Job Details

  • Title: Project Manager
  • Code: RCI-3376433
  • Location: Bridgewater New Jersey (NJ) 08807
  • Posted Date: 02/22/2021
  • Duration: 12+ Months
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  Job Description

Summary:

  • Responsible for all aspects of project management for assigned projects.
  • Partnering with the Regulatory Lead and Regional Leads, Program PMO and others PM will translate regulatory activities (global, regional and local) supporting the assigned acquisition or divesture project into meaningful, trackable and executable project plans that align with the overall project requirements and timelines.

Responsibilities:

  • This person will be responsible for the product transfers between two companies post acquisition.
  • The main aspect of the role is to liaise with key RA colleagues, Quality colleagues, Supply Chain / Manufacturing colleagues to ensure identify at a registration and SKU level.
  • Ensuring a registration transfer plan is in place for pharma and devices as per the Product List, with transfer dates determined by the generation of the new legal entity structure.
  • Ensuring the labels of those products which are moving are updated in line with local requirements with no impact to business continuity and with minimal write-off costs.
  • Ensuring the relevant databases and systems house the relevant data and transferred to each company in partnership with our IT colleagues.
  • RA experience would be required due to the impact to the registrations and labeling in markets across all regions (NA, LATAM, ASPAC and especially EMEA)

Additional Responsibilities include:

  • Responsible for end-to-end project planning and delivery of identified key outputs (charter, timelines, etc.), including resource needs and budget requirements.
  • Ensures adherence to overall project methodology.
  • Actively manages action, risk, issue and decision management log(s).
  • Reports on progress and tracking of milestones (Dashboards) within Regulatory and at the Program level.
  • Meeting scheduling prepare agendas and minutes, and track follow-up actions.
  • Challenge the team to be innovative, make it safe to try approaches and take prudent risks.
  • Manage the team in a manner that fosters and maintains a high-performance team culture.
  • Fosters an environment of continuous improvement and shared learning to drive enhancements to the tools and standard timeline templates.

Minimum Qualifications:

  • Bachelor's Degree or equivalent degree is required (Lean Six Sigma – nice to have)
  • Project Management experience or direct working experience in Regulatory Affairs is required
  • Merger, divestiture, and acquisition experience (product transfer) is highly preferred
  • A degree in a scientific or technical discipline is preferred.
  • An advanced degree is preferred.
  • At least 7 years of pharmaceutical or medical device experience is required.
  • Experience with developing and managing project plans is required.
  • Experience working cross functionally within teams including IT, RA, QA, Legal etc.
  • Demonstrated ability to resolve conflict and influence teams without formal authority is required.
  • Successful experience managing, or leading global and/or virtual teams is highly preferred.
  • Record of successful governance body and/or stakeholder management highly preferred.
  • Advanced file share technology skills (i.e. SharePoint) is highly preferred.
  • Experience working with products at SKU level

Preferred Skills:

  • Strong understanding of spine and ortho products
  • Risk analysis experience
  • Labeling experience
  • Lean six sigma
  • PMP