- Sanofi Group (Cambridge, MA)
- …not limited to FDA, OIG, DDMAC/OPDP,PhRMA,ICMJE,ISPOR). + Oversee conduct of all clinical studies in adherence to both Company standards , and government/industry ... to applicable SOP(s). + Partner with US Drug Safety in the management of clinical trial adverse events, post-marketing safety data , and in the communication of… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Participates in strategic and operating planning activities in partnership with the Global Clinical Leads, in translating corporate and divisional initiatives ... and clinical trial design (protocol and CRF development), execution ( data collection, analysis, and interpretation), and closeout (final reporting). + Develops,… more
- Bristol Myers Squibb (Princeton, NJ)
- …with deep expertise in assay and IVD development-including analytical validation, clinical development, manufacturing, and global regulatory submissions through ... apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of… more
- Medtronic (Orlando, FL)
- …physicians, hospital support staff and Medtronic personnel. Stay abreast of and communicate clinical data regarding Medtronic products and TAVR therapy + Sales ... quality assurance within Medtronic + Help drive and maintain quality initiatives and global best practice initiatives + Maintain high standards of personal… more
- Bristol Myers Squibb (Madison, NJ)
- …and establish priorities + Strong understanding of healthcare industry regulatory compliant data standards . **Why You Should Apply** Around the world, we ... to inform evidence generation, supporting developing clinical program design, clinical trial execution, and other data -driven decision-making activities. The… more
- Merck (Rahway, NJ)
- …CDISC SDTM and ADaM standards + Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH + Designs ... drugs and vaccines for the benefit of patients and global human health. This position provides high quality statistical...Specific Required Skills and Experience:** + Programming expertise with clinical endpoint data (efficacy and safety) and… more
- Boehringer Ingelheim (Ridgefield, CT)
- …strong understanding of the therapeutic area, the US healthcare landscape, the relevant clinical practice guidelines, and the emerging scientific data as well as ... and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering… more
- Gilead Sciences, Inc. (Washington, DC)
- …to come. The Real-World Evidence (RWE) function at Gilead is part of the Clinical Data Sciences (CDS) group within the Clinical Development organization ... of accountability for the development, execution, and communication of the global RWE strategy supporting early-stage clinical development and post-authorization… more
- J&J Family of Companies (Irvine, CA)
- …industry trends, understand clinical /medical insights, unmet medical needs and global standards of care to deliver quality products/solutions. **What you ... You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial...will have medical affairs responsibility in providing therapeutic and clinical expertise in support of the development of cardiac… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …as well as Health Economics and Market Access (HEMA) to run biostatistics and data management in support of clinical evidence generation strategies across the ... clinical studies and RWE research using multiple clinical trial data and healthcare administrative ...different evidence generation programs. + Ensure compliance with regulatory standards relevant to medical devices (eg, FDA, EMA, PMDA),… more