- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director, Policy Development and Strategy is a key leadership role in the Global Public Policy Strategic Planning & External Engagement ... geo-political trends, and proactively directing policy development activities to mitigate risk and leverage opportunities in support of our company's business… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Early Device Program Strategy and Due Diligence The Principal Scientist of Early Device Program Monitoring & Due Diligence will ... will adeptly handle the following key responsibilities:Team Leadership and Interface Management :Manage a small team of engineers to serve as interfaces between… more
- Merck & Co. (Rahway, NJ)
- …and training materials. Identifies industry best practices and leads knowledge management regarding important regulatory developments.Leads/co-leads and acts as ... emerging signals, trends and risks and provides feedback to management as appropriate.Directs and oversees the overall strategy... as directed by the CQOL- Inspection & Enterprise Management , related to regulatory agency inspections.Act as… more
- Merck & Co. (Rahway, NJ)
- …and tools.Proactively resolve project obstacles and challenges and communicate device development strategy , design controls and risk management approaches ... manufacturing process development, qualification and validation, design controls and device risk management techniques to positively support and influence… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... and mentor talentStrategic and critical thinking to advance biopharmaceutics strategy across the portfolioProject management skillsAttention to technical… more
- Merck & Co. (Rahway, NJ)
- …to develop a breadth of experience including finance, accounting, analytics, risk management , and special project opportunities.MCAAS Innovation FLDP ... ; this includes a deeper knowledge of internal controls, business compliance, and risk management . Individuals will be based in the global headquarters in… more
- Merck & Co. (Rahway, NJ)
- …database expertise. Familiarity with statistical analysis methods and clinical data management concepts.US and/or worldwide drug or vaccine regulatory ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (Rahway, NJ)
- …oral, sterile and combination products. You will also contribute towards regulatory submissions to enable clinical trials. Your main responsibilities will ... lifecycle, as well as responding to agency questions.-Scientific Excellence and Regulatory Influence:Promoting our company's scientific excellence and regulatory … more
- Merck & Co. (Rahway, NJ)
- …of Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and ... role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as...strong network internally and across the external academic and regulatory community is expected, as well as advancing a… more
- Merck & Co. (Rahway, NJ)
- …to develop a breadth of experience including finance, accounting, analytics, risk management , and special project opportunities.Corporate Audit and Assurance ... ; this includes a deeper knowledge of internal controls, business compliance, and risk management . Individuals will be based in the global headquarters in… more
- Merck & Co. (Rahway, NJ)
- …the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for ... understanding of statistical terminology and conceptsFamiliarity with clinical data management conceptsExperience in CDISC and ADaM standardsExperience ensuring process… more
- Merck & Co. (Rahway, NJ)
- …(AVP)/Section Head, Global Clinical Development, Respiratory will focus on driving strategy , development, and life-cycle management activities in the ... functions and processes relevant to drug development, and project management principles as applicable to the pharmaceutical industry.Primary Responsibilities:Leads… more
- Merck & Co. (Rahway, NJ)
- …this program to develop a breadth of experience including finance, accounting, analytics, risk management , and special project opportunities. - - After 24- 36 ... as product knowledge, healthcare systems, payors and customers , regulatory , business operations and reputational risks while working...into business practices and the execution of the company's strategy . Individuals will be based in the global… more
- Merck & Co. (Rahway, NJ)
- …scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in solving complex analytical problems ... technical personnel, leading projects, and defining group or departmental strategy will aid in distinguishing candidates.--An established reputation for scientific… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe ESG Strategy & Engagement team is part of our company's Social Business Innovation (SBI) department within Corporate Affairs. The ESG team works ... metrics; and collecting, editing and summarizing contentLead workstreams related to EU regulatory requirements for ESG-related disclosures, as well as those for our… more
- Merck & Co. (Rahway, NJ)
- …and SAP Development.- They will also have responsibility for the end-to-end Upgrade strategy from roadmap to execution for the entire SAP Ecosystem (private cloud ... professional development opportunities to team members.SAP Basis DEV/OPSOversee the management and maintenance of the SAP technical infrastructure.Ensure system… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to update organizational charts, team lists and track projectsProvide Strategy Operations support for regulatory inspection related activities ... to support the implementation of the Global R&D PV QA organizational strategy . This position will proactively collaborate with other Global quality colleagues to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulatory documents where necessary with supervision. This position conducts regulatory risk assessment and recommends developmental options with ... years pharmaceutical industry experience and 4+ years direct or related CMC regulatory experienceSuccessful track record in preparation, management of review and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requirements, and industry best practices.Ensure /support the development of GLP/GCLP systems, risk management processes such as SOPs for QA activities for ... Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …On-Prem, Service Provider Outsourcing). Contribute to the Daiichi Sankyo validation strategy by considering regulatory requirements, industry best practices and ... Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global… more
