- Merck & Co. (Rahway, NJ)
- …Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed Neuroscience Medicines. ... clinical study reports, or publication;Participation in internal and joint internal/external research project teams relevant to the development of new… more
- Merck & Co. (Rahway, NJ)
- …(Senior Principal Scientist) has primary responsibility for planning and directing clinical research activities involving new or marketed cardiovascular and ... clinical study reports, or publicationParticipating in internal and joint internal/external research project teams relevant to the development of new… more
- Merck & Co. (Rahway, NJ)
- …Principal Scientist) has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines. Our ... study reports, or publication; andParticipation in internal and joint internal/external research project teams relevant to the development of new compounds,… more
- Merck & Co. (Boston, MA)
- …(Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed medicines in the ... clinical study reports, or publicationParticipation in internal and joint internal/external research project teams relevant to the development of new… 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. (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...of structured content management .- They will also support project management activities to ensure efficient execution and compliance… 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 medicines… more
- Insmed Incorporated (San Diego, CA)
- …experience serving as the regulatory lead on cross functional teams (CMC, clinical and project teams)Ability and experience in the development and execution ... 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… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …outstanding leadership skills based on a sound knowledge of clinical research standards and GCP.Develop operational strategies for ... within Clinical OperationsDevelop risk assessment & risk management and clinical project management competencies within Clinical OperationsWork in… 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 ... writing, and presentation skillsEducation/ExperienceBachelor's Degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as 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. (North Wales, PA)
- … Clinical Documentation, Clinical Investigations, Clinical Judgment, Clinical Reporting, Clinical Research , Clinical Trial Documentation, ... input into research and business development priorities and prioritization of clinical assets.-May serves as the senior liaison for relevant stakeholders in the… more
- Merck & Co. (North Wales, PA)
- …datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing ... of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.-The position 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...communicate results of clinical trials to the project team, management, regulatory agencies, or individual… more
- Merck & Co. (North Wales, PA)
- …Algorithms, Applied Mathematics, Biostatistics, Business Process Improvements, Business Strategies, Clinical Development, Clinical Research , Clinical ... datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing… more
- Merck & Co. (San Diego, CA)
- …and key strategic engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)-Ability ... PowerPoint, Word, Outlook, etc.)Education/ExperienceBachelor's Degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical… 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
- Merck & Co. (North Wales, PA)
- …datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing ... and maintain statistical databases that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.Act as a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Reporting ... Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high impact projects, fostering s culture of… more
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