- Eisai, Inc (Nutley, NJ)
- …Diagnostics Pathway Educational Campaign and TacticsDevelop, implement, and manage Global diagnostic pathway educational strategy, campaign, and tactics in concert ... with the Global Leqembi brand marketing team.Drive alignment between ...with cross-functional colleagues including Medical, Market Access, Legal, and Regulatory as required 2. Management of Diagnostic Company Partnership… more
- Merck & Co. (Rahway, NJ)
- …Coordinate & facilitate upskilling to embed critical capabilities (to support the PPS director conduit from HHDDA) on behalf of Global Oncology dept. (ie-L3, ... submissions, timelines, development of deliverables for markets-- Partner closely with Global Tumor/Brand teams to assimilate L3 Next outputs to identify strategic… more
- Merck & Co. (Rahway, NJ)
- …with worldwide regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more our company's ... final approval of all submissions and associated documentation.Provides expertise as the Global Regulatory Lead to Product Development Teams and regulatory… more
- Merck & Co. (Rahway, NJ)
- …are seeking a highly skilled and experienced professional to join our team as an Associate Director for our Digital Forensics Lab. The Associate Director ... all activities are conducted efficiently and in compliance with legal and regulatory requirements. Manage and provide technical guidance to a team of digital… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to date- Support regulatory inspection related activities as required- Support Head, Global strategy and operations to develop and plan the Global QA ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...responsibility to collaborate with, and support the head of Global QA strategy and operations. In this position, the… more
- Merck & Co. (Rahway, NJ)
- …Pharmacology and Pharmacometrics - Immune/Oncology team in the role of Associate Director . The team is part of the Global Clinical Development organization ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the Group will work closely with teams of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders.Summary The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...serve as G-RACMC lead or regional submission lead. Provide regulatory guidance and strategy to CMC sub-team and G-RA… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …agreed quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… more
- Merck & Co. (Rahway, NJ)
- …of decision-making at our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate ... on a continuous basis in decision making and driving pipeline impact. The Associate Director will perform job duties independently with minimal supervision… more
- Merck & Co. (Rahway, NJ)
- …to bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The Director selects, trains, and ... Job DescriptionThe Director of Biologics Potency in Analytical Research &...responsible for a team of approximately 10-15 senior and associate level scientists in Rahway, New Jersey. -The position… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the ... and enforcement of data standards, demonstrated knowledge of industry standards related regulatory requirements (CDISC), FDA & ICH, PMDA, EU & ICH, CRP and… more
- Merck & Co. (Rahway, NJ)
- …reliance on automation within Biologics Process Research & Development (BPR&D).The Associate Director role-will provide process automation leadership within the ... GMP, and data integrity regulations to ensure compliance with regulatory requirements.Develop and maintain SDLC documentation.Actively work in a multi-discipline… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …lifecycle.Applies GCP principles to ensure all medical coding activities follow global SOPs, SOIs, and associate guidelines.Qualifications: Successful candidates ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... value from inception through to implementation. Demonstrates ability to handle global projects through established interactions with Japan and Europe as required.… 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 serve as an ad hoc member of Global Project Team (GPT)… 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 ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (Rahway, NJ)
- … regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre-clinical and translational work for ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... analysis data structures and analysis tools requirements, simple disease models, regulatory guidelines pertaining to M&S, and programming and analytical software.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and maintaining awareness of best practices for reproducible data science, global regulatory requirements, internal guidelines and Standard Operating Procedures ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing ... hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and Pharmacometrics/… more
