Regulatory Documents Jobs in USA
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Associate Director, Process Chemistry (cmc)
Ardelyx
DescriptionArdelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States IBSRELA (tenapano...
Post Doctoral Fellow Radiation Oncology
University Of Kansas Medical Center
Department:SOM KC Radiation Oncology-----Radiation OncologyPosition Title:Post Doctoral Fellow - Radiation OncologyJob Family Group: Professional StaffJob Description Summary:This role provides advanced research training to support development of an independent research career. The fellow conducts r...
Director, Real World Evidence Virology
Gilead Sciences
At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight aga...
Manager, Regulatory Affairs
Generate Biomedicines
The Role:We are seeking a proactive and experienced Regulatory Affairs Manager to lead and coordinate global regulatory activities supporting the development of our biologic therapeutics. This role will independently manage key submission components contribute to regulatory strategy and help drive c...
In House Clinical Research Associate
Ardelyx
DescriptionArdelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States IBSRELA (tenapano...
Associate Director, Quantitative Clinical Pharmaco...
Sarepta Therapeutics
Why Sarepta Why Now The promise of genetic medicine has arrived and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle central nervous system and cardiac 2023 we launched our fourth thera...
Clinical Research Associateclinical Research Coord...
Mass General Brigham
Site: The General Hospital CorporationMass General Brigham relies on a wide range of professionals including doctors nurses business people tech experts researchers and systems analysts to advance our mission. As a not-for-profit we support patient care research teaching and community service strivi...
Senior Specialist, Regulatory Affairs
Hourglass Cosmetics
HOURGLASS COSMETICS Senior Specialist Regulatory Affairs (Hybrid Role)Connected by creativity and driven by purpose. Hourglass Cosmetics is a vegan and cruelty-free beauty brand redefining luxury cosmetics with high-performance products innovative formulas and award-winning franchises. Recognized b...
Clinical Research Coordinator I, Bilingual (spanis...
Seattle Children's Hospital
This position will work in a variety of settings including Seattle Childrens Hospital and Urgent Cares as well as local community pediatric clinics to work closely with children and families in the community. The successful candidate will be comfortable explaining our research studies to potential p...
Post Doctoral Fellow Pediatrics (center For Health...
University Of Kansas Medical Center
Department:SOM KC Pediatrics (PEDS)-----Behavioral PediatricsPosition Title:Post Doctoral Fellow - Pediatrics (Center for Healthy Lifestyles and Nutrition)Job Family Group: Professional StaffJob Description Summary:The Postdoctoral Fellow in the Center for Healthy Lifestyles and Nutrition (CHLN) par...
Staff Clinical Evaluation Specialist (remote)
Stryker
Work Flexibility: RemoteWe are seeking a Staff Clinical Evaluation Specialist to join our Instruments division. In this role you will collaborate closely with cross-functional teams including Regulatory Clinical Research Quality and Marketing to ensure the successful preparation of high-quality subm...
Director Of Regulatory Affairs
Scripps Research
ABOUT USCalibr-Skaggs Institute for Innovative Medicines a division of Scripps Research is a first-of-its-kind nonprofit translational research institute dedicated to creating the next generation of medicines. Calibr-Skaggs was founded on the principle that the creation of new medicines can be accel...
Clinical Development Associate Medical Director- P...
Vertex Pharmaceuticals
Job DescriptionGeneral Summary:The Clinical Development Associate Medical Director will serve as the Medical Lead for clinical trials working with cross-functional teams on trial strategy design execution and addition to oversight and accountability for the study as a whole this role will serve as...
Regulatory Affairs Coordinator I
Mass General Brigham
Site: The Brigham and Womens Hospital Inc.Mass General Brigham relies on a wide range of professionals including doctors nurses business people tech experts researchers and systems analysts to advance our mission. As a not-for-profit we support patient care research teaching and community service st...
Pharmacology Research Scientist
Vertex Pharmaceuticals
Job DescriptionThe Pharmacology group at Vertex Pharmaceuticals in San Diego is seeking a highly motivated and innovative Pharmacology Research Scientist to join our team. The successful candidate will focus on developing and applying primary tissue assays for drug discovery with a particular emphas...
Senior Manager, Core Labeling Strategy
Mylan
Mylan Inc.Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life we...
Precision Medicine Global Biomarker Lead (gbl)
Amgen
Career CategoryClinicalJob DescriptionJoin Amgens Mission of Serving PatientsAt Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.Since 1980 weve helped pioneer the world of biotech in our...
Head Of Neuromuscular Diseases, Translational Medi...
Novartis
Job Description Summary#LI-Hybrid Internal job title: Executive Director Location: San Diego California USAAs the Head of Neuromuscular Diseases within Translational Medicine you will serve as a senior scientific and strategic leader responsible for shaping and delivering the translational strategy...
Clinical Research Monitor
Mass General Brigham
Site: Mass General Brigham IncorporatedMass General Brigham relies on a wide range of professionals including doctors nurses business people tech experts researchers and systems analysts to advance our mission. As a not-for-profit we support patient care research teaching and community service striv...
Sr. Principal, Clinical Development Project Lead –...
Alcon Research
At Alcon we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly champion progress and act with speed as the global leader in eye care. Here youll be recognized for your commitment and contributions and see your career like never before. Together we go above and...