- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Overview:-We are seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in ... with numerous stakeholders such as , Clinical Research Associates, Statisticians, Quality Assurance, and Regulatory Affairs to drive data excellence and enhance… more
- Merck & Co. (Rahway, NJ)
- …therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management . The team is externally visible and continues to be at the ... drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be an experienced pharmacometrician with a strong,… more
- Merck & Co. (Rahway, NJ)
- …Technical Operations,-Single Use Technology, or Sterile Operations.Strong project and time management skills to facilitate on-time delivery and quality ... Job DescriptionPosition Description:Reporting to a Technology Director or Associate Director in Global...the implementation of the business solution using the Capital Management stage gate process with varying degrees of responsibility… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of… more
- Merck & Co. (Rahway, NJ)
- …network to enable process and formulation development.- In this position the SMAR&D Director will set guidance, lead activities, and develop a team whose roles ... and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing...innovative ways to achieve results.Nature and Scope of Position:The Director reports to the Executive Director of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a detail-oriented Associate Director of Consolidation Accounting, tasked with the role of overseeing the accurate and timely ... enhancing their business acumen for future opportunities.Reporting directly to the Director of Consolidation Accounting, this role is integral to our financial… more
- Merck & Co. (Rahway, NJ)
- …Lab Lead will be expected to exhibit a mindset of safety and quality compliance, which will include following current Good Manufacturing Practices (cGMPs), and ... internal resources and academic or industrial partnerships.- In partnership with the Director of Chemical Engineering R&D, the Crystallization Lab Lead also plays a… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs the Director /Principal Scientist in Devices and Drug-Device Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the ... Director of Device Regulatory Affairs for Autoinjector Development Programs....accuracy and completeness of submissionsPartner with Device Development, Device Quality , and other Drug stakeholders to communicate and align… more
- Merck & Co. (Rahway, NJ)
- …accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director Data Science will be responsible for developing and communicating data-driven and actionable insights that drive greater ... strategiesBe accountable for ensuring delivery of analyses with high quality standards, timeliness, compliance, and excellent user experience (routinely keep… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Merck & Co. (Rahway, NJ)
- …multiple sites, managing regulatory audits, internal quality and safety audits, quality notices, CAPA management as the business area representative, as well ... track internal compliance metrics and report the observed trends to senior management .Provide regulatory support by preparing or reviewing high- quality CMC… more
- Merck & Co. (Rahway, NJ)
- …& connectivity between functions supporting pipeline (ie clinical development, Compound Management Coordination , supply chain, & human health), and balancing needs ... Clinical Supply Planning program representative) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines,- strategies… more
- Merck & Co. (Rahway, NJ)
- …on scientific education and dialogueBusiness and market knowledge, including quality management .Excellent interpersonal, communication, and networking skillsMust ... collaboration to further differentiate our portfolio.The Oncology Regional Medical Scientific Director , RMSD, is a credentialed (ie, MD, PhD, or PharmD) therapeutic… more
- Merck & Co. (Rahway, NJ)
- …efficient, effective, and compliant business standards, process maps, and risk management for global processes across Global Regulatory Affairs and Clinical Safety ... Safety , including training process standards and strategies to ensure optimal quality and compliance in Global Regulatory Affairs and Clinical Safety business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary Leads the development and management of DSI's local and global Strategic PV Partnerships and contracts including ... and proactively drive operational excellence and continuous improvement. Oversees the management of Global PV Regulatory Intelligence (PVRI) and dissemination across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and proficient in creation of process maps preferredExperience working with Quality Management systems preferredExperience with requirements related to global ... Director , Development SOP Management Join a...Authorship and Review Maintain a close working relationship with Quality Assurance and participate in the Company Global SOP… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ensuring the quality of PM activities including: communication, planning and management of schedule, budget, scope, issue risk management , and quality ... and Corporate Functions. They are responsible for ensuring consistent and effective management of approved Global and Regional IT projects and optimized PM resource… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for ... of trial, clinical trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input on ICF creation;… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global Clinical Study ... study and post-marketing protocols and the Clinical Study Oversight Plan, day-to-day management of DS Safety Notification Letter (SNL) System and oversee TMF… more
