- Pfizer (New York, NY)
- …+ Document Management functions + Coordinate TMF Lock process & activities across clinical trial portfolio + Identify and resolve operational issues and ... quality requirements across a range of different countries + Clinical Trial Execution + Clinical ...health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations… more
- Merck (Rahway, NJ)
- …The Medical Writing & Disclosure Department of the GCTO (Global Clinical Trial Operations) organization prepares a variety of regulated documentation in ... accuracy. + Familiarity with United States and/or European Union legislation for clinical trial registration and result disclosure . **NOTICE** **FOR**… more
- Pfizer (New York, NY)
- …Medicine Therapeutic Area. Your project management skills will be leveraged to develop clinical trial timelines and oversee budgets for the assigned clinical ... or business required + 10+ years of relevant experience (prior clinical trial , non-interventional study and/or epidemiologic study) **Prior Experience:**… more
- Pfizer (Pearl River, NY)
- …Designs clinical studies to meet the stated objectives of a program. Assures that clinical trial objectives of each study fit with the clinical program ... all the steps in designing and delivering results of clinical trials by applying extensive expertise and in-depth knowledge...to enable quality, compliance and patient safety at the trial , site and patient level. + Accountable for the… more
- Pfizer (New York, NY)
- …cultivates collegial relationships with key clinical experts, academic entities, and clinical trial sites, and uses these relationships to help establish ... for. + Serves as a Medically Qualified Individual (MQI) at Pfizer, reviewing clinical trial data for safety signal identification and tracking. + Provides… more
- Pfizer (New York, NY)
- …* Experience in understanding of key drivers impacting budgets and experience building a Clinical Trial Budget and managing project to budget Skills: * Strategic ... JOB SUMMARY . * Clinical Development expert focused on the execution of...health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations… more
- Bristol Myers Squibb (Madison, NJ)
- …aligned medical communications plans; adjust communications plans in accordance with clinical trial results/milestones and changes in the healthcare landscape ... of medical communication plans. This role will ensure the disclosure of the science and health economic value of...and ISMPP active member highly desired + Understanding of clinical trial design and execution, statistical methods… more
- Pfizer (New York, NY)
- …communication of statistical analyses, data presentations, and scientific reports, including clinical trial results, exploratory and meta-analysis results **,** ... + A minimum of 4 years' experience in the clinical trial setting (preferably in oncology of...health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations… more
- Pfizer (Pearl River, NY)
- …may contribute towards providing medical and scientific expertise and oversight for Clinical Trials. + The clinician medical monitor may be required to design ... to enable quality, compliance and patient safety at the trial , site and patient level. + Ensures development of...Review Team to evaluate medical benefits/risks to support targeted clinical indications. + Reviews literature as needed to respond… more
- Pfizer (New York, NY)
- … research, knowledge of Good Clinical Practices + Familiarity with clinical trial execution, working with contract research organizations, budget management, ... of knowledge in the areas of Pfizer historic study performance data, competitor trial performance, real world data, and industry benchmarks using a variety of… more
- Pfizer (New York, NY)
- …to ensure global reimbursement and access requirements. Provide strategic input into clinical trial designs (eg, patient populations, comparators, endpoints) and ... patient-reported outcomes strategy and incorporate humanistic and economic endpoints into clinical trials across all phases of product development to build… more
- Pfizer (New York, NY)
- …Area Medical / Clinical / Scientific Conferences/Congresses, KOL Panels and Clinical Trial Steering Groups, in order to maintain and build relationships ... by an extensive pipeline of over 50 programs in clinical development. + The Breast TA Medical Head will...health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations… more
- Pfizer (New York, NY)
- …ICH, and National regulations). **ROLE RESPONSIBILITIES** + Assesses compliance of GCP clinical trial sites and processes against ICH GCP and applicable ... specialty (eg gene therapy) and/or audit topic (eg data management, remote trial methodology etc.) + Candidate demonstrates a breadth of diverse leadership… more
- The Mount Sinai Health System (New York, NY)
- …color * Supportive and experienced clinical staff * State of the art clinical trial unit, clinical and translational research environment and affiliated ... candidates, given that our department is a leader in clinical and translational research in skin of color to...in Cosmetic procedures and Lasers is a plus **Salary Disclosure Information:** Mount Sinai Health System provides a salary… more
- The Mount Sinai Health System (New York, NY)
- …* Supportive and experienced clinical staff * State of the art clinical trial unit, clinical and translational research environment and affiliated ... scholarship.** Our department is experiencing an incredible time of clinical and academic growth. We have been ranked by...in Cosmetic procedures and Lasers is a plus **Salary Disclosure Information:** Mount Sinai Health System provides a salary… more
- The Mount Sinai Health System (New York, NY)
- …* Supportive and experienced clinical staff * State of the art clinical trial unit, clinical and translational research environment and affiliated ... dermatologist with a strong academic record of accomplishments and/or academic, clinical and research productivity, impressive publications and a deep interest in… more
- Pfizer (New York, NY)
- …expansions, trial design and optimization, and other real world clinical studies to further understand burden of disease and effectiveness of vaccines ... with a variety of stakeholders including pipeline/asset teams (eg, Early Clinical Development pipeline teams, Global Product Development franchise/asset teams, BU… more
- Pfizer (New York, NY)
- …with internal/external stakeholders. + Advanced knowledge, experience and expertise in clinical trial development, and operational quality management disciplines ... oncology portfolio. + Responsible for ensuring Level 1 GCP quality for clinical development programs within Pfizer Oncology R&D by establishing a quality framework… more
- Pfizer (Pearl River, NY)
- …all other regulatory agency requirements. + The candidate will receive samples from clinical trial sites and enter samples into an electronic database management ... in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities… more
- Pfizer (New York, NY)
- …+ In depth understanding of the business of pharmaceutical medicine including clinical trial design, GCP and data interpretation, drug development, regulatory ... outcomes and create business impact. + Degree in Computer Sciences, Statistics, Clinical Informatics or similar + Relevant certification &/or work experience in data… more