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Utilize standard engineering principles to resolve difficult problems, from conception to final design with team input.
Support and lead oversight of analytical method lifecycle during clinical and commercial stages from initial delivery through routine use, replacement and obsolescence.
Ability to operate in a team environment and adapt to fast changing business priorities and projects.
Coordinate and consult with grl and other departments on the content, preparation and assembly of regulatory documentation in support of us filings
Working with cross functional groups in each department supporting manufacturing operations within the Lexington Site organization.
The incumbent will manage change controls for the CMC regulatory affairs group for all biological, plasma and/or small molecule products.
Serve as a liaison between the network project teams and the gra cmc product lead. Maintain up-to-date knowledge and expertise of relevant fda and ich guidelines and regulations.
Responsible for contributing to the production of accurate and timely reporting of monthly / quarterly / annual results at the group level.
Responsible for achieving sales quotas through driving new patient starts and the direct sale of GLASSIA, ARALAST NP. Implement sales strategies to attain sales volume, product mix and profit objectives.
As a change agent, works with a cross functional team to develop and deploy new business process and improving existing business processes.
Erroneous decisions can result in critical delays in schedules and / or unit operations and may jeopardize overall business activities.
Lead project execution activities and oversee the development of statistically sound design verification protocols/reports and design validation.
Work closely with the members from alpha 1 sales and marketing team as well as head of alpha 1 marketing to ensure marketing plans align with immunology franchise strategies.
The Network Solutions Engineer Manager provides expertise in data and voice communications and is responsible for the design, implementation, and delivery of effective and secure network.
Assess issues and develop resolutions to meet department objective, which include safety, quality, cost, delivery.
Design and execute strategy for the required data necessary for inds, impds, ctas as well as nda, bla, maa and life cycle management of all globally for small molecule and biologic drug products
Manage tech transfer activities with coordination across technical teams and activities; manage technical interaction with external technical functions.
The GPM role requires a talented individual with proven expertise in leading cross-functional teams and driving product strategy, planning and program execution.
Serve as risk management subject matter expert (sme) on cross functional teams and interface with other shire functional groups including regulatory affairs, clinical development, medical affairs, quality business units, as needed
This candidate will also manage CROs to provide analytical support needed for project teams.
Identify and implement improvement initiatives to improve yield, reliability, and/or process robustness. This may require leading and implementing change controls.
The MSL maintains personal expertise in relevant disease areas and MSL best practices that can be applied externally and internally.
Encourages an environment leading positive performance among colleagues and internal customers, and supports both individual and overall program success.
Provide scientific liaison support to Investigators currently involved in the Company sponsored interventional or observational studies and investigator initiated research
RBM must be able to analyze local and regional business/managed markets trends in order to build both long and short terms goals that lead to a successful business plan.