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Authors regulatory submission documents for New Drug Application (NDA)/Abbreviated New Drug Application (ANDA), supplements, annual reports and Investigator Responses (IR)/Complete Response Letters (CRLs), covering pharmaceutical development and manufacture, including product development reports.
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Represent Lab QA in risk assessment activities for Drug Substance, Drug Product, and Analytical Development. Specifically, this position will provide quality oversight on our state-of-the-art analytical capabilities, clinical assay development and validation, biomarker assay validation and clinical product testing to support both viral vector manufacturing and clinical development.
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At least 2 years in drug development industry in oncology and with previous exposure to clinical development and regulatory documents such as, e.g., (co-)authoring and reviewing of documents such as clinical trial protocols, IB, ICF, CSR.
$301,000 - $355,000 a yearExpandUpdated Yesterday - UpvoteDownvoteShare Job
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The primary role of the QC Senior/ Principal Scientist is responsible to provide analytical support for GMP manufacturing and process development. The QC scientist will develop, qualify, and execute analytical test methods for raw materials, highly potent APIs, antibody-drug conjugates (ADCs), and other pharmaceutical products in a GMP setting.
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We are seeking Senior Associate, Portfolio & Project Management Business & Program Support, to support leaders working on our clinical drug development programs. Basic knowledge of drug development is a plus.
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Perform legal research with respect to pharmaceutical sales and marketing practices as well as the statutes, regulations and guidance documents applicable to these activities (e.g., the Food, Drug and Cosmetic Act, regulations and guidance documents; federal and state anti-kickback statutes, regulations and OIG guidance documents and opinions, PhRMA Code, and related policies and guidelines) as well as Delaware/New York corporation law.
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Collaborate with Pharmacy Manager and CNO in the development and maintenance of the Infusion Department Nursing Training Manual including, ensuring the manual is regularly reviewed and remains up-to date.
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Evotec is a leader in the discovery and development of novel small molecule drugs with operational sites in Europe, Asia and the US. The Company has built substantial drug discovery expertise and an industrialized platform that can drive new innovative small molecule compounds into the clinic.
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Candidates will support key educational outreach initiatives, projects and pilots with agencies including, but not limited to U.S. Customs Border Protection (CBP), U.S. Food and Drug Administration and the U.S. Department of Agriculture.
Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization.
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Possess a general understanding of clinical trials, the drug development process, and ICH GCP regulations. Set-up and management of the Trial Master File (TMF) for assigned study/studies, as appropriate.
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From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved.
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Candidate will be required to work closely with internal R&D teams across all departments such as Clinical Development, Clinical Operations, Biometrics, Regulatory Affairs, Drug Safety and Pharmacovigilance, Translational Sciences, Program Management, and Medical Affairs.
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The North America organization includes three offices (in New Jersey, North Carolina and California) that focus on drug discovery, product development, manufacturing and commercialization.
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Serve as clinical pharmacology lead and pharmacometrics representative on multiple project teams and support model-based drug development strategies for ongoing projects. Great working knowledge of formulation development, drug development and clinical development.
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drug development jobs in Princeton, NJ
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