- Merck & Co. (North Wales, PA)
- …submissions requiring the inclusion of financial disclosure information, (3) coordinates regulatory submissions with our Research & Development Division's Global ... and Skills: Minimum of 5 years of experience in Regulatory Affairs or Clinical Research Excellent written and oral communication skills required Proficient with… more
- Merck & Co. (Rahway, NJ)
- …Drug Development, Ethical Standards, Intellectual Curiosity, Management Process, Medical Research , Regulatory Affairs Compliance, Regulatory Reporting, ... has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines. Our company's oncology… more
- Merck & Co. (Rahway, NJ)
- …key strategic engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple ... attendance is required for, field-based positions; facility-based, manufacturing-based, or research -based positions where the work to be performed is located… more
- Merck & Co. (San Diego, CA)
- …key strategic engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)-Ability to manage multiple ... attendance is required for, field-based positions; facility-based, manufacturing-based, or research -based positions where the work to be performed is located… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …stakeholders within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs.Facilitate operational meetings with ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Manage… more
- Merck & Co. (Rahway, NJ)
- …Curiosity, Interdisciplinary Problem Solving, Neuropathic Pain, Neuroscience, Neuroscience Research , Pain Management, Pharmaceutical Development, Regulatory ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing… more
- Merck & Co. (Rahway, NJ)
- …Mentorship, Pharmaceutical Development, Pulmonary Arterial Hypertension, Pulmonary Disease Research , Pulmonary Disease Treatment, Pulmonary Disorders, Pulmonology, ... Scientist) has primary responsibility for planning and directing clinical research activities involving new or marketed cardiovascular and respiratory medicines.… more
- Merck & Co. (Rahway, NJ)
- …supply. - A key workstream within this initiative is the auto-generation of regulatory filing sections, enabled by a dedicated application designed to create a ... frictionless flow of data from source systems to regulatory documentation .-- - Under the guidance of dCMC...teams to gather business requirements, and coordinate with IT, Research , and Manufacturing to capture feedback on developed capabilities… more
- Merck & Co. (San Diego, CA)
- Job DescriptionThe Global Regulatory Liaison is responsible for developing and implementing worldwide regulatory strategies for assigned projects within the ... of contact, with significant experience, the Liaison provides strategic regulatory oversight to accelerate approvals and optimize product labeling.This position… more
- Insmed Incorporated (San Diego, CA)
- …team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 ... Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director, Regulatory Affairs will serve as the regulatory leader on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders Job Summary: The Head ... of Regulatory Advertising and Promotion (RAAP) will lead and oversee all regulatory activities related to the review, approval, and compliance of advertising and… more
- Merck & Co. (Boston, MA)
- …Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed medicines in the Atherosclerosis section ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May Be… more
- Merck & Co. (North Wales, PA)
- …of an Executive Director, within the Value and Implementation, Outcomes Research the incumbent has the following responsibilities:1.) development of the integrated ... vaccines on a worldwide basis and 3.) development and implementation of Outcomes Research (OR) and Real World evidence programs to meet the value evidence needs… more
- Merck & Co. (South San Francisco, CA)
- …and external clinical study support staff and scientists (including discovery research , biostatistics, drug metabolism, modeling and simulation, regulatory ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs, and late-stage Clinical Research throughout… more
- Merck & Co. (Rahway, NJ)
- …as well as preparing for, management and follow up of regulatory inspections.Operational Quality Management:The Clinical Quality Operations Manager is accountable ... clarity and business effectiveness.- This will include ongoing partnership with our research division QA and acting as the link between Clinical Development, study… more
- Merck & Co. (Upper Gwynedd, PA)
- …Medical Research , Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance, Regulatory Compliance {+ 5 more}-Preferred Skills:Job ... quest for cures and is committed to being the world's premier, most research -intensive biopharmaceutical company. Today, we're doubling down on this goal. Our R&D… more
- Merck & Co. (North Wales, PA)
- … Regulatory , Statistical Programming, Data Management and other company Research Laboratories Scientists in designing and analyzing clinical trials, and in ... Job DescriptionIn BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development… more
- Merck & Co. (Rahway, NJ)
- …device engineering, particularly in the design, manufacturing, and regulatory aspects of Autoinjectors and combination products.Primary Responsibilities:Technical ... and manufacturing of Autoinjectors, ensuring compliance with industry standards and regulatory requirements (eg, ISO 13485, FDA regulations). Actively seek out,… more
- Merck & Co. (Boston, MA)
- …for leading the diagnostics strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development. The successful candidate will have an ... stakeholders to ensure alignment with clinical development timelines and regulatory requirements. Most importantly, the role requires overseeing CDx development,… more
- Merck & Co. (Rahway, NJ)
- …and supply.A key workstream within this initiative is the auto-generation of regulatory filing sections, enabled by a dedicated application designed to create a ... frictionless flow of data from source systems to regulatory documentation.- Under the guidance of dCMC Leadership, the Senior Specialist, Digital CMC Data Analyst,… more
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