|
Reference Number:
DF-PMTO
Job Description:
IF YOU ARE INTERESTED AND QUALIFIED FOR THIS POSITION PLEASE SEND AN UPDATED RESUME IN A WORD DOCUMENT TO danielle@sunrisesys.com I LOOK FORWARD TO WORKING WITH YOU.
Description:
? Serve as project manager for Global Regulatory and Safety function (Global Regulatory, Global Safety, Global Regulatory CMC) deliverables, including:
? Components of marketing applications and maintenance of applications
? Clinical trial applications
? Responses to regulatory agency questions
? Pediatric plans
? Regulatory agency interactions, including briefing documents and meeting preparation
? Other regulatory reports and documents
? Safety reports and documents
? Maintain knowledge of activities in assigned products through review of appropriate team documents
? Provide project management support to CMC Global Regulatory Team, Global Safety Team, and Regulatory and Safety
partnership/emerging market teams including agendas, minutes and action item tracking as needed
? Communicate Regulatory and Safety plans, achievements, and milestones
? Coordinate Safety meeting planning, slide preparation, meeting attendance, communication of outcomes to stakeholders, and follow-up on action items
? Liaise with other project management groups in development, operations, and commercial to ensure alignment of global regulatory and safety plans with other functional plans
? Identify and create communication and issue identification/resolution plans
? Create and manage timelines for Regulatory and Safety deliverables
? Monitor and, as necessary, enter data into tracking systems for Regulatory and Safety deliverables to ensure they are kept current
? Participate as a member of relevant teams
Decision making authority
? Identification of issues for escalation
? Time management across assigned product teams
Outputs
? Project timelines
? Tracking tools
? Plans for Regulatory and Safety deliverables
? Meeting agendas, meeting minutes, and action items
Qualifications
? Bachelors degree, or equivalent combination of education and experience, and a minimum of 7 years relevant work experience
? Masters degree or PMP certification plus 4 years relevant experience
? PMP certification
? Execution of multiple major projects in a matrix environment
? Project management
? Industry and/or Regulatory/Safety experience
Knowledge
? Amgen systems
? Project Management software
? Understanding of Regulatory and Safety functional activities
? Application of project management principles
Competencies
? Action oriented
? Dealing with ambiguity
? Command skills
? Conflict management
? Customer focus
? Managing diversity
? Listening
? Managing and measuring work
? Building effective teams
Experience Level:
Unspecified
Requirements:
|
