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10+ years of experience in drug safety/pharmacovigilance within global clinical trial settings, with expertise in FDA, EU, ICH regulations, and Good Pharmacovigilance Practice guidelines. 10+ years of experience in drug safety/pharmacovigilance within global clinical trial settings, with expertise in FDA, EU, ICH regulations, and Good Pharmacovigilance Practice guidelines.
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Ensures ongoing compliance with all applicable regulatory agencies for department section (including but not limited to: CLIA, TJC, OSHA, DPH, HCFA, FDA, AABB, NCCLS). Certification by American Society of Clinical Pathologists (ASCP) or National Credentialing Agency (NCA) or equivalent agency as a Medical Technologist, Clinical Laboratory Scientist, Medical Laboratory Technician, or specialty certification is preferred.
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Be accountable for statistical activities in support of IND/NDA/MAA or other regulatory submissions Address statistical questions/comments from FDA, EMA, and other regulatory agencies, and review and address comments by IRB/ECs.
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The Clinical Research Coordinator (CRC) works to ensure the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations, and SOPs. The Clinical Research Coordinator under the direction of the Site Manager/Director and the Principal/Sub Investigators conducts the following according to the study protocol, company processes & procedures, and in compliance with FDA, GCP, and ICH regulations and guidelines.
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Strong knowledge of Bioanalytical Assay Validation regulations (FDA, EMA guidance) Working knowledge of skills in PCR methods, LCMS, Flow cytometry are highly desirable. Moderna’s Bioanalytics group is seeking an Associate Director with strong hands-on experience in ligand-binding assays, including pharmacokinetics (PK), pharmacodynamics (PD), and anti-drug antibody (ADA) assessments, to quantify mRNAs, proteins, and antibodies against therapeutic proteins.
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Knowledge and hands-on experience of the good pharmacovigilance practices and international regulatory requirements such as EMA/FDA/ICH guidelines required. Solid clinical experience from direct patient care (clinical experience and/or board certification in Oncology, Immunology, Genetics desired) and 10+ years of experience in drug development and in drug safety/pharmacovigilance required.
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Demonstrated proficiency in drug safety databases (e.g., Argus), electronic data capture systems, and coding with MedDRA and WHO Drug dictionary. Director/ Senior Director/ Executive Director of Pharmacovigilance and Drug Safety.
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Ensure compliance with FDA regulations and ICH guidelines to meet all regulatory drug safety and pharmacovigilance reporting requirements. Thorough knowledge of relevant FDA and International Conference on Harmonisation (ICH) guidelines required, including Good Clinical Practices (GCP) guidelines.
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At least 4 years of experience working as a Test Automation Engineer, preferably in a regulated environment, e.g., FDA. VideaHealth is supported by some of the best investors in the world, having raised over $27M in Venture Capital from Tier 1 investors such as Spark Capital (Twitter, SnapChat, SmileDirectClub), Zetta Venture (Kaggle), and Pillar VC (PillPack), as well as angel investors such as Frederic Kerrest (Co-founder of Okta.
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Ensures timely submission of expedited reports to regulatory colleagues according to US FDA, EU and Canadian regulations. Working knowledge of validated drug safety databases (preferably ARGUS) and MedDRA.
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Experience in engaging regulatory professionals for navigating the product development process through FDA regulatory submission, scaling manufacturing, and post market surveillance. The successful candidate will be well-versed with the product development process and will work on a small team to develop and drive life-saving technology towards FDA approval.
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You will lead and direct strategy for regulatory compliance for all CSL Plasma Inc Operations to include:o Authorized Official contact e.g., with FDA and other health authorities. Accompany and negotiate with European and other foreign health authorities during Center and laboratory audits and consult with FDA inspectors.
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Expertise in Ligand Binding Assay Methods (ELISA, MSD, Gyrolabs, Simoa etc.) Exclusive preferred pricing on Peloton fitness equipment. Minimum of 5-10 years of hands-on experience in Bioanalytical Method Development, qualification, validation, and sample analysis to support GLP/nGLP studies.
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Provide consultations in the form of direct, one-on-one and small group education on regulatory aspects to the conduct of research throughout the life of the study, including: investigator and sponsor responsibilities, study conduct, adverse event reporting, documentation, consenting, protocol planning, IRB submissions, questions on study implementation, assistance with FDA IND/IDE submissions, consent development and writing, HIPAA issues, DSMP development, planning and submitting.
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Expertise in commercial healthcare and FDA regulatory law, specifically related to market access, pricing and price reporting, patient support, government contracting matters, and other laws and regulations related to the development and commercialization of pharmaceutical products.
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fda job in Boston, MA
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