- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Associate Director, Global Medical Affairs (GMA) Oncology- Medical Content and Training ... is responsible for execution of global scientific and training deliverables. The Associate Director develops and executes Medical Content and Training plans and… more
- Merck & Co. (North Wales, PA)
- …aCRF; knowledge of Analysis Dataset Model (ADaM) and Analysis Data Reviewer 's Guide (ADRG) considered a plus.Excellent communication and interpersonal skills and ... ability to negotiate and partner effectively.Excellent written, oral, and presentation skills.Excels in technical writing, able to convert complex ideas and information into simple readable form.Strong project management skills; Manage at a program level;… more
- Merck & Co. (Durham, NC)
- …developing and expanding your career. - Position Description:- We are seeking an Associate Director within the Durham Operations team. The Associate Director in ... objectives - Functional Expertise:- Specific to their area, the Associate Director will be responsible for comprehensive management of...is trained on new or revised processes or procedures Review and approve Quality Notifications (QNs) - Author, … more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Associate Director, Quality Technical, is responsible for leading a team that supports deviation management, change control, site ... activities with department objectivesFUNCTIONAL EXPERTISE:Specific to Technical Support, the Associate Director will be responsible for comprehensive management of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: The Associate Director of Regulatory Writing is a key role responsible for producing ... provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director of Regulatory Writing is a key role responsible for producing ... provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Summary: The Associate Director, Regional Marketing Conventions & Field Programs will be ... while ensuring adherence to DS policies and procedures. The Associate Director, Regional Marketing Conventions & Field Programs is...areas.Meet with Sales Leadership on a regular basis to review processes and gain insight of the field needs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director, Program Management is a senior position responsible for effectively ... risks as well as achieving overall project level quality metrics. An ideal Associate Director, Program Management must have the expertise and leadership to manage… more
- Merck & Co. (Washington, DC)
- …to inform annual GPP Strategy development, external engagement planning, and quarterly review and reporting. The Associate Director will conduct routine and ... Job DescriptionPosition Description: Associate Director, Policy Strategy and Capabilities The ... Associate Director, Policy Strategy and Capabilities The Associate Director, Policy Strategy and Capabilities is responsibility for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders.Summary This position is responsible for contract creation and review including: (A) overseeing the day-to-day operation of contract management ... clients (varying levels) and external vendors. Works with company attorneys to review legal language for company agreements. As necessary, negotiates with opposing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …QA relevant activities including QQR, monthly quality report, team building and management review .- Involve and attend the Global QA relevant meeting and create the ... a sufficient access to the system and information to do that work.- Review the QA onboarding business slides edits and updates as needed Qualifications: Successful… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study problems. Responsibilities Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, ... for complex studies including study design, protocol development, CRF review , SAP development, analysis files development, statistical analysis accuracy validation,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CCDS; Ensures implementation of CCDS/labeling agreements with licensing partners.Conduct Label Review Committee Meetings: Prepares documents for review by ... for US, EU and Company Core documents as well as for the review of country labeling deviations.Ensure Compliance with Labeling Regulations and Guidance: Researches… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC ... on Harmonization (ICH), and other applicable regulations. This includes preparation, review , and approval of CMC documentation for BLA Supplements (PAS, CBE-0,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Associate Director of ERP Applications is responsible for overseeing and enhancing ... for reviewing unit test plans to ensure all requirements have been met. Review integration test plans and perform integration testing as necessary to ensure that… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical ... clear direction and guidance to project teams.Committee Facilitation: Facilitate review committee meetings, ensuring comprehensive documentation of meeting outcomes,… more
- Merck & Co. (Rahway, NJ)
- …the right amount of product at the right place, at the right time.The Associate Director, Animal Health Global Supply Chain Regional Operations will be the single ... planning process, supporting the 5 Year Plan and Assumptions Based Review process, and providing support to implementation of Supply Chain Strategies.Primary… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …written assessments of relevant medical topics, and supports PV Operations' medical review function. This position supports a senior physician in evaluating and ... event level AE causality assessment. This position requires manager review and gains industry knowledge through multiple opportunities. ResponsibilitiesSafety Expert… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with us? The Position The purpose of the Peer to Peer Tech & Innovation Associate is to assist in the management and optimization of the Peer-to-Peer HCP engagement ... the accuracy and timeliness of HCP engagement records. The associate will support efforts to adapt and optimize systems,...costs, and outsourced FTE. Support budget coordination and tracking, review and audit all final bills, and assist in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to the process of application for charitable grants and corporate giving Must review , assess and revises relevant procedures as to their efficiency, workflow and ... personnel in the group on grants portal as needed Oversees the processing, review (CSSI, Legal and Compliance) and payment of all charitable giving requests… more
