- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Leads US FDA/EU EMA interactions with support from higher-level manager. Regulatory Knowledge: Demonstrates expert knowledge of US /EU regulatory ... contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC...as the company liaison with the Health Authority (eg, US FDA and EU EMA) for assigned projects with… more
- Eisai, Inc (Nutley, NJ)
- …the product lifecycle. Provide senior staff advice and guidance on regulatory issues, especially for US . Responsible for oversight and strategic planning ... want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and...the employment eligibility of all new hires in the United States . Please click on the following… more
- Eisai, Inc (Nutley, NJ)
- …employers to electronically verify the employment eligibility of all new hires in the United States . Please click on the following link for more information: ... your profile, we want to hear from you. Associate Director , Medical Education - Oncology, is responsible for the...of these plans and activities will be either global, US -focused with intended use and adaptation by other regions… more
- Merck & Co. (Rahway, NJ)
- …Development Associate Principal Scientist - Development Strategy, Design Controls(Associate Director Equivalent) Our company's Device Development & Technology (DD&T) ... from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This position will interact… more
- Merck & Co. (Rahway, NJ)
- …integrating state-of-the-art technology and applying rigorous scientific and ethical standards.The Senior Director has primary responsibility for the planning ... to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new...to post-licensure). With a focus on late-stage development, the Senior Director will manage the entire cycle… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required Travel: Ability ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the ... direct reports, and mentors or acts as functional manager of skip-level or ex- US staff. This position requires strong knowledge about RBQM, and related processes,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/Associate Director , has primary responsibility for ... responsibilities also include development of American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers for use by local subsidiaries in… more
- Merck & Co. (Rahway, NJ)
- …as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines ,- strategies ... communicate with stakeholders at various levels, including cross-functional teams, senior management, external vendors, and clinical sites. Strong negotiation,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryThe Principal Scientist/ Director , Value & Implementation (V&I) Outcomes Research, position resides in the V&I organization, which includes ... Outcomes Research, and will support Pneumococcal Vaccines.Under the guidance of a senior leader, this position supports value evidence outcomes research plans and… more
- Merck & Co. (Rahway, NJ)
- …pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research ... with other teams within BPD and staff in Process Cell Science, US Operations, Clinical Manufacturing, and Commercial Manufacturing groups. The candidate should be… more
- Merck & Co. (Rahway, NJ)
- …data/medical protocol deviations in collaborations with the Clinical Director .Other responsibilities include:Collaborating cross-functionally in the development of ... engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Senior Engineer in Device Design and Process Development group, you will be part of our Research & Development team that designs and develops ... equipment and processes for medical devices/drug delivery systems. Reporting to the Director responsible for this area, you will partake in medical device assembly… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …4+ years of proven leadership experience managing technical and validation teams, preferably at Director or Senior Management level - Required 7+ years of strong ... electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards.… more
- Merck & Co. (Rahway, NJ)
- …available at its Rahway, New Jersey research facility. The Principal Scientist is a senior scientific role tasked with working closely with the group Director to ... and transfer using immunoassay techniques.Extensive knowledge and experience with regulatory guidance and industrial standards of control strategy for residual… more
- Crdit Agricole CIB (New York, NY)
- …Information Salary Range: $250k - $300k #LI-DNI Position location Geographical area America, United States Of America City NEW YORK Candidate criteria Academic ... / Financial Security Job title Head of Investment and Corporate Banking Regulatory Compliance ("ICBRC") Americas - Director Contract type Permanent Contract… more
- Metropolitan Transportation Authority (New York, NY)
- Description Position at MTA Headquarters POSTING NO. 11765 JOB TITLE: Senior Deputy Director , Tenant Management DEPT/DIV: Real Estate, Tenant Management WORK ... more subway and commuter rail cars than all other US transit systems combined. MTA strives to provide a...excellent customer service, and rewarding opportunities. Position Objective: The Senior Deputy Director of Tenant Management will… more
- Reworld (Florham Park, NJ)
- …disabilities), veteran status, liability for service in the Armed Forces of the United States , or any other characteristic protected by law. Know Your ... understanding of the wastewater industry, including treatment technologies, customer needs, regulatory requirements, and market trends. You will work closely with… more
- Clinical Dynamix, Inc. (Florham Park, NJ)
- Title: Sr. Director , Clinical Pharmacology Reports to: SVP, Clinical Development Location: US - Remote Position Overview: As Company continues to advance the ... teams and will contribute to the planning, implementation and organization of regulatory filings along with presentation of PK/PD data to internal cross-functional… more
