- Merck & Co. (Rahway, NJ)
- Job DescriptionAbout the Role:-As a Technical Lead, you will report into Director , Chemical Technical Operations, External Manufacturing API Technology, and ... play a pivotal role in managing the technical interface between our company and our External Partners...evaluating process change requests, and proactively managing process and technical risks. You will also oversee External Partners during… more
- Merck & Co. (Rahway, NJ)
- …the guidance of a senior leader, an Associate Principal Scientist/Associate Director , has primary responsibility for planning/managing real world and economic ... assessment (HTA) agencies, reimbursement decision makers, or national immunization technical advisory groups.Responsibilities and Primary ActivitiesParticipates in value evidence… more
- Merck & Co. (Rahway, NJ)
- …SummaryUnder the guidance of a senior leader, a Principal Scientist/ Director , has primary responsibility for developing value evidence strategies, and ... assessment (HTA) agencies, reimbursement decision makers and national immunization technical advisory groups.Responsibilities and Primary ActivitiesLeads value evidence teams… more
- Merck & Co. (Rahway, NJ)
- …Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director ).-This role serves as a Virtual Plant Manager - responsible for ... all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a strong business… more
- Merck & Co. (Rahway, NJ)
- …capability to solve unstructured problems, make informed risk decisions considering both technical & business risks, & influence portfolio decisions with facts and ... the principles of project management and clinical customer relationship management. - Technical Proficiency: familiarity with supply chain systems and software ( eg… more
- Merck & Co. (Rahway, NJ)
- …reaching patients around the world.Under the broad guidance of the Executive Director , GPAM, the core responsibility of this Value and Implementation Project Manager ... and expertise to other development teams and areas Sufficient-skill levels and technical comprehension of product development to be recognized as a project… more
- Merck & Co. (Rahway, NJ)
- …cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for ... providing strategic and technical leadership for analytical development of candidates from the discovery interface, through first product registration. They will be… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a strategic and technical leader with expertise in cell culture development & commercialization to lead a team of approximately 10-15 ... Commercialization (BDSC), Cell Culture Sciences department is to provide the technical leadership and laboratory capabilities in support of late-stage pipeline… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionThe Director of Medical Writing will be responsible for developing and implementing ... and scientifically accurate, and that messaging is consistent throughout all technical documentation to reflect the project and regulatory strategies and… more
- Formation Bio (New York, NY)
- …our CMC team. The ideal candidate will play a key role in providing technical leadership for the development, optimization, and validation of drug substance and drug ... collaboration with Quality and Regulatory colleagues.Responsibilities: Provide analytical development technical leadership for pre-clinical and clinical-stage large molecule therapeutics… more
- Eisai, Inc (Nutley, NJ)
- …and current regulations for those undertaking clinical studies.Job SummaryThe Associate Director , GCP Quality Assurance works within the Global Clinical Quality team ... related area. Minimum of 3-6 years of Clinical Quality Assurance auditing Technical and administrative capabilities to independently carry out routine, complex and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the vision and ... in RBQM. Accountable for selection and oversight of external vendors within technical scope. Will also be responsible for the internalization and oversight of… more
- Eisai, Inc (Nutley, NJ)
- …process.Experience with CRO oversight and FDA submission preferred.Excellent technical writing and verbal communication skills.Strong teamwork ability/commitment and ... individual initiative.Strong organizational skills with ability to effectively manage multiple studies.Excellent programming skills in SAS or R.Bachelor's degree (Master's preferred) and 10+ years of relevant experience.\nExperience in Life Sciences industry… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Compensation, Variable Pay. This role will serve as Global Technical Owner for the relevant area.ResponsibilitiesResponsible for the design, configuration, ... other external process steps where appropriate.Ensure and execute smooth operations and technical support of the relevant HRIS Module(s) including technical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: The Associate Director , Laboratory Data Management is accountable for the end-to-end delivery of ... strong working knowledge of laboratory data processes and industry standards, and technical skills in data received from CROs and vendors. This position requires… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CMO. This position develops strategy, prepares content templates and leads technical teams in preparation of submission documents to include clinical trial ... from preparation of the briefing book, to training and preparing the technical team, to authoring and finalizing the meeting minutes. This position develops… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other global functions as needed; proactively identify and resolve any technical , communication, and administrative issues. Help to improve and ensure consistency, ... queries. Actively participate/contribute to discussions in applicable working teams, technical teams, project teams, etc. Qualifications: Successful candidates will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Summary: The purpose of this job is to provide statistical programming technical support to DSI project teams on all statistical programming deliverables and ... to support outsourced programming activities and be responsible for the programming technical decision. By guiding other internal programmer or by self, perform… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Executive Director , Head of Center of Excellence (CoE), Global Medical Safety will ... and collaborate cross functionally.Must have in-depth understanding of the most recent technical and regulatory advancements Travel Ability Must be able to travel… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …validation studies in collaboration with Dx-partner Provides scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical ... Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory Liaisons to ensure successful implementation of CDx and data collection Supports Regulatory affairs in providing content and providing review of documents supporting CDx submissions to the… more
