- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.SummaryThe Associate Director , Regulatory Operations - Dossier Planning ... INDs, original and supplemental NDAs/BLAs/MAAs. The Associate Director partners with the Head of Regulatory ... Director partners with the Head of Regulatory Operations in developing processes and standards… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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...and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling… more
- Merck & Co. (Durham, NC)
- …world with our core principle of Safety First and Quality Always.The Associate Director , Engineering/Maintenance will support a new drug substance manufacturing ... unit operations and associated clean utilities and process equipment.- The Associate Director will manage tactical and strategic process, equipment, and… more
- Genmab (Princeton, NJ)
- …Role The Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group ... within Regulatory Affairs (RA) to ensure timely and high-quality document...to ensure timely and high-quality document delivery to the Regulatory Publishing Group. You will oversee the implementation of… more
- Merck & Co. (North Wales, PA)
- …the Research & Division organization of our company.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core member of Early Drug ... progress the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Director US Oncology Marketing Digital Engagement will direct the identification, design, execution, oversight, and optimization of ... environment or scrum frameworkMarket research knowledgeKnowledge of our commercial, regulatory , and legal compliance policiesEnd-to-end medical/legal (PRT) review and… more
- Insmed Incorporated (San Diego, CA)
- …to the Executive Director of Program Management, the Associate Director , Program Management supports the cross-functional drug development ... in accordance with the program strategy. In addition, the Associate Director of PM may be asked...with proven management and/or leadership experience in an R&D, Regulatory , manufacturing/ operations or commercial context in a… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description Associate Director , Automation The Associate Director Manufacturing Automation is responsible for managing the team ... product and on time project executionProviding direct support for regulatory inspections and audits and other validation activities by...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas ... the Technical Operations team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will… more
- Merck & Co. (North Wales, PA)
- …review processes) including experience including bringing materials through legal, regulatory , and clinical review Strong project management skills as demonstrated ... in face-to-face meetings, then your employment may pose an undue burden to business operations , in which case you may not be offered employment, or your employment… more
- Merck & Co. (Rahway, NJ)
- …functional / business requirements for solution design for planning, warehouse operations , distribution, ensuring compliance with market requirements as global ... regulatory requirements continue to evolve. Develops subject matter expertise...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Clinical Operations (GCO) Procedural Ownership ... policies, and meet applicable ICH and GCP standards. The Associate Director will also be responsible for...experience in one or more key functions (eg clinical operations , clinical research, clinical science, and/or CQA). Strong experience… 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 ... on Component teams and/or serve as G-RACMC lead or regional submission lead. Provide regulatory guidance and strategy to CMC sub-team and G-RA teams along with other… more
- Merck & Co. (Rahway, NJ)
- …products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional ... integration of the device development activities with the clinical, regulatory , formulation, commercial and other key company functions.Represent Device Development… more
- Merck & Co. (Rahway, NJ)
- …the organization in 2023.We are seeking a leader to take the position of the Associate Director Global Marketing, who will be responsible for maximization of the ... late lifecycle opportunitiesSupport filing of new indications and other regulatory requirements, such as pediatric filingsCross-functional collaboration: foster strong… more
- Merck & Co. (North Wales, PA)
- …innovative medicines that help people around the globe. We are currently recruiting for Associate Director , US Marketing, HCP Strategy for HIV. Our company has ... to drive and align on decisions, including field sales, marketing operations , Legal, Regulatory , Medical, etc. Our US marketing team has adopted an Agile… more
- Merck & Co. (North Wales, PA)
- …cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.-Specifically, the Director may be ... statistics, and manufacturing to manage clinical development projects; andAssist the Senior Director , Executive Director , and/or Associate Vice President in… more
- Merck & Co. (Rahway, NJ)
- …the Quantitative Pharmacology and Pharmacometrics - Immune/Oncology team in the role of Associate Director . The team is part of the Global Clinical Development ... 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)
- …collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations , Clinical Leads and Regulatory Liasions to ensure ... sucessful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review of documents supporting CDx submissions to… more
- Merck & Co. (North Wales, PA)
- …you collaborate with copy, design, UX, architecture, internal legal, medical and regulatory teams in the co-design, co-creation, and execution of campaign plans ... in face-to-face meetings, then your employment may pose an undue burden to business operations , in which case you may not be offered employment, or your employment… more
