- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Executive Director, Global Clinical Operations Study Management Group Head has ... of study management and delivery for all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for ensuring the … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, ... Affairs, as well as cross-functional stakeholders (eg, RA CMC, R&D Excellence, Clinical Operations , IT).Responsibilities Operate within and in support of the… more
- Daiichi Sankyo, Inc. (Munich, ND)
- …global oncology early development studies, functional lines including, global regulatory operations , biostatics, data management, clinical science and ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...assessing potential new FIH sites and in FIH site clinical operations methods required.Experience in site selection… more
- Merck & Co. (Rahway, NJ)
- …existing and pipeline products to produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director, is ... Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and… more
- Merck & Co. (Rahway, NJ)
- … Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and ... and insurance process management. Enters and updates country information in clinical and finance systems.Ownership of local regulatory and financial… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …solutions. Support product launch activities by partnering closely with Supply Chain Technical Operations teams and Global Regulatory Leads to release high ... opportunity employer including veterans and people with disabilities.SummaryThis position leads the Global Regulatory Affairs (GRA) Global Labeling function,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategic outsourcing and performance indicators In collaboration with other Vice Presidents of Clinical Operations in other global locations and therapy ... this is a key new role to lead the Clinical Operations function across our Boston, MA...other areas of Global Development and US Clinical , Medical and Regulatory (CMR). Your skills,… more
- Merck & Co. (North Wales, PA)
- …Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external ... Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their assigned projects in the Vaccines and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...record keeping and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to… more
- Merck & Co. (Rahway, NJ)
- …formulations, and devices. The Executive Director, as a senior member of the Global Regulatory Affairs and Clinical Safety: Chemistry, Manufacturing and ... GRACS CMC Leadership Team. Their role is pivotal in fostering alignment and global execution across Regulatory Affairs, R&D, Manufacturing, and our Commercial… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a key member of the General Medicine Global Clinical Development team, the Vice President/ Therapeutic Area (TA) Head's primary objectives will ... Development Teams (PDTs) and collaborating with Section Heads, PDT Leaders, and Clinical Directors responsible for the design and medical monitoring of clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …North America Clinical Development (NACD) Clinical Medical & Regulatory (CMR), Future Business Strategy (FBS), Strategic Operations (SO, Human Resources. ... About the Department The Clinical , Medical and Regulatory (CMR) department...resources within NACD. Relationships Reports to Snr Director of Clinical Strategy and Business Operations within Operational… more
- Novo Nordisk Inc. (Atlanta, GA)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- … development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be responsible ... Job DescriptionOur company is a global health care leader with a diversified portfolio...closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical… more
- Merck & Co. (Rahway, NJ)
- …to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Clinical Director ... closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Merck & Co. (North Wales, PA)
- …corporate standards and policies and business objectives.Actively- participate in labeling and global regulatory team meetings to ensure support for anticipated ... and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- …clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be ... Job DescriptionOur company is a global health care leader with a diversified portfolio...closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical… more
- Merck & Co. (North Wales, PA)
- …studies.-Under the direction of the Program Lead, you will collaborate with global , cross- functional team-members including clinical directors and study ... clinical trial team.Collaborates with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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… more
