- National Institutes of Health (Montgomery County, MD)
- …Employment Qualifications Education Qualification Requirement: In order to qualify for a Lead Regulatory Operations Specialist-GS-0601-14, position you must ... Requirement: In addition, in order to qualify for a Lead Regulatory Operations Specialist, GS-0601-14,...applications; providing guidance on regulations, policies, and procedures governing clinical trials operations and regulatory … more
- Astellas Pharma (Northbrook, IL)
- ** Clinical Operations Lead ** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to ... mitigation (as appropriate). + Ensure close collaboration between Early and Late-Stage Clinical Operations Lead (s), including providing strategic and… more
- AbbVie (Jersey City, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description AbbVie Clinical Data Strategy & Operations is the best-in-class team within ... acts as single point of contact and accountable operational lead from DSS. + Coordinates associated DSS study teams...in oversight of vendors and provides feedback related to clinical trial operations , issues, and trends in… more
- AbbVie (Florham Park, NJ)
- …audits + Participates in oversight of vendors and provides feedback related to clinical trial operations , issues, and trends in performance + Responsible for ... bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and… more
- Organon & Co. (Raleigh, NC)
- …work collaboratively with cross-functional colleagues in preclinical science, data science, clinical operations , regulatory affairs, chemistry, manufacturing ... management for TMED studies, in collaboration with the TMED operations lead , bioanalytical or modeling leads, procurement and clinical business operations… more
- Dana-Farber Cancer Institute (Boston, MA)
- The Assistant Regulatory Operations Manager (AROM) is a newly created position and will be responsible for aiding in oversight of the Leukemia disease group's ... training, and daily supervision support. The AROM takes the lead as directed for the collaboration / navigation with... submissions reaching the activation phase to ensure both Clinical and Regulatory Operation teams are on… more
- System One (Florham Park, NJ)
- …(renewable) Senior Regulatory Operations Associate Contractor The Senior Regulatory Operations Associate Contractor will lead in the preparation ... + Effectively communicate and work collaboratively with cross-functional teams, including regulatory affairs, clinical operations , and quality assurance… more
- Astellas Pharma (Northbrook, IL)
- … commitment trials (interventional and non-interventional). + This position is accountable to the Clinical Operations Lead and will lead the ... objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements + Manage and lead cross-functional...and provide regular updates of trial progression to the Clinical Operations Lead and other… more
- Astellas Pharma (Westborough, MA)
- …and global stakeholders. **Essential Job Responsibilities:** + Acts as a CMC regulatory lead and/or Deputy for highly complex projects/products and/or ... and Scope:** This position plays a key global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturing and Controls (CMC) aspects of … more
- Pfizer (Pearl River, NY)
- …interfaces with discovery, safety sciences, statistics, clinical pharmacology, commercial, regulatory , outcomes research, Clinical Operations , and other ... **Role Summary** The Global Clinical Lead functions independently and has...key opinion leaders, and principal investigators:** + Participate in Clinical Regulatory Authority interactions responsible for providing… more
- Takeda Pharmaceuticals (Boston, MA)
- …is true to the best of my knowledge. **Job Description** The Head of Regulatory Operations at Takeda will be responsible for formulating and implementing the ... Operations (GRA-Ops) vision and strategy to achieve a best-in-class Regulatory Operations organization. The role will involve envisioning and implementing… more
- Pfizer (Groton, CT)
- …and study management, knowledge of Good Clinical Practices (GCPs), monitoring, clinical , and regulatory operations required + Demonstrated experience in ... impact on society.** **What You Will Achieve** As a Clinical Study Team Lead (CSTL), you will...plans. In this role, your strong leadership skills and clinical operations expertise will help make Pfizer… more
- Bristol Myers Squibb (Princeton, NJ)
- …CSs. Should work to proactively partner with these roles + Accountable for clinical content for CSRs, regulatory reports, briefing books, submission documents, ... Summary** + CDLs are matrix leaders and managers who lead , develop, motivate and achieve results through teams; demonstrate...analysis and reporting of studies. + Serves as Primary Clinical Representative in Regulatory interactions + Evaluates… more
- Pfizer (San Diego County, CA)
- … clinical trial biomarker assays. + Coordinate with Study Teams and clinical operations to ensure appropriate biomarker sample handling and processing steps ... expertise to Study Teams to ensure delivery of high-quality clinical biomarker data. + Lead novel assay...+ Maintain up-to-date knowledge of biomarker assay technologies and clinical laboratory standards, regulatory guidance (eg, GLP,… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …As a senior member of Clinical Operations , the Senior Director, Clinical Operations will lead the full development team in designing, planning, ... milestones for the company, drawing on expertise in clinical and regulatory requirements, both local and...processes and requirements, and effectively applies this knowledge to lead the clinical operations department… more
- Takeda Pharmaceuticals (Boston, MA)
- …inspire you and empower you to shine? Join us as a BST and Clinical Biomarker Lead , Neuroscience, Associate Director in our Cambridge, MA location. _Objective ... small molecules, antibodies, nucleic acids and more). + BST Lead will support the clinical development of...leadership informed of progress + Collaborates cross functionally with Clinical Sciences, QCP, Regulatory , DMPK, Research and… more
- Abbott (Philadelphia, PA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** The **Associate Clinical Site Lead ** for the Philadelphia, PA region drives ... failure, attrition rate, etc. Monitors to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards inclusive… more
- CareFirst (Baltimore, MD)
- …members and communities. Leads the development of clinical and diagnostic clinical operations strategy. The Vice President will lead and build a team of ... programs lines of business. + In depth knowledge of clinical operations and regulatory compliance...to make process streamlining recommendations. + Demonstrated ability to lead and motivate staff; and affect change.Must be able… more
- Bristol Myers Squibb (Princeton, NJ)
- …Requirements:** + Advanced knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations + Ability to plan and manage + Advanced ... in their personal lives. Read more: careers.bms.com/working-with-us . The Clinical Science Lead reports through the ...contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (eg, IB,… more