- Fujifilm (Raleigh, NC)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations and standards. + Key Performance Indicators + Effective delivery across the organization for optimal Sales Guided Selling strategies for the North American and Global markets. + Revenue and sales bookings targets met or… more
- BioLife Plasma Services (Charlotte, NC)
- …(in state of licensure) for basic IV therapy + Satisfactorily complete the FDA approved training requirements for BioLife Medical Support Specialist + Two years in ... a clinical or hospital setting **More about us:** ** ** At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and… more
- Cardinal Health (Charlotte, NC)
- …sensitive radiopharmaceuticals in an integrity driven, highly regulated environment (ie FDA , NRC, DOT) to support patient treatment through disease diagnosis, ... staging, and monitoring. The primary work environment consists of a cyclotron and associated manufacturing facility for the production of PET radiopharmaceuticals, which must be kept clean, orderly, properly lighted and maintained in optimum operating… more
- Sumitomo Pharma (Raleigh, NC)
- …and international travel **Key Core Competencies** + Knowledge and understanding of FDA , GCP, and ICH regulations and guidance + Thorough and up-to-date knowledge ... of therapeutic area including trends, advances, understanding of currently available therapies and competitive clinical landscape + Experience in conducting global clinical trials in both early- and late-stage clinical development, especially protocol… more
- ThermoFisher Scientific (Greenville, NC)
- …**Knowledge, Skills, and Abilities** + Advanced knowledge of GMP regulations, FDA guidance, and pharmaceutical quality systems + Strong expertise in batch ... record review, deviation management, CAPA, and root cause analysis + Proficiency with electronic quality management systems and documentation platforms + Strong written and verbal communication skills with the ability to effectively collaborate across… more
- Datavant (Raleigh, NC)
- …alignment with client data strategies, evidence frameworks, and regulatory expectations (eg, FDA , EMA guidance). + **Market Expertise:** Stay current on RWE market ... dynamics, regulatory guidance for real-world data, and competitor offerings to position Aetion as a strategic leader and partner of choice in the evidence generation ecosystem. + **Forecasting & Reporting:** Maintain accurate pipeline management and… more
- Fujifilm (Holly Springs, NC)
- …work is accurate, precise, properly documented, and compliant with SOPs and FDA cGMP guidelines * Assists MSAT process engineers/experts in supporting drug product ... and finished goods manufacturing operations, as applicable * Performs other duties, as assigned **Basic Requirements** * Currently enrolled in an Associate's Degree program with a LifeSciences focus **OR** * Rising Junior or above and enrolled in an… more
- United Therapeutics (Research Triangle Park, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an… more
- United Therapeutics (Research Triangle Park, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an… more
- Mentor Technical Group (Wilson, NC)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six… more