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Extensive experience in late-phase drug product development and commercial development with CMC regulatory filings for the US (NDA), Europe (MAA), Japan, and China. Thorough understanding and working experience of pharmaceutical drug products concerning GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements.
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Playing a critical role as the subject matter expert (SME) and technical lead of Drug Product within PDM function, the position will be responsible for preformulation studies, formulation and process development, drug delivery design, optimization, scale-up and manufacturing in support of Revolution Medicines pipeline compound development and clinical programs.
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Playing a critical role as the subject matter expert (SME) and project lead of Pharmaceutical Development within CMC function, the position will be responsible for preformulation studies, formulation and process development, drug delivery design, optimization, scale-up and manufacturing in support of Revolution Medicines pipeline compound development and clinical programs.
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And minimum 7 years global Drug Safety/Pharmacovigilance clinical trial and post marketing experience in a pharmaceutical or biotechnology industry in positions of increasing technical and leadership responsibility.
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Minimum of Bachelors degree in Life Sciences, Healthcare, or relevant field/ equivalent qualification with 8 years of experience working in Drug Safety/Pharmacovigilance Operations. Prior experience in Pre-marketing Drug Safety/Pharmacovigilance Operations.
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Lead pre-formulation, final form selection, formulation and process development, clinical manufacturing, scale-up, tech transfer, process optimization, and process validation activities related to solid oral dosage and parenteral drug products.
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The Scientist II will provide technical leadership in complex in vivo workflows, identification and validation of new drug targets, advancing novel therapies, and developing technologies to accelerate scientific research.
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Freeport-McMoRan promotes a drug/alcohol-free work environment using mandatory pre-employment drug testing and on-going drug and alcohol testing, as allowed by applicable laws. Freeport-McMoRan promotes a drug/alcohol free work environment through the use of mandatory pre-employment drug testing and on-going random drug testing as per applicable State Laws.
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The Drug Authorization Specialist, with direct supervision of the Prior Authorization Supervisor, is responsible for managing all work related to drug authorizations for all injectable drug treatment plans ordered by Dana Farber Cancer Institute providers using knowledge of payer coverage policies and applies appropriate payer guidelines to all aspects of drug prior authorization work.
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Sail Biomedicines is seeking a highly motivated and innovative Associate Director, Drug Substance Process Development to be the subject matter expert and leader of RNA manufacturing processes, including upstream and downstream activities.
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Interact with and / or supervise Drug Safety / Pharmacovigilance CROs. Senior Director, Drug Safety & Pharmacovigilance. This role allows the incumbent to build the in-house drug safety function in a fast-growing biotech and have the pharmacovigilance responsibility across the proprietary Probody portfolio.
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A law firm is seeking a Senior FDA Drug/Biologics Regulation Counsel to join their team in Washington, DC. The ideal candidate will provide comprehensive legal counsel on FDA regulation matters pertaining to drugs, biologics, cellular, and gene therapy products.
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Averhealth is currently looking for a Female Drug Screening Representative for our Boise testing location. As a Drug Screening Representative, you will be working in a Patient Care Center performing an observed collection of urine samples from our patients.
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A law firm is seeking a Senior FDA Drug/Biologics Regulation Counsel for its San Diego office. 10+ years of industry experience in drug/biologics development. Juris Doctor (JD) degree from an accredited law school.
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Spearhead the development and strategy of our client’s computational platform, integrating novel computational techniques and GPCR structural biology to aid drug discovery and development. Our client is pioneering revolutionary patient treatments through a robust structure-based and computational drug discovery approach.
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drug job Title: apprentice Company: Design Company
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