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At least 10 years relevant clinical drug safety/pharmacovigilance experience within the pharmaceutical or biotech industry, including 3+ years vendor oversight experience, required. Company Overview Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.
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The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases.
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QualificationsRequired Skills 4+ years Clinical Database programming experience working in the biotechnology or pharmaceutical industry; experience working with CROs highly desirableTechnical/Software Skills: Expertise with Medidata RAVE (Custom Function programming) required.
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HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. The Sr. Scientist of Upstream Process Development will oversee the development of all upstream technical activities (including microbial strain generation, fermentation/upstream process development) through the clinical development of recombinant norovirus vaccine program.
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Founded by an internationally recognized team of neurodegenerative biologists from Harvard Medical School and Harvard University, QurAlis is a clinical-stage biotechnology company advancing a pipeline with therapeutic candidates that target specific components of ALS and FTD pathology and defined patient populations based on both disease-causing genetic mutation(s) and clinical biomarkers.
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We are a market leader in automated bio sample management solutions and genomic services across areas such as drug development, clinical and advanced cell therapies for the industry's top pharmaceutical, biotech, academic and healthcare institutions globally.
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Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases.
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Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. Minimum 12 years' experience as a safety physician with the biotechnology / pharmaceutical industry, leading drug safety & pharmacovigilance, including cross-functional team leadership for signal detection, evaluation, risk classification and management, and communication, for products across multiple stages of development.
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Along with the CLIA Lab Director and leadership, maintain laboratory audit readiness by overseeing and managing clinical lab audits with regulators, pharmaceutical partners, and with other agencies, ensuring that internal system and process audits are scheduled and conducted.
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CQV Engineer - Downstream - Life Sciences - Contract - Massachusetts Our client, a leading partner to pharmaceutical, biotech and nutrition markets, has an exciting opening for a CQV Engineer – Downstream for their new Capex investment project.
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Demonstrated knowledge in the following scientific fields: organic chemistry, synthetic chemistry, medicinal chemistry, and pharmaceutical sciences. Demonstrated knowledge in the following scientific fields: organic chemistry, synthetic chemistry, medicinal chemistry, and pharmaceutical sciences.
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Collaborates with the Dana-Farber Harvard Cancer Center DFHCC quality assurance of clinical trials office in developing protocol specific materials. Overview The Research Nurse in collaboration with the physician, is responsible for the implementation and evaluation of clinical research in their specific program/area.
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Responsible for ensuring development programs are operating in compliance with the EU/FDA regulatory requirements and in compliance with company standards. Thorough knowledge of FDA and EU cGMPs and pharmaceutical manufacturing and analytical requirements.
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Knowledge of the Pharmaceutical Industry Clinical study process (clinical study conduct, documentation and reporting) in accordance with ICH/GCP and other regulatory compliance guidelines.
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The Implementation Consultant - Veeva CRM will be responsible for supporting implementation and upgrade projects around Veeva CRM (and related technologies) for RCM's Life Sciences (Pharmaceutical, Biotech, Healthcare Medical Device) clients.
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clinical pharmaceutical company jobs Company: Qps Holdings in Waltham, MA
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