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Reference Number:
RegulatoryAffairsPM-TOCA
Job Description:
Our major biotech client is looking for a Project Manager for 1 YEAR positions in Thousand Oaks, CA.
**Client is looking for candidates with traditional project management experience in the pharmaceutical industry. Ideally candidates that have managed project deliverables with cross functional participation, using various PM tools. Also need good familiarity with pharmaceutical drug development.**
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
Requirements:
? 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
? Execution of multiple major projects in a matrix environment
? Project management
? Industry and/or Regulatory/Safety experience
? 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
Qualified candidates should please send a MS Word copy of their resume to manisha.jb@sunrisesys.com. PLEASE INCLUDE THE JOB REF # "RegulatoryAffairsPM-TOCA" IN THE SUBJECT LINE!
Experience Level:
Unspecified
Requirements:
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