•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 acute pain control and veterinary medicine use.
Essential Duties and Responsibilities
• Oversee all aspects of multiple contemporaneous project(s) including RFP development, proposal review and evaluation, budget development and management.
• Identify and quantify program and project risks such as budgetary, timing, deliverables.
• Support the clin-epi team with epidemiological knowledge and insight.
• Coordinate and liaise with multiple scientific vendors; work with diverse and cross functional teams
• Prepare and review documents for regulatory submissions.
• Contribute to the development of ICH Common Technical Documents (CTD).
• Manage citation libraries and experience with software (EndNote and Reference Manager).
• Write search strings for optimal and focused citation/data retrieval (PubMed).
• Knowledge of clinical and epidemiological studies with emphasis on interpretation of medical research articles focused on clinical outcomes, bioavailability and bioequivalency studies.
• Understanding of the FDA NDA and ANDA processes and ICH Common Technical Documents (CTD).
• Methodological knowledge of and experience with rigorous systematic literature reviews.
• Ability to develop, manage, coordinate and exploit citation databases.
• Exceptional organizational, writing and numeracy knowledge and skills; attentive to detail and output optimization.
• Program information / communication management.
• Data savvy and data management.
• Electronic filing system and directory design and management.
• Scientific and regulatory document development.
• Skilled listener.
• Operations management and the ability to manage multiple time-sensitive components simultaneously.
• Software: MS Office with emphasis on Excel, reference management software, statistical software (a plus), project management software (e.g., MS Project).
• Master’s degree in epidemiology or related field required.
• Experience in evidence based medicine and clinical epidemiology. Pharmaceutical industry experience, a plus.
• Ability to multi-task and successfully handle multiple priorities simultaneously.
Physical Environment and Physical Requirements
• 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.