Delivers effective support to R&D leadership in a timely manner, maintains business critical sources and licensing, analyzes/compiles data, and drives project deliverables.
Establishes and maintains three or more unique sources of supply for Brand comparative products to support 50-70 bioequivalence clinical studies per year within established budget and scheduling guidelines. Performs SAP functions including Requisitions, Invoicing & Service Entry Sheets for the purchase of RLD/Brand, API Excipients & Outside Services.
Performs typical administrative tasks such as calendar management, setting up conference calls, filing, time & attendance, writing/editing correspondence, processing invoices, taking minutes and tracking items due from staff. Coordinate travel arrangements and expense reporting, as well as scheduling meetings to assure timely and effective communication.
Serves as primary contact for all levels of R&D management and staff; professional interaction with top management both within the U.S. and internationally. Independently researches, prioritizes and follows-up on multiple incoming issues and concerns addressed to the R&D Leadership Team, including those of a sensitive nature and propose an appropriate course of action.
Facilitates the US entry of R&D and Launch APIs from off-shore manufacturers into the US by optimizing and executing “End User Letters” to the FDA Import office and API manufacturers.
Compiles information and analyzes complex data to develop presentations and reports, using a variety of software alternatives and creativity, to support the R&D Leadership Team.
Plans and coordinates successful internal and external organizational events to include: staff meetings, management retreats, and others as requested. Creates, updates, maintains, and distributes site organizational charts, utilizing current company policies and procedures, for compliance.
Interacts independently with internal and external Legal staff to support ongoing Paragraph IV litigation logistics. Assesses the degree of urgency and importance of key business areas in order to facilitate communication appropriately between parties. Failure to do this well could lead to litigation delays that could jeopardize launch of new product and loss of sales.
Drives efficiency and compliance through process excellence initiatives as project owner in partnership with the Operational Excellence (OpEx).
Other duties as assigned.
Bachelor’s Degree or a minimum of 5 years progressively responsible business and technical experience in lieu of degree requirement.
Demonstrated strong computer skills with proficiency (advanced level) in Microsoft Word, PowerPoint, and Excel, with a strong, demonstrated working knowledge of SAP.
Some travel domestically may be required.
Demonstrated ability to maintain the highest level of confidentiality and exercise sound judgment in difficult situations.
Ability to work independently to prioritize and handle multiple, simultaneous and complex tasks and projects.
Project management skills, to include organizing, prioritizing and scheduling work assignments.
Excellent organizational skills with the ability to anticipate and plan.
Excellent verbal and written communication skills and the ability to work with a wide range of co-workers in a diverse community.
Demonstrated ability to be resourceful, creative and committed to getting the job right the first time, with a “can do” attitude.
Basic financial competency and familiarity with finance terminology is preferred.