- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant ... medical topics, and supports PV Operations ' medical review function. This position supports a senior...board eligibility preferred Experience Qualifications1 or More Years of clinical experience preferred Daiichi Sankyo, Inc. is an equal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders.Provides support ... other research areas centered around rare diseases and immune disorders. Summary The Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execution plans across and effective alignment within (eg with translational research, clinical operations , clinical development, medical affairs CSPV and ... A cross-Oncology Development Medical Doctor position reporting to the Head Clinical Development Functional Excellence. This position complements CSPV and GMA efforts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Director , Global Oncology Medical Affairs, Evidence Generation role is responsible for ... using trackers and tools generated by Global Oncology Medical Affairs Study Operations partners and propose mitigation plans for delayed activities. Ensure that… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.SummaryThe Senior Director , Global Oncology Medical Affairs, Evidence Generation role is responsible ... using trackers and tools generated by Global Oncology Medical Affairs Study Operations partners and propose mitigation plans for delayed activities. Ensure that… more
- Merck & Co. (Rahway, NJ)
- …(Non-Sterile) team at the FLEx Center in Rahway is looking for an Associate Director - Process Engineer to lead clinical supply manufacturing, scientific rigor ... is a multi-modality (small molecule, biologics, vaccine) Drug Product development and clinical manufacturing facility in Rahway, New Jersey.- This team works with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the US, EU, Japan, and other global sites. These business functions include: Clinical Operations , Clinical Development, Biostatistics and Data Management, ... Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the US, EU, Japan, and other global sites. These business functions include: Clinical Operations , Clinical Development, Biostatistics and Data Management, ... Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Clinical Director (Principal Scientist) has primary responsibility for planning and directing clinical research activities involving ... in Immunology. With a focus on late-stage development, the Clinical Director will manage the entire cycle...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with other functional areas such as biostatistics, data management, clinical operations , pharmacovigilance, regulatory affairs, etc. Qualifications: Successful ... of analysis data sets and tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads ... mentors and may manage assigned staff, partnering with the Global Labeling Operations & Compliance group and across the cross-functional and cross- regional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data ... and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes… more
- Merck & Co. (Rahway, NJ)
- …integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory, Operations , Non- clinical , Clinical , and other functional ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder minimal guidance of the Executive Director / Director /Associate Director , Pharmacovigilance (PV) Partner Strategy & Management (PV-PSM), ... partner and vendor PV agreements and leadership of the Global Clinical Safety & Pharmacovigilance (GCS&PV) implementation activities for partner deals including… more
- Merck & Co. (Rahway, NJ)
- … Director in Medical Writing will be responsible for overseeing clinical trial data registration, results postings, redaction operations , external data ... and compliance with global disclosure requirements. Primary Responsibilities:Responsible for clinical trial data registration, results postings, redaction operations… more
- Merck & Co. (Rahway, NJ)
- …across both diagnostics and pharma? Then you could be our new Global Marketing Director of Digital Diagnostics! - The Position: We are currently recruiting for a ... Marketing Director , Digital Pathology within our Precision Medicine, Global Oncology...closely partnering with external digital pathology collaborators Gathering unmet clinical needs, market requirements, scoping and planning product concepts,… more
- Merck & Co. (Rahway, NJ)
- …and increased integration of Chemistry Manufacturing & Controls (CMC) and Clinical strategies.- Position Description/Summary: The Associate Director , Project ... Chemistry Manufacturing & Controls (CMC) development plans.Under the guidance of the Director & Portfolio Lead, the core responsibility of this individual will be… more
- Merck & Co. (Rahway, NJ)
- …Our Company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the entire cycle of ... placement, monitoring, analysis, regulatory reporting, and publication. Specifically, the Director may be responsible for:-Evaluating pre- clinical and… more
