- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …duties include:Overseeing vendors and internal personnel to ensure the successful design , development and roll-out of training programs, projects, or key ... meetings.Assist in the evaluating, selecting and managing department vendor and procurement processes.Systems administration including the integration of FMA business needs with technological systems to facilitate activity/workload reporting, knowledge… more
- Merck & Co. (North Wales, PA)
- …documents/amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection in alignment with the protocol in ... collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and integrity of trial conduct.Providing tactical/scientific mentorship to other clinical scientists.Core Skills: Solid… more
- Merck & Co. (Durham, NC)
- …qualification through licensure and ramp up.- - Participate in document design activities working alongside operations team members to develop reliable, consistent ... manufacturing processes that meet cGMP requirements. - Promote a culture of visibility and accuracy of the project schedule and update dashboards accordingly to highlight project status to critical milestones . - Working in conjunction with all appropriate… more
- Insmed Incorporated (San Diego, CA)
- …Director of PM will work with the PM team and global organization to design new processes and supporting business structures and recommend new and global solutions ... that drive process standardization and simplification across the company. We are open to discussions about location flexibility or remote work arrangements; however, co-location with the San Diego Office is preferred.ResponsibilitiesPartners with functional… more
- Merck & Co. (Rahway, NJ)
- …ranging from individual clinical trials to world-wide regulatory application submissions. Design and maintain statistical datasets that support multiple stakeholder ... groups.Collaborate with statistics and other project stakeholders in ensuring project plans are executed efficiently with timely and high-quality deliverables.Serve as statistical programming point of contact and knowledge holder through the entire product… more
- Merck & Co. (Durham, NC)
- …and analyze relevant data and prepare appropriate reports for regulatory submissions.- Design validation studies, author and approve protocols, and ensure alignment ... with corporate standards and site guidance for validation.Serve as mentor for less experienced teammates, assisting with technical development.Author or update Validation SOPsAssist with troubleshooting and effectively resolving problems. Develop and implement… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …department level- Study Outputs: Has strong understanding of statistics and study design principles applicable to primary and efficacy and safety endpoints in ... registrational trials to critically assess study conclusions and new study designs for early stage.- External collaboration: Ensure continuous, effective alignment within / between CRO and vendors; For large, multiple indication project in late development,… more
- Merck & Co. (Rahway, NJ)
- …/ process improvement initiatives across PMO user personas (analysis, design , build, implementation prep, implementation, hyper care).Lead for change management ... for PMO enhancements impacting Development Project Management user persona and any other owned user personas. Qualifications, Education, Experience, and Skill Requirements Required Qualifications Bachelors degree required.Minimum of 4 years of experience in… more
- Merck & Co. (North Wales, PA)
- …of brand strategy for our HIV products through close collaboration with the Design Team, Customer Agile Team, Sales Leadership, Learning & Development, and Brand ... Communications. This talented individual will lead ongoing field sales integration and maximization of customer engagement capabilities (Field Suggestions, Field Email, Next Best Engagement, etc.). Additionally, this role will work to understand customer… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Contributes along with CSL and/or Medical Monitor to development of study design to meet study objectives, development of biomarker/PK strategy in collaboration with ... Translational Medicine and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV… more
