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Responsible for development and preparation of technology transfer/process validation protocols and "hands-on" startup of production processes with operators.
Lead the commercial marketing teams across the portfolio to develop the interactive strategy and investment plans to support business growth leveraging social, digital, e-commerce platforms and help bring those strategies to life.
Manage and integrate various global and North American research sources to develop category insights that feed into retailer solutions.
Ensure all staff are adequately trained on all cGMP manufacturing operations and documentation.
Ability to build credibility and presence with customers at all levels of support.
Develop presentations, manuscripts, registry summaries and promotional pieces to communicate/disseminate health outcomes data.
Develop and motivate collaborators (within RA team) to achieve quality output, accountability and recognition across the organization and towards the regulatory authorities.
Participates in the design and interpretation of results from medicines development program.
Lead the software development and software verification and validation per ISO / EN 62304.
Actively participate in Medical Information Workstreams to develop best practices, ways of working and continuous development and improvement for Medical Information deliverables.
The candidate will be responsible for authoring technical reports, technology transfer documents, and CMC sections for regulatory filings.
Ability to challenge and contribute to a science driven culture that delivers quality targets, leads, and candidate drug molecules.
To develop creative solutions to applied problems, To collaborate well with scientists from other disciplines.
Coordinating and leading the development, validation, analysis, interpretation and utilization of instruments aimed at measuring COAs in the context of clinical trials and/or observational studies.
Execute shelf strategy schematics utilizing Apollo, ProSpace, Galleria and / or other space planning software.
Drive the tactical implementation of the strategy to provide Quality Assurance Assessments of team and communicate results of quality monitoring to management.
In collaboration with Regulatory and Commercial, establish diagnostic strategies at the pipeline and project level.
Demonstrable evidence of statistical innovation and technical statistical strength, including publication in major scientific journals .
Develop the predictive chemistry algorithms from high-throughput chemistry data sets and automate the predictions for new chemical transformation of the same class.
Responsible for respiratory contract pull-through, solution development, coordinating selling and other activities with the field for assigned IDN customers that may cross multiple geographies.
Guiding the development of global processes and standards that enhance the ability of company to consistently and accurately meet medical information needs of external customers.
Designs and executes studies to discover, understand, model, simulate, and create new drug molecules.
The candidate will be expected to interact on a routine basis with colleagues in downstream process development, analytical methods development, clinical manufacturing groups.
Analyze and determine the tax implications of federal and state tax law changes, assist in evaluating and implementing tax planning strategies, business transactions and other ad hoc requests.
Responsible for supporting the planning and execution of payer access strategies using advanced decision-support analytics.