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Certara is focused on the use of model-informed drug development to supplement or replace traditional drug development processes with in silico approaches which include modeling and simulation, clinical trial simulation, real-world evidence generation, paired with extensive drug development, regulatory and market access expertise.
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Week)Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada, and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
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Perform assay development, validation, and sample bioanalysis for preclinical and clinical studies. + at least 1 year of knowledge and hands-on experience in LBA such as ELISA and the application to drug or biomarker concentration measurement as evidenced by laboratory skills.
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MD/PharmD/PhD or equivalent with 10+ years of pharmaceutical/biotherapeutics industry experience•Experience in drug safety, pharmacovigilance, quality assurance and compliance requirements is desirable.
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ADVENT's services include process engineering, automation engineering, project engineering, HVAC/facility system design, process development, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.
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Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies.
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Provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials. Description About the role:Join Takeda as a Senior Manager, US Medical Ad/Promo Regulatory Review where you will serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products.
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The Senior Program Management (Early-Stage Development) will partner with the Development Program Lead (DPL) to lead the Development Program Team (DPT) to successfully shape and execute the project and drug development strategies, as well as, lifecycle plan.
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Commitment to developing and caring for young minds Willingness to participate in continuing professional development CLEARANCES NEEDED (within 14 days) Clear Child Abuse/Police/Drug Screening Clear Physical (every year) Clear TB screening Confirmation of Certificate or Degree ESS Education is acting as an Employment Agency in relation to this vacancy.
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Your expertise will be instrumental in guiding cross-functional teams and propelling Franklin’s mission providing high quality services to further client drug development. Familiar and comfortable with preclinical safety assessment strategies for various drug products, including but not limited to gene therapy products, small molecules or other biologics.
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Knowledge of the drug development process and clinical research methodologies including experience in clinical trial design, data analysis/statistics and data interpretation; knowledge of regulations, ICH/GCP, adverse event management.
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Job Summary The Corporate Development team plays a crucial role in driving the strategic growth agenda of the company through various initiatives including mergers and acquisitions (M&A), partnerships, joint ventures, and strategic alliances.
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The company’s product portfolio includes coatings, drug delivery platforms, mechanical devices, and a wide range of biomedical materials that enable the replacement, repair, enhancement and the regeneration of tissue and organ functions in the body.
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Founded in 2004, Pharmaron has invested in its people and facilities, and established a broad spectrum of research, development and manufacturing service capabilities throughout the entire drug discovery, preclinical and clinical development process across multiple therapeutic modalities, including small molecules, biologics and CGT products.
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Provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials, including representation on global regulatory and labeling teams.
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drug development jobs in Malvern, PA
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