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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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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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4-5 years of clinical operations experience working for a direct pharmaceutical/biotech company (Sponsor side only). Independently manage interactions with clinical monitors, data management, safety, regulatory, pharmaceutical science, QA team members etc., both internally and externally including our CRO Partners, to ensure ongoing performance alignment.
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At least 3-5 years of relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity including at least 3 years of experience in Regulatory CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, or quality assurance/control or related technical field.
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Our client is a leading pharmaceutical company seeking a Director, Insights and Analytics for two different brands (2 different people). Minimum 10 +years relevant experience with a pharmaceutical or biotech manufacturer.
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Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. Minimum of 10 years of specialty pharmaceutical/oncology/rare disease sales experience with a minimum 2 years of successful field management experience.
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Analytical Skill, Analytical Skill, Analytical Thinking, Chemical Biology, Chemistry, Clinical Trials, Collaboration, Communication Skills, Curiosity, Data, Data Analysis, Design Of Experiments, Detail-Oriented, Drug Development, Drug Discovery, Ethics, Gene Therapy, Immunology, Inventory Management, Laboratory, Lifesciences, Machine Learning (Ml), Management, Medical Research, Molecular Biology {+ 10 more.
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The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders.
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Oversee the development and testing of clinical databases and data cleaning procedures, utilizing Medidata Rave/Veeva, and enforce data integrity through comprehensive documentation and quality control.
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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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We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification , a recognition of high social and environmental standards. We are a B Corp and Benefit company awarded Top Employer status for six consecutive years and certified as a Great Place to Work.
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MSD ELISA About PepGen PepGen Inc. is a clinical-stage biotechnology company advancing the next-generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases.
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PREFERRED: - 1 or more years of proven experience in a proteomics laboratory setting, preferably in a drug discovery biotech or pharmaceutical environment. This client is a company that’s leading the way in medical device industry.
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They are seeking a Regulatory CMC Director who can develop CMC regulatory strategies and prepare CMC submissions for their clinical-stage small molecule drug programs and approved product. Eight or more years in CMC Regulatory for small molecule pharmaceutical drugs.
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As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines.
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clinical pharmaceutical company jobs Company: Qps Holdings in Boston, MA
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