- Daiichi Sankyo, Inc. (Bernards, 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder minimal guidance of the Executive Director / Director / Associate Director , Pharmacovigilance (PV) Partner Strategy & Management ... of PV agreements, PV plans, and SMPs.Maintains, in collaboration with the Executive Director / Director / Associate Director PV-PSM, the internal guidelines… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary: The Associate Director of Regulatory Writing is a key role responsible for ... producing scientifically accurate, high- quality clinical regulatory documents while adhering to...and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess… more
- Merck & Co. (Rahway, NJ)
- …job that provides a high degree of technical and project management responsibility. The Associate Director - Process/Facility Lead position will report to the ... Responsibilities include the following:The process/facility lead role at the Associate Director level will serve as a...compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of ... Global Medical Affairs' externally sponsored clinical research (ESR) initiatives, ensuring strict adherence to Good Clinical Practices (GCPs), relevant Standard… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the franchise Leads the development of the payer value story, supported by credible clinical , health economics and quality of life messages in order to justify ... responsible therapeutic / franchise area(s). Relationships Reports to Senior Director , Value Communication and Contracting Strategy. Interacts frequently in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality ... Daiichi Sankyo (DS) in the US, EU, Japan, and other global sites. These business functions include: Clinical Operations, Clinical Development, Biostatistics and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D ... Global Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources , and stability, uniting the best of both worlds to… 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 ... Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes Processes and Best Practices: Reinforces labeling best… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... of statistical activities; collaborates closely with data manager to ensure high quality data.Drug Development Strategy: Provides input to multiple aspects of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium complexity ... activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical programmer.Drug Development Strategy:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …robust publication plans for the Therapeutic Area and respective products. Mentor Associate Director Publication leads on publication planning and execution ... research areas centered around rare diseases and immune disorders. Summary Director , Global Medical Affairs Oncology Publications works with Cross Functional Team… more
- Merck & Co. (Rahway, NJ)
- …approach, driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will ... solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory, Operations, Non- clinical , Clinical , and other… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Science, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Non- clinical , Medical Affairs, Marketing, Legal, Quality , and other ... and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct… more
- Daiichi Sankyo, Inc. (Bernards, 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
- Eisai, Inc (Nutley, NJ)
- …and make a difference. If this is your profile, we want to hear from you. Director , Global RWE & Data Science sought by a pharmaceutical company in Nutley, NJ. Assess ... programs in support of global market access initiatives. Lead clinical meaningfulness initiatives that address issues such as payer...that address issues such as payer challenges, impairments in quality of life and patient well-being, and gaps in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for operational improvements and seek agreement through consensus management.RelationshipsReports to an Associate Director / Director within the NNI ... and Strategic Sourcing activities. This position will ensure the acquisition of high- quality goods/services at the best possible prices by negotiating and monitoring… more
- Baylor Scott & White Health (College Station, TX)
- …Within this framework, accountable for monitoring and accessing Sleep Lab quality , policies and procedures, staff and equipment performance. Communicates and ... ESSENTIAL FUNCTIONS OF THE ROLE Performs polysomnographic studies in a clinical setting, including oxygen and nasal continuous positive airway pressure titrations.… more
- Takeda Pharmaceuticals (Boston, MA)
- …is true to the best of my knowledge. **Job Description** **Job Title** : Associate Director , Clinical Quality Compliance **Location** : Cambridge, ... MA **About the role:** As the Associate Director , Clinical Quality Compliance, you will provide quality oversight to the clinical trial delivery … more
- Humana (Tallahassee, FL)
- …a part of our caring community and help us put health first** The Associate Director , Stars Improvement, Clinical is responsible for the development, ... implementation, and management oversight of the company's Medicare/Medicaid Stars Program. The Associate Director , Stars Improvement, Clinical requires a… more
