- BioAgilytix (Durham, NC)
- The Regulatory Affairs Manager is responsible for coordinating the regulatory activities for projects including new products and life cycle management. ... / clinical trial applications per the requirements of key regulatory agenciesCoordinates regulatory issue resolution using internal resources, regulatory… more
- Merck & Co. (North Wales, PA)
- …Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to ... or clinical experience, preference if this experience is in regulatory affairs .Required Experience and Skills: Regulatory experience preferred for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …need to partner closely with teams and senior leaders from across Regulatory Affairs , as well as cross-functional stakeholders (eg, RA CMC, R&D Excellence, ... centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key... will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …management of financial budgets and resource strategies for a VP Function of the Clinical Development, Medical & Regulatory Affairs (CMR) Business Unit. The ... difference? The Position The CMR Business Planning & Strategy Manager will be responsible for facilitating the creation and...and resource strategies within a VP Functional area of Clinical Development, Medical & Regulatory Affairs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …work regularly with all business areas (Sales, Marketing, Clinical , TMPC, Med Affairs , and Regulatory Affairs ) and support functions (IT, Finance, HR, ... and Legal).ResponsibilitiesTraining CommunicationsPlan, create, develop/build, draft and deliver various, innovative training vehicles to inform and educate employees on compliance issues through the utilization of existing and novel technological solutions… more
- Tris Pharma (Monmouth Junction, NJ)
- …initiatives. This includes, but is not limited to: Research, Product Development, Clinical Development, Regulatory Affairs , CMC, New Products, Sales ... in our Monmouth Junction, NJ facility for a Senior Manager , Business Development.The primary role of the Senior ...provide input on deal terms and creation of relevant clinical , regulatory , and commercial scenarios Prepare clear… more
- Arthrex (Naples, FL)
- …documents and coordinates with additional collaborators including product management, statistician, regulatory affairs , clinical research management, and ... Experience as a clinical research professional and knowledge of clinical regulatory regulations is required. Excellent communication and analytical skills,… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …and shift the way providers think about value-based care. Shall promote all clinical programs available as a resource to facilitate full engagement and improve ... internal and external risk adjustment training curriculum and programsShall set priorities for RA staff in a manner that executes on the right set of initiatives… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Close collaboration with Product Management, Risk Management, R&D and Regulatory Affairs to provide input on deliverables, clinical research and literature ... purpose and our core values by staying **True to Life.** **Job Description** The Clinical Evaluation Manager reports directly to the Regional Lead, Clinical … more
- Reynolds American (Winston Salem, NC)
- …Clinical Studies **Number of Direct Reports** 0 **Core Relationships** **Internal** - Clinical Studies, Scientific & Regulatory Affairs , Product ... Sr Scientist Clinical Data Manager Reynolds American is...Proficiency and ability to apply and document quality and regulatory practices / procedures supporting research studies. + Ability… more
- BeiGene (Emeryville, CA)
- …in assigned region in close collaboration with regional study start up team and regulatory affairs + Ensures regional and country information in study systems ... progress in the region to senior management and Global Clinical Study Manager as required + Represents...region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders + Provides regional input… more
- Actalent (Cambridge, MA)
- …Programmers, Medical Monitors and Clinical Operation Trial Lead, Pharmacovigilance, Regulatory Affairs , and other line functions/departments on clinical ... setting * At least 8+ years as a lead Clinical Data Manager * Proficient in ...and standards (CDASH, SDTM) * Knowledge and understanding of regulatory requirements and expectations for clinical data… more
- Johns Hopkins University (Baltimore, MD)
- …+ Requires minimum of two years of management experience. + Requires experience in clinical research and regulatory affairs . + Experience in protocol and ... the division. The Sr. Clinical Research Program Manager will be responsible for ensuring regulatory ...and/or clinical trials. + Requires experience in clinical research and regulatory affairs … more
- Dignity Health (Phoenix, AZ)
- …!** **This position will be responsible for steering the regulatory affairs of a groundbreaking multi-center clinical study in translational ALS research. ... Clinical Research Regulatory Project Manager...high attention to detail and subject matter expertise in Clinical Research Regulatory Affairs management… more
- Abbott (Pleasanton, CA)
- … clinical trial design, by collaborating closely with the statistician, medical affairs , and regulatory affairs personnel, that appropriately satisfy the ... schedules while enhancing productivity and product quality. **THE OPPORTUNITY** **Senior Manager , Clinical Science** We have an exciting opportunity for… more
- University of Miami (Miami, FL)
- …the efforts of relevant team members to manage, retain and control all applicable Regulatory Affairs submissions pertaining to University held INDs and IDEs as ... . The Department of Pathology and Laboratory Medicine is currently seeking a full time Manager , Clinical Research to work in Miami, FL. The Manager , … more
- Olympus Corporation of the Americas (Center Valley, PA)
- … Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/ RA ) ... purpose and our core values by staying **True to Life.** **Job Description** The Clinical Quality Assurance Manager reports directly to the Executive Director of… more
- Hackensack Meridian Health (Hackensack, NJ)
- …executed. + Works on special projects for Research department quality assurance, regulatory affairs and education sections, including review and submission of ... and serve as a leader of positive change. The Manager , Clinical Research Ops is responsible for... Clinical Research Ops is responsible for the Clinical Coordinators, Clinical Data Coordinators, Regulatory… more
- Dignity Health (Phoenix, AZ)
- …with organizational goals.. * Collaborate with internal cross-functional teams, including clinical operations, data management, regulatory affairs , and ... therapies for brain tumor patients. Job Description: The Ivy Clinical Research Project Manager is responsible and accountable for providing the coordination and… more
- Abbott (Santa Clara, CA)
- …and exchange of documents between stakeholders (eg, internal personnel such as Regulatory Affairs , R&D Engineering, Clinical Engineering, A&P and ... MN currently has an opportunity for an on-site **Senior** ** Clinical Scientist/Project Manager Clinical Evaluation**...5-7+ years of experience in clinical research, clinical affairs , regulatory affairs… more
