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Luitpold Pharmaceuticals, Inc., a Daiichi Sankyo Group
Company, is dedicated to the development and marketing of
innovative, quality drugs and medical devices for healthcare
professionals, clinics, and hospitals across the United States
and Canada. We specialize in sterile injectables, bone
regeneration materials for dental procedures, as well as
innovative products for veterinary medicine use.
Essential Duties and Responsibilities
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Oversee all aspects of multiple contemporaneous project(s)
including RFP development, proposal review and evaluation,
budget development and management.
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Identify and quantify program and project risks such as
budgetary, timing, deliverables.
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Support the clin-epi team with epidemiological knowledge and
insight.
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Coordinate and liaise with multiple scientific vendors; work
with diverse and cross functional teams
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Prepare and review documents for regulatory submissions.
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Contribute to the development of ICH Common Technical
Documents (CTD).
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Manage citation libraries and experience with software (EndNote
and Reference Manager).
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Write search strings for optimal and focused citation/data
retrieval (PubMed).
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Knowledge of clinical and epidemiological studies with
emphasis on interpretation of medical research articles
focused on clinical outcomes, bioavailability and
bioequivalency studies.
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Understanding of the FDA NDA and ANDA processes and ICH Common
Technical Documents (CTD).
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Methodological knowledge of and experience with rigorous
systematic literature reviews.
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Ability to develop, manage, coordinate and exploit citation
databases.
Other Responsibilities:
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Exceptional organizational, writing and numeracy knowledge and
skills; attentive to detail and output optimization.
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Program information / communication management.
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Data savvy and data management.
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Electronic filing system and directory design and management.
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Scientific and regulatory document development.
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Skilled listener.
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Operations management and the ability to manage multiple
time-sensitive components simultaneously.
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Software: MS Office with emphasis on Excel, reference
management software, statistical software (a plus), project
management software (e.g., MS Project).
Qualifications and Requirements
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Master’s degree in epidemiology or related field required.
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Experience in evidence based medicine and clinical
epidemiology. Pharmaceutical industry experience, a plus.
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Ability to multi-task and successfully handle multiple
priorities simultaneously.
Physical Environment and Physical Requirements
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While performing duties of the job, incumbent is occasionally
required to stand; walk; sit; use hands to finger, handle or
feel objects, tools or controls; reach with hands and arms;
balance; talk and hear.
We are an Equal Opportunity Employer and all qualified
applicants will receive consideration for employment without
regard to race, color, religion, sex, national origin,
disability status, protected veteran status, or any other
characteristic protected by law.
Please apply directly thru our website :
www.luitpold.com,
job # 1741
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