- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Global Team Leader , is a senior, cross-functional leader in Daiichi Sankyo's Global R&D ... In this key role, the candidate will have to lead a complex, global team in charge of a...a complex, global team in charge of a global clinical program designed to support registration and develop value-enhancing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary The Executive Director, Global Clinical Operations Study Management Group Head has leadership and overall strategic ... all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for ensuring the...including time in role such as a Global Project Leader at Sr. Director level or equivalent preferred- Relevant… more
- Insmed Incorporated (Bridgewater, NJ)
- …Associate Director of Biostatistics is responsible for the statistical aspects for complex clinical trial(s) or indication product line . This role leads the ... responsibilities will include, but not necessarily be limited to, the following: Lead complex clinical trials or indication corresponding to one or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …initiatives including but not limited to KOL development, advisory boards, clinical communications and medical education programs Responsible for the development of ... such things as in-depth market analysis, market research activities, thought leader development, HCP and patient marketing, medical education, sample planning… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical Biomarkers, ... all 3rd party data from diverse external providers for clinical trials, companion diagnostics trials, clinical development,...data sets, data structures to ensure delivery is in line with agreed upon EFTs, eDTS, DS External Data… more
- Catalent (San Diego, CA)
- …San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies facility. As a member of the Site Leadership Team, you will partner with ... development, GMP manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit and develop exceptional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …technologies. Lead Lessons learned information flow at the GPT/ Clinical Operations level based on audits, inspections, regulatory intelligence, effectiveness ... as other research areas centered around rare diseases and immune disorders.Summary Lead the implementation of the quality strategy closely aligned with the business… more
- Insmed Incorporated (Bridgewater, NJ)
- …Director of Biostatistics is a highly visible role within the Clinical Development organization and is responsible for the statistical leadership and ... expertise for a product line through the entire development process. This role provides...and leads the statistical design, analysis, and reporting of clinical trials, and interacts with global regulatory agencies. This… more
- Catalent (Philadelphia, PA)
- …room and equipment set up, equipment verification, routine packaging operations, line clearances, room and equipment cleaning activities. The Quality Inspector will ... Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and...your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and… more
- Catalent (San Diego, CA)
- …development, GMP manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit and develop exceptional ... activities including release of GMP materials, shipment verification and performance of line clearances in a Class 100,000 environment, maintenance of clinical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... is able to provide clear direction on Medical Affiars engagement needs to the clinical data science & evidence team and other relevant functions As a senior level… more
- Insmed Incorporated (Bridgewater, NJ)
- …teams, collaborating with subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC, and program management to drive the overall ... the potential impact of toxicology results on Program and Clinical /Regulatory strategy.Author nonclinical sections in regulatory submission documents (eg, IBs,… more
- Catalent (San Diego, CA)
- …including protocols, test methods, master batch records, and specifications for analytical testing. Lead role in onboarding new compounds to the site involving review ... a new compound are considered against site capabilities.Perform internal and external audits. Lead or support client audits along with the Director and Associate… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …operations with a focus on operational excellence in support of patient needs Lead design, implementation and ongoing management of all Rare Disease patient HUB ... and communication of best practices Coordinates agency training in line with business objectives and with input where appropriate...the annual brand planning process with data driven insights Lead and execute ongoing analyses of the market in… more
- Insmed Incorporated (Bridgewater, NJ)
- …teams, collaborating with subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC, and program management to drive the overall ... the potential impact of toxicology results on Program and Clinical /Regulatory strategy.Author nonclinical sections in regulatory submission documents (eg, IBs,… more
- Catalent (Manassas, VA)
- …various internal customers is also essential; Ability to communicate with all line -level positions and management.Attention to detail and self-starter who must be ... your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and...sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more… more
- Catalent (Manassas, VA)
- …communicate effectively verbally and in written English; Ability to communicate with all line level positions and management; Knowledge of spoken Spanish is a plus ... your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and...sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as cross-functional stakeholders (eg, RA CMC, R&D Excellence, Clinical Operations, IT).Responsibilities Operate within and in support of the established ... data governance principles, policies, and standards specific to GRA, in line with corporate data policy.Collaborate with cross-functional stakeholders (incl. RD /… more
- Insmed Incorporated (Denver, CO)
- …mission to transform the lives of patients. They must possess a high clinical aptitude and experience in portfolio selling environment to engage key customers. Along ... role and can be located in or around: Denver preferred.ResponsibilitiesResponsibilities:Develop, lead , and execute a sales plan with specific goals and targets… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Tax. Continual interaction and collaboration with Corporate Tax, Finance groups and Line of Business personnel at NNI and all US affiliates including commercial, ... may support and report into this position. Position leads with indirect line authority. Essential Functions Tax Operations (Commercial): Assist Director of US Tax… more
