Job details
Posting date: Jan 9, 2014
Location: South San Francisco, California
Job ID: 00427807
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Company: Genentech
Objectives and Scope of Position:
·
Responsible in conjunction with the iPODD US
Partner for regional (US) cross-portfolio, regulatory strategic and operational
management of Pediatric Study Plans (PSP) for Oncology
·
Primary Responsibilities and Accountabilities:
·
Supports US Partner in his/her responsibilities
of managing Paediatric Study Plans (PSP) for oncology
·
Represents the regional function (US) on the
iPODD (innovative Paediatric Oncology Drug Development) Team.
·
Works in close collaboration with the US
Pediatric Partner, the molecule-specific US partners, and GRLs for the
development and implementation of a US regulatory portfolio strategy for
paediatric oncology projects.
·
Takes lead and coordinates PSP preparation and
submission and manages the procedures on behalf of iPODD Team, with input from
the Project or Life Cycle Team who is accountable for the development strategy
·
Prepares integrated plans relating to regional
PSP submissions and leads the preparation in response to questions from US
regulatory agency related to PSPs
·
Analyses regulatory environment regularly and
proactively updates the iPODD Team, molecule-specific RAFT, Project or Life
Cycle Teams and PDR management for any potential impact on pediatric
project/plans, as appropriate.
·
Gives specific guidance on pediatric regulatory
issues such as legislation, guidelines, and procedures to the iPODD Team, the
molecule-specific RAFT and Project or Life Cycle teams.
·
Participates in and/or otherwise leads other
special projects and initiatives, especially related to pediatric oncology.
Job Requirements:
- General knowledge of regional regulatory processes and experience of successful management of PSP submissions is preferred
- Practical experience of successfully managing Health Authority interactions, especially related to pediatrics issues is preferred (e.g. FDA, PeRC)
- Takes lead in operational excellence to effectively manage PSP preparation, submissions and procedures
- Takes responsibility to analyse issues especially pediatric related matters thoroughly and proposes solutions with solid rationale
- Analyses and understands the competitive landscape especially current and historical pediatric regulatory environment and its impact on assigned products
- Demonstrated excellence in the core competency areas of leadership, influence management, change management, customer focus/business focus, innovative/creative thinking, job knowledge, interpersonal/communication skills, global teamwork, coaching/mentoring
- Influences individuals who may have different interests or goals to reach consensus and achieve team objectives.
The next step is yours. To "Apply online" Visit http://www.gene.com/careers/find-a-job/apply?job_id=00416209
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