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Position Summary:

Assures high quality professional Project Management
to a portfolio of R&D projects. Manages ad hoc
assignments in support of the overall international
project planning workload. Assist project Team Leaders
in providing leadership to the matrix teams charged
with the development of new drug development
international programs. Monitors the day-to-day
interactions with project core and ad hoc team
members from R&D functions (Discovery &
Development, Medical Affairs, Regulatory Affairs)
and Marketing, Sales, Finance, Manufacturing,
Outside Contractors, etc.

Principal functions include:

Coordination of the preparation of drug project
development plans that cover all phases from
inception through launch and support to marketed
product, the associated costs, resource
requirements, issues, etc.

Monitoring of day-to-day project activities to ensure
the achievement of all project milestones, on time,
and within the budget. Serves in a mentor role
for team members as required. Facilitates resolution
of team conflicts.

Preparation and distribution of periodical reports
on projects according to guidelines.

Clear and timely communication of project issues
to all involved, orally, and/or via periodic or written
memos as required.

Coordination and development, as required, of
resource allocation data via interaction with the
departments for input to the Project Information System.

Continuous improvement of the project management
process to ensure minimum time to market.

Contribution to the definition of international project
planning policies, guidelines and tools.

Duties and Responsibilities

Coordinate the team effort to develop and circulates comprehensive Project Global Development Plans that integrate the pharmaceutical sciences, clinical
development and/or package design, production, key assumption, strategies, etc. and accurately reflects
the status of the project budget and targeted
completion dates.

Monitors day-to-day activities to ensure that time and
cost commitments are met.

Proactively works to ensure team unity and serves
as a mediator when appropriate to resolve
issues involving team members.

Conducts periodic and ad hoc project team
meetings. Prepares accurate meeting minutes
to communicate project status, direction, agreed
upon action items, and key milestone dates
for each project.

Prepares project timelines that contain all activities, resources, and costs to accomplish key milestone
dates for integration into the project schedule for
use in Project Information System.

Develops communication mechanisms to notify
appropriate decision makers of project requirements
that may be impacted by resource limitations, priority conflicts, etc. resulting in potential delays in commitments.

Maintains an understanding of contemporary project management techniques, regulatory policy, and medical practice, as they impact pharmaceutical development.

Maintains the ability of an expert use of main office automation software packages as well as specific
softwares for project management.

Contribute to develop and maintain a project information system that contains accurate up to date data that
is utilized to respond to ad hoc requests for information
and for use in the preparation of periodic monthly
and quarterly reports.

Represents the project team leader as necessary
at impromptu or routinely scheduled international management and US review meetings.

REQUIREMENTS

An undergraduate degree in Chemistry, Pharmacy, Engineering, etc. (graduate training in business and/or science is preferred).

Very strong analytical, organizational, interpersonal, and written skills.

A minimum of eight years experience of demonstrated leadership ability in a project management and/or
supervisory position.

A minimum of eight years experience working with
matrix teams, five of which in the pharmaceutical industry.

An in-depth knowledge of regulatory environment
impacting pharmaceutical development programs,
e.g. GMP’s, GCP’s, NDA submission, ICH, etc.

Proficiency with Windows ‘98, Microsoft Office
and associated modules (word, excel, access, etc.), Microsoft Project ‘98, and the use of the Internet.

Proficiency with financial controls, budget, management
of expenses, financial projections, cost estimation (expense/capital/unit cost), and cost efficiencies.

Proficiency with resource and activity planning on a
multi project level using contemporary software.