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Novartis Oncology
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5/27/2016
Novartis Oncology
East Hanover, NJ

Ensures business owners clarify and/or define sustainable business rules that are consistent and comply with relevant federal, state, and other regulatory requirements, as well as NPC policies and industry standards (e.g., PhRMA Code)Ensures business...

5/27/2016
Novartis Oncology
East Hanover, NJ

Responsible for all statistical tasks on the assigned clinical trials: clinical trial design/planning, analysis plan, reporting activities including exploratory analyses, and additional analysis to support publications. Provide statistical...

5/27/2016
Novartis Oncology
East Hanover, NJ

Designs, plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy, and marketability of pharmaceutical and/or biological products. Uses sound...

5/27/2016
Novartis Oncology
East Hanover, NJ

1. Production of high quality clinical documentation: Clinical Study Report, Risk Management Plan, CTD submission documents (summary of clinical efficacy and safety, and efficacy and safety updates).2. As a member of the submission teams provide...

5/27/2016
Novartis Oncology
East Hanover, NJ

The Global Program Regulatory Manager works with some independence under limited supervision to provide strategic and operational regulatory direction and may support the GPRD for programs through development, registration and approval/post approval....

5/27/2016
Novartis Oncology
East Hanover, NJ

Job Purpose:Responsible for supporting, under the leadership of the Clinical Trial Head (CTH), all aspects of clinical trial(s) and program level activities as assigned.Major Accountabilities:1. Support CTH in ensuring all trial deliverables are met...

5/26/2016
Novartis Oncology
East Hanover, NJ

1. Design and coordinate pharmacokinetic / DMPK related elements for preclinical and/or clinical projects. Identify potential project hurdles, suggest solutions and establish con-tingency plans. Represent OCP on a Global Program Team(s) or early...

5/26/2016
Novartis Oncology
East Hanover, NJ

Responsible for all statistical tasks on the assigned clinical trials: clinical trial design/planning, analysis plan, reporting activities including exploratory analyses, and additional analysis to support publications. Provide statistical...

5/20/2016
Novartis Oncology
East Hanover, NJ

Support operational and some scientific aspects of global oncology clinical trial(s) and program level activities as assigned, under the management of the Clinical Trial Head (CTH).1. Support CTH to ensure all assigned trial deliverables are met...

5/20/2016
Novartis Oncology
East Hanover, NJ

Serves as scientific safety leader for assigned Novartis projects/products. Once the project team is formed, responsible for the integration, analysis, and interpretation of safety information from all sources, including preclinical through lifecycle...