- Novo Nordisk Inc. (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Associate Director , Medical Affairs Omnichannel Engagement, role is to support the ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and governing the medical affairs omnichannel engagement strategy. The Associate Director - MOE will work with one… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of research and strategic partnership contracting agreements. In collaboration with the Associate Director , the Associate Manager will support CMR's ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and external stakeholders Relationships This position reports to an Associate Director overseeing the contract management function… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for ... - Leadership, Direction, and Strategy:Leads implementation of Therapeutic level clinical data collection requirements including cross-functional standards initiatives by… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …stud(ies).Ensures trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to optimize medical coding processes, technology, and standards. This position ensures quality delivery of medical coding for clinical trials, clinical ... Develops and proposes strategies for medical coding and coding dictionary ensuring all clinical trials meets quality requirements and best practices in medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.SummaryThe Associate Director (AD) is responsible for overseeing all activities ... corporate communications and select medical material) is of the highest scientific quality and is compliant with all relevant policies, procedures, and regulations,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data ... Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes Processes and Best Practices: Reinforces labeling best… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …position is accountable for partnering with the Global Team and Global Clinical leader to ensure effective team operations through meeting management, development ... of these objectives. This position will report to the Sr. Director , Group Leader, GPM&L. Responsibilities Project Responsibilities: Independently manage and drive… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position Manage and oversee all assigned projects/products/processes. Assist the Director / Associate Director in assuring Novo Nordisk compliance ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...regulatory agencies. Supervise designated personnel. Relationships Report to the Director / Associate Director /Lead Regulatory Scientist/Sr. Manager… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global Head ... CSPV and key business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(from business understanding, over hands-on development to dissemination), to ensure high quality deliverables are on time and within budget. The position holder ... and best practices as well as strong technical skills in working with ( clinical ) data. The position holder will require strong skills in continuous improvement,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …manage, with limited direction, Biostatistics study activities assigned and ensure high quality deliverables are on time and within budget. The position may also ... collaborate with CROs ( Clinical Research Organizations) and manage oversight. The position will partner with internal and external stakeholders to optimize… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …submission requirement, review study submission data package and ensure its quality and integrity.- Provide hands-on statistical programming support to regulatory ... to support submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables on time and within budget to support drug development ... and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to seek alignment and share resources across multiple groups. Relationships Reports to Associate Director or above within CMR Training & Knowledge Management. ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Manager role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This ... primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical...share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis and ensure… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewAssociate Director , Tech Ops (Process Chemistry) will have responsibility for the ... operations at Insmed's CMOs including tech transfer, process optimization, clinical /commercial manufacturing, process characterization and validation, and manufacturing CMC… more
- Insmed Incorporated (Bridgewater, NJ)
- …for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role focuses on LC-MS/MS of small and large ... bioanalytical methods and sample analyses of regulated bioanalytical assays for clinical , nonclinical and biomarkers studies. This translational role resides within… more
