- J&J Family of Companies (Titusville, NJ)
- …medical safety, pharmacogenomics, early clinical development, clinical pharmacology, data science, digital health, global clinical operations, health ... demonstrated ability to develop clinical development plans meeting the highest standards is required. + Global registration experience strongly preferred, as… more
- Bristol Myers Squibb (Princeton, NJ)
- …providing support across program(s) + Serves a key role in the implementation of the Global Clinical Development Strategy for the assigned book of work within an ... including but not limited to + Protocol development + Clinical data review + Data ...of standards across programs and/or indications (eg data standards , programming specifications, statistical analysis plans)… more
- Sanofi Group (Morristown, NJ)
- …and career development goals **(10%) Regulatory Responsibilities** + Reviews and validates clinical data compliance with FDA, EMA, and ICH regulatory ... standards through weekly data review meetings + Coordinates registrations, label submissions, and...company representative + Monitors timely submission and dissemination of clinical data according to regulatory timelines +… more
- J&J Family of Companies (Spring House, PA)
- …Drive operational frameworks for biomarker assay development, validation, and deployment in clinical trials. + Lead global cross-functional teams to integrate ... with global regulatory requirements, ICH GCP, GLP, and quality standards for biomarker and diagnostic deliverables. + Provide direction and oversight of… more
- Lilly (Boston, MA)
- …research/drug development in academia or industry including the design and implementation of large global clinical trials. + Minimum of five years experience in ... external forums where standards , common protocols, assessment instruments, regulatory standards and clinical practice guidelines relevant to women's health… more
- United Therapeutics (Research Triangle Park, NC)
- … data analysis to drive evidence-based decision making + Collaborate with data management, clinical development and medical strategy personnel to align on ... Are You are a detail-oriented person who has a strong understanding of clinical trial and registry design. You are able to effectively communicate complex… more
- Sanofi Group (Swiftwater, PA)
- …the Job** The Global Medical Writing Franchise Head is part of the Vaccine Clinical Documentation group and will manage a global group of Medical Writers who ... well as internal standards . + Participate in the review of strategic clinical documents (eg protocol ID card, Common Technical Document) prepared by the team to… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …public health standards , you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP ... performance, and drive accountability across regions. + Analyze and interpret global sales data -direct and through distributors-to identify revenue opportunities… more
- J&J Family of Companies (Irvine, CA)
- …management, biostatistics, data programmers, and regulatory affairs + Ensure clinical research studies follow regulatory standards and maintain accurate, ... to ensure accuracy, alignment, and scientific integrity + Analyze and interpret clinical data ; effectively communicate data using well-structured tables… more
- Colgate-Palmolive (Topeka, KS)
- …into clinical trial design and implementation, actionable product applications, global nutrition standards , and market-relevant claims. ** Data Analysis ... & Compliance** + Apply your proficiency in ** data analysis methods** relevant to clinical nutrition...research to derive meaningful insights. + Ensure compliance with global regulatory standards related to pet nutrition,… more