- Novo Nordisk Inc. (Boulder, CO)
- …Engineering, or related sciences with 10+ years of relevant experience Proven track record of experience in process chemistry with demonstrated expertise in the ... optimization and scale up of pharmaceutically relevant compounds Well versed in process scale up Ability to develop, mentor and lead process chemistry teams Tech transfer experience Excellent research skills; ability to identify and define problems, develop… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy documents Supervise, review and approval of labeling for marketed products Track applications through FDA reviewing divisions Work with project associate on ... compilation of information and supportive documentation for FDA briefing packages Work with project leader and team to draft FDA meeting requests and supporting briefing packages for FDA meetings (pre-IND, EOP 2, pre-NDA, pre-BLA) for review by Project Leaders… more
- Merck & Co. (Durham, NC)
- …and ability to translate manufacturing requirements into Automation/digital solutionProven track record of analytical skills, problem solving and attention to ... detailAble to demonstrate the our companies Leadership Principles and Enterprise LeadershipHigh personal integrity, credibility, and energyExcellent communication and influencing skillsStrong written and verbal communication skills in English Preferred… more
- Merck & Co. (Durham, NC)
- …a team to ensure reliable maintenance/calibration execution.Assign yearly performance objectives and track metrics for the team in alignment with department and site ... goalsProvide leadership to the team as needed based on the team's capabilities and maturityEnsure on time approval of payroll activities using site approved software like ADP.Lead and support daily meetings to facilitate flow of information up/down through the… more
- Novo Nordisk Inc. (Durham, NC)
- …basis, meets deadlines & makes regular progress reports on performance Keeps track & informs management about fluctuation in workload Performs well with ... multi-tasking Adjust priorities in accordance with changing circumstances We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …leadership meeting, Global QA meeting etc.- Support Head, Global Strategy and Operations to track the objective and the mid-term plan in Global QA to ensure Global ... QA activities globally.- Support Head, Global Strategy and Operations to draft the Global RD/PV/MA QA strategy operation plan with Head, Global QA function to ensure Global QA activities globally.Support Operational activities:- Manage the QA shared point and… more
- Eisai, Inc (Nutley, NJ)
- …execute in an environment under time and resource pressures.Strong track record of effective cross-functional team collaboration and execution.Consistent ... demonstration and embodiment of company core values Collaboration, Excellence, Innovation, Integrity, Passion, Patient/Stakeholder Centricity.Position based in Nutley, NJ with a minimum of two days on-site per week required.#LI-JL1#IND123Eisai is an equal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …4 years in a pharmaceutical industry medical review role required- Proven track record of working successfully with cross-functional teams to achieve results ... required- Comprehensive understanding and application of relevant regulations, policies and guidances is required (eg OIG, FDA, PhRMA Code etc..). required- Experience in people management (formal direct reports and/or coaching/mentoring experience) is… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …activities. Performance Tracking and Monitoring: Develop KPIs and metrics to track business operations processes and strategic initiatives that execute against ... strategic objectives. Prepare regular reports to communicate performance trends, insights, and recommendations. Analytic-Driven Optimization: Utilize data analytics to provide data-driven insights, monitor and evaluate the performance of therapeutic area… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in reviewing & interpreting scientific and study data is required Track record of scientific publications strongly preferred 4+ years Pharmaceutical/Biotech industry ... experience, including time managing clinical trials, or academic clinical research background Working knowledge of biostatistics, data management, clinical operations and scientific and technical processes desirable Working knowledge of applicable US and EU… more
