- Merck & Co. (Rahway, NJ)
- …execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director may be responsible for:Evaluating pre- clinical and ... Principal Scientist) has primary responsibility for planning and directing clinical research activities involving new or marketed...Senior Director will manage the entire cycle of clinical development, including study design, initiation,… more
- Merck & Co. (Rahway, NJ)
- … Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed Neuroscience Medicines. ... business about twenty (20) percent of the time to manage future or ongoing clinical research projects. Education MD or MD/Ph.D. Required Qualifications Must have… more
- Merck & Co. (Rahway, NJ)
- … clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. Specifically, the Senior Director may ... commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; andAssist the Senior /Executive Director in… more
- Merck & Co. (Boston, MA)
- …execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May Be Responsible For: Evaluating pre- clinical and ... Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed...medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will… more
- Merck & Co. (North Wales, PA)
- …field or businessRequired Experience and Skills: Minimum of 5 years of experience in Regulatory Affairs or Clinical Research Excellent written and oral ... submissions requiring the inclusion of financial disclosure information, (3) coordinates regulatory submissions with our Research & Development Division's Global… more
- Merck & Co. (Upper Gwynedd, PA)
- …--The Senior Director will report to an Associate Vice President in the Oncology Clinical Research Group. Under the guidance of a supervisor, the Senior ... Director has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines. Our Oncology… more
- Merck & Co. (Rahway, NJ)
- …and key strategic engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability ... Job DescriptionOphthalmology Clinical Scientist:Job SummaryThis position leads the scientific planning and execution of one or more clinical trials or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …outstanding leadership skills based on a sound knowledge of clinical research standards and GCP.Develop operational strategies for ... research areas centered around rare diseases and immune disorders. SummaryThe Senior Director of Clinical Operations will manage clinical operations… more
- Merck & Co. (San Diego, CA)
- …initial content review and approval for IND/CSA submissions to enable clinical trial initiation.Participate in regulatory due diligence activities for ... sciences, chemistry, or related discipline with 10+ years of relevant drug development, clinical , or regulatory experience.M.D. or Ph.D./Pharm D with 7+ years of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a key member of the Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Under the Group's… more
- Merck & Co. (Rahway, NJ)
- … clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.- Specifically, the Senior Director may ... talented and dedicated colleagues while developing and expanding your career.The Senior Clinical Director (Sr. Principal Scientist) has primary responsibility… more
- Merck & Co. (Boston, MA)
- …about twenty (20) percent of the time to manage future or ongoing clinical research projects. Required Qualifications PhD degree in Immunology requiredMinimum of ... and models to drive program decisions.Detailed understanding of translational and clinical research methodology and biostatistics principles.Prior experience in… more
- Merck & Co. (Rahway, NJ)
- …in quality management or business management is preferred.Prerequisites:Minimum of 6 years in clinical research including at least 2 years with developing and ... readiness as well as preparing for, management and follow up of regulatory inspections.Operational Quality Management:The Clinical Quality Operations Manager is… more
- Merck & Co. (North Wales, PA)
- …, Regulatory , Statistical Programming, Data Management and other company Research Laboratories Scientists in designing and analyzing clinical trials, and ... Job DescriptionIn BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our...oral and written reports to effectively communicate results of clinical trials to the project team, management, regulatory… more
- Merck & Co. (Rahway, NJ)
- …the guidance of dCMC Regulatory A uthoring L eadership , t he Senior Specialist, Regulatory Authoring Data Analyst, will o ptimize regulatory authoring ... supply. - A key workstream within this initiative is the auto-generation of regulatory filing sections, enabled by a dedicated application designed to create a… more
- Merck & Co. (South San Francisco, CA)
- …Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs, and late-stage Clinical Research ... clinical study support staff and scientists (including discovery research , biostatistics, drug metabolism, modeling and simulation, regulatory affairs,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …development plans, clinical protocols, and in the submission of certain regulatory documents, as well as supporting commercial in developing a strategy including ... plans, clinical protocols, and in the submission of certain regulatory documents. Support commercial in developing a strategy including patient selection… more
- Formation Bio (New York, NY)
- …pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines ... progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately...to patients faster and more efficiently.About the PositionAs a Senior Data Engineer at Formation Bio, you will focus… 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. Summary: This is an ... oriented in the execution of processes, as directed by senior staff, playing a supportive role in ensuring adherence...and GCPs and is compliant with domestic and foreign regulatory requirement but may seek support on such items… more
- Insmed Incorporated (San Diego, CA)
- … regulatory strategies and risk assessments to cross-functional teams and senior leadership, as neededCollaborate with Clinical Development, Clinical ... day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've...therapy or orphan (rare) diseasesPrior experience serving as the regulatory lead on cross functional teams (CMC, clinical… more
