatics teams, among others, to prepare status reports, specific project updates, and scenarios
  • Establish and maintain functionally integrated project schedules and other tracking tools to enable accurate project management across various functional areas
  • Schedule, organize, and drive team meeting(s): prepare and distribute agendas/minutes; track action items, and escalate areas of concern to the appropriate management entity
  • Adhere to design control best practices and engage with functional leads to generate expected documentation throughout product development
  • Lead the team to prepare for design reviews, phase gates and other go/no go decisions required by executive leadership
  • Interact with working group leads and/or SMEs Lead team efforts to mitigate risks and resolve issues quickly as they arise through problem resolution including root cause analysis and corrective action

To be considered for the role you must meet the following requirements:

  • BA/BS in a scientific field is required, while an advanced degree is desirable in a subject area related to device, diagnostic, and/or drug development
  • 10 years multi-disciplinary experience in the device/diagnostic (strongly preferred)/biotech industry, with 3-5 years of direct project management experience on interdisciplinary or cross functional product development teams
  • Extensive experience working under and managing projects through design control
  • Understanding of CLIA/CAP, FDA regulatory processes and prior experience with regulatory filings with Device/Diagnostics

About Mackenzie Stuart Global Executive Search & Selection:
Mackenzie Stuart is a leading executive search and selection business. From our offices in Leeds, London & Toronto we provide retained and contingency recruitment solutions across industry and have specialist recruitment consultants that work within the Oil & Gas, Mining, Infrastructure & Built Environment, Medical & Scientific, Healthcare, Education, Finance & Accountancy, Insurance, Water, Chemicals & Coatings, Ingredients & Flavours, Automation, FMCG and Logistics sectors.

Job Reference: CS: PM

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Salary Range

$0 - 0

Location

USA