📑 Primary Skills:GCP big queryPython programmingStrong SQL Teradata to GCP migrationRequired Skills:· Strong experience in Spark, need to be able to tune the spark jobs.· Strong Python programmer.<br ...
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📑 Lead the regulatory efforts for IND-enabling activities, including the preparation of the Investigational New Drug (IND) application for our groundbreaking oncology and CNS therapies targeted for submission this year and early next.Be the go for all things regulatory and acting as a key voice to the future of all trials, SOPs and s ...
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📑 Regulatory Affairs Specialist II (Clinical)Bridgewater, NJ-100% Remote7 Months contractPay Rate: $45-55/hr on w2Candidates can be located in any US time zone, they must be able to work EST hours from 9AM-5PM EST Possibility of Extension Role will work independently and ...
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📑 Overview /Benefits Weekend availability preferred, Guard License and Driving License Here at Brosnan Risk Consultants , our culture encourages and supports diversity throughout the workplace! We offer both full-time and part-time opportunities. We also pride ourselves on promoting within. Many ...
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📑 Title: Manager/Senior Manager US Regulatory Affairs - Global Development Projects Location: Remote Type: Contract Rate: 52-70 (DOE) Start Date: ASAP Leading Pharmaceutical Company located in NJ is hiring a Manager/Senior Manager US Regulatory Affairs - Global Development Projects with 5+ years industry ex ...
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📑 Responsibilities: US Agent for all products, responsible for communication between the FDA and manufacturing sites. Communicate and follow-up status with FDA for any Chemistry, Bioequivalence and Patents issues and correspondences on both pending and approved applications. Lead ...
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📑 Requisition Number2229806 Description & Requirements Location: Location: This position can be filled in any of our FORVIS office locations or can be a fully remote work opportunity. Ready to Accelerate Your Career? Join our rapidly expanding advisory team! Our Advisory practice brings our f ...
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📑 Software Guidance & Assistance, Inc., (SGA), is searching for a Regulatory Affairs Senior Manager for a FULL TIME assignment with one of our premier Pharmaceutical Services clients in Hawthorne, NY.Responsibilities: ...
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📑 Responsibilities: Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision. Responsible for the global regulatory evaluation of CMC ch ...
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📑 BS/BA degree in Scientific Discipline with3 years in the pharmaceutical industry, preferably with 1 year CMC regulatory experienceResponsibilities will include, but are not limited to, the following:1. Participate in the development of the CMC regulatory strategy for biologics submissions. ...
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📑 Responsibilities will include, but are not limited to, the following:1. Participate in the development of the CMC regulatory strategy for small molecules. These submissions include health authority briefing packages, IND/CTA, NDA and MAA regulatory filings.2. Prepare and review CMC submission documents, regi ...
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📑 Our client is a Construction firm specializing in healthcare and life sciences interior construction supporting clients in the Tri-State area. The firm is continuing to grow and are looking to add to a team that already consists of about 15-20 employees. They are seeking a Estimator with previous experience in healthcare or life sciences construc ...
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📑 Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions. These submissions include health authority briefing packages, IND/CTA, BLA/NDA and MAA regulatory filings. Prepare and review CMC submission documents, regist ...
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📑 Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules. These submissions include health authority briefing packages, IND/CTA, NDA, and MAA regulatory filings. Prepare and review CMC submission documents, registration dossiers, health authority briefing ...
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📑 PREREQUISITES BS/BA degree in Scientific Discipline (Masters or higher preferred) with5-7 years in the pharmaceutical industry, preferably with 1-3 years CMC regulatory experience. Experience with sterile products preferred.Location can be Lawrenceville or Summit West.Responsibilities wil ...
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📑 Role SummaryReporting to the Executive Director of Analytical Development and Quality, the Director of Quality Control provides leadership of a scientific team that will execute the development and management of analytical assays related to AAV-based gene therapy programs. This role will also manage the QC testing ...
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📑 Company Background:Stealth, VC-backed, discovery-stage biotech company with significant funding focused on discovery and development of breakthrough biologics in Oncology and Immunology. This small but experienced team is currently expanding headcount to support the next phase of growth through IND submissions and ...
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📑 • Global management of preclinical pharmacology and translational pharmacology • Responsible for pre-clinical pharmacology and translational pharmacology research for drug discovery and development for immune oncology, immune / autoimmune disease and metabolic disease therapeutic areas to advance drug candidates from preclinical discovery ...
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📑 We are seeking a preclinical/translational pharmacologist with experience in developing oncology small-molecule therapeutics. The ideal candidate would have solid experience in designing and conducting preclinical/translational pharmacology studies and be knowledgeable in molecular pathways involved in cell death and survival and experienced in ...
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📑 Company Overview: Eliksa Therapeutics is an entrepreneurial, venture-backed biotech company specializing in developing treatments for rare diseases. Our lead product candidate, ELK-003, is a biological drug aimed at treating the ocular manifestations of epidermolysis bullosa. Our pilot clinical trial in Chile is scheduled to begin in May 2024. Role ...
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📑 Vous souhaitez gagner en liberté, vous rémunérer à votre juste valeur en faisait un métier passionnant, et tout ça depuis chez vous ? Devenez Agent Indépendant en Immobilier megAgence !Indépendant, mais jamais seul, l'humain est au cœur de notre activité et de nos valeurs. Chez meg ...
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📑 What this position is all about: We are looking for a strategic and results-driven Head of Regulatory Affairs (level commensurate with experience) to lead our regulatory efforts and activities for the advancement of our assets through early clinical development. This individual will play a pivotal role in shaping the regulatory ...
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📑 About UsSerna Bio is building the world's first map of the druggable transcriptome, systematically opening up the universe of RNA biology to small-molecule drug modulation. Using our Discovery Platform, we are tackling the classically intractable targets, with an initial focus on Oncology and Rare Disease.The curren ...
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📑 Our Client is a Metal Surface Coating and Treatment company bases with a shop in New Britain, CT. They started in 1929, with the mission to keep different metal products longer lasting and resistant to fatigue, corrosion, and heat damage. They support mostly OEM parts in the aerospace, defense, power generation, oil and gas, and ground transportati ...
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📑 The CompanyDelix Therapeutics is a neuroscience company focused on harnessing the power of psychoplastogens—novel neuroplasticity-promoting therapeutics—to treat brain health disorders. Delix is advancing these compounds through preclinical and clinical development to bring patients FDA-approved medicines that will addres ...
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📑 About us:Our client is a leading multi-practice law firm serving the public and private sector with offices throughout Connecticut and the Northeast. They are looking for a legal assistant to support 3 attorneys while the current assistant is on leave. These practices areas include medical malpractice, tax appeals and employment ...
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📑 TASKS(1) Participate in the review, planning and implementation of clinical trials for the treatment and/or prevention of Tuberculosis (TB), HIV/AIDS, co-infections, and/or related co-morbidities. This includes evaluating the hypothesis, objectives, study design, feasibility, and regulatory requirements, as well as identi ...
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📑 Lab Assistant Mission Bay Campus The Institute for Neurodegenerative Diseases (IND) is a world-class research facility focused on understanding and developing therapies for neurodegenerative diseases. The Kampmann lab in the IND develops and uses innovative technologies to understand cellular and molecular mechanisms o ...
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📑 Overview: HarmonyCares is one of the nation’s largest home-based primary care practices. HarmonyCares is a family of companies all dedicated to providing high-quality, coordinated health care in the home. This includes HarmonyCares, HarmonyCares Medical Group, HarmonyCares Home Health and HarmonyCares Hospice.<p style=m ...
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📑 Personnel Resources has a client immediately hiring for a Janitor at a local manufacturer in Geneva, AL.Pay will start at $12.50 per hour and will work a Monday - Friday daytime schedule. Duties:Maintain the cleanliness of the facility inside and outTake out trashSweep and mop floorsCl ...
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📑 Overview: HarmonyCares is one of the nation’s largest home-based primary care practices. HarmonyCares is a family of companies all dedicated to providing high-quality, coordinated health care in the home. This includes HarmonyCares, HarmonyCares Medical Group, HarmonyCares Home Health and HarmonyCares Hospice.<p style=m ...
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📑 Company Background:Stealth, VC-backed, discovery-stage biotech company with significant funding focused on discovery and development of breakthrough biologics in Oncology and Immunology. This small but experienced team is currently expanding headcount to support the next phase of growth through IND submissions and ...
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📑 About LexeoLexeo Therapeutics is a New York City-based, clinical-stage genetic medicine company dedicated to transforming healthcare by applying pioneering science to fundamentally change how genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease are treated. Using a stepwise dev ...
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📑 Pay Range: $33.85-$52.52 Company Overview: The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life. Our specialized care teams provide personalized, compassionate, expert care to patients of a ...
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📑 Pay Range: $33.85-$52.52 Company Overview: The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life. Our specialized care teams provide personalized, compassionate, expert care to patients of a ...
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📑 Pay Range: $33.85-$52.52 Company Overview: The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life. Our specialized care teams provide personalized, compassionate, expert care to patients of a ...
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📑 Pay Range: $33.85-$52.52 Company Overview: The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life. Our specialized care teams provide personalized, compassionate, expert care to patients of a ...
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📑 Pay Range: $33.85-$52.52 Company Overview: The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life. Our specialized care teams provide personalized, compassionate, expert care to patients of a ...
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📑 About Evrys Bio: This is an opportunity to join a small, entrepreneurial, and well-funded private biotech company. Building on research breakthroughs from an internationally renowned scientific team, our research platform has enabled us to discover new antiviral drugs, with a different mechanistic approach, that will change the way infection is tre ...
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📑 Our Company:Evestra, Inc. is an emerging biopharmaceutical company that focuses on developing and commercializing women’s healthcare products. Based in San Antonio, Texas, Evestra’s mission is to improve the health and well-being of women around the world through innovative technologies and products. </stro ...
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📑 Senior Director / Vice President, Regulatory Affairs - Obesity and Associated Metabolic DiseasesLocation: Charlotteville, VA or Bay Area, CA Rivus Pharmaceuticals is searching for a Senior Director / Vice President, Regulatory Affairs to set and lead the regulatory strategy ...
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📑 Director, CMC Regulatory AffairsDirect Hire Fulltime RoleSalary Range: $208,000 - $235,000 per yearLocation: Redwood City, CA - Hybrid RoleJob Summary:The position is responsible for providing CMC regulatory strategies and lead ...
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📑 Director, CMC Regulatory AffairsDirect Hire Fulltime RoleSalary Range: $208,000 - $235,000 per yearLocation: Redwood City, CA - Hybrid RoleJob Summary:The position is responsible for providing CMC regulatory strategies and lead ...
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📑 SummaryThis position reports to the Functional Area Head, Global Regulatory Affairs. The incumbent responsible for supporting the development and implementation of regulatory strategies, work closely with the cross functional asset teams to prepare, review and submit regulatory filing documents, manage documentation syste ...
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📑 Compensation: $20.75/hour + .67 cent per mile travel reimbursement from first to last stop on route Schedule: Full-time. Friday - Tuesday work sche ...
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📑 Century Group is partnering with a client who is seeking a Portfolio Reporting Analyst to join their team. Exact compensation may vary based on skills, experience, and location. Expected starting base salary $65, to $68, per year. Job Responsibilities : Produce monthly client statements or upon request Re ...
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📑 Minimum 10 years of experience in the biopharmaceutical industry and 5 years of direct experience in a regulatory strategy role requiredExperience supporting clinical development teams in the autoimmune disease space is a mustProvides regulatory guidance and input to project teamsDesigns and implements regulatory ...
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📑 Description: Diagnose and repair corporate vehicles. Work with Engineering to identify and root cause quality issues. Perform vehicle maintenance, where applicable. Support Engineering with special studies/projects. Supporting groups such as, Fast Feed Back, Safety Office, Parts Return Center, Lapeer Road Marshaling Center, Executive garage, Execut ...
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📑 Responsibilities: Provides strategic global regulatory guidance to cross-functional project teams responsible for product development. Actively leads the development and implementation of regulatory strategies for assigned programs and ensures cross-functional alignment. <br ...
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📑 *This position is onsite in Ridgefield, CT & remote*Currently seeking a Global Case Management Associate (GCM) to join our Patient Safety & Pharmacovigilance (PSPV) team located at our Ridgefield, CT facility. The GCM will provide case processing and auditing support.Duties & Responsibilities:< ...
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