- Merck & Co. (North Wales, PA)
- …programs and medical education programsMinimum 18 months of experience in US and ex-US Regulatory , Compliance and Risk Management aspects and ability to lead ... the legitimate business need for each program. In collaboration with business and strategy teams, the Sr. Specialist develops an annual plan of programs that… more
- 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
- 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
- Merck & Co. (Washington, DC)
- Job DescriptionPosition Description: Associate Director, Policy Strategy and Capabilities The Associate Director, Policy Strategy and Capabilities is ... Engagement team, reporting to the Executive Director, Policy Development & Strategy .The Associate Director will develop and maintain the strategic planning digital… 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. (North Wales, PA)
- …and how the various functional areas contribute to a comprehensive strategy .Project management certification (PMP) and/or formal coursework/training in project ... Job Description Position Description: Senior Specialist, Project Management - Drug Development The Senior Specialist, Project Manager is a core member of Early Drug… 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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network Manages Phase 1-3 ... eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse events)- May participate in Site Initiation Visit… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …market dynamics. It will also include commercial ownership of portfolio level device strategy and lifecycle management of devices. Relationships Reports to the ... (MAPA), to co-create strategies for a cohesive portfolio planning, device strategy and indication management . Facilitate communication and coordination across… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in how we engage customers. Leverage analytics and market research to inform strategy and opportunities for growth Business Operations Management : Develop and ... thinking and analytical skills, with the ability to translate insights into strategy Excellent communication and stakeholder management skills, with ability to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with cross-functional teams to refine product positioning, pricing strategies, and lifecycle management tactics Lifecycle Management Strategy : Lead the ... and risk assessments to inform decision-making and prioritize initiatives Risk Management : Proactively identify and mitigate risks associated with product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Oncology Clinical Development, an organization dedicated to the effective strategy , design, execution, and interpretation of Oncology clinical trials. Serves ... medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network, Manages Phase 1 -… 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)
- …reviews.Develop and maintain a central repository for knowledge and life-cycle management of the program to support regulatory filings.Required Experience ... Quality, Upstream/Downstream Process Development, Formulations, Global Clinical Supply, CMC Regulatory , Quality, and Commercial-facing Partner Groups to support commercialization… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory / Risk Management , Quality Assurance, Medical Affairs, ... Translational Research, Research, Informatics Services, Project Management and Operational Management . Develop a strong, positive strategic business partnership… 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
