- Merck & Co. (North Wales, PA)
- Job DescriptionOur Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, efficient, and ... compliant drug/diagnostic regulatory strategies and approaches across geographies.Under direction of the Executive Director , Companion Diagnostics/In Vitro… 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 ad hoc member of Global Project Team (GPT) to address labeling issues… more
- Merck & Co. (Rahway, NJ)
- …understanding of the regulatory environment, and a-vision to influence the regulatory environment.Nature and Scope of Position:The Director reports to the ... chemical and biochemical promcesses, parenteral, oral, and specialty dosage formulations.- The director should be well engaged with regulatory and industry… 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 ... and dedicated colleagues while developing and expanding your career.The Clinical Director (Principal Scientist) has primary responsibility for the planning and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDescription:The Director of Chemical Engineering R&D is responsible for managing a portfolio of projects from the clinical pipeline, including ... pilot plant scale-up and activities to support technology transfer and regulatory filings. The incumbent will be responsible for the performance and… more
- Merck & Co. (Rahway, NJ)
- …Point, PA / Rahway, NJ is seeking a curious and collaborative Director to support our rapidly expanding cardiology respiratory, metabolism and ophthalmology ... pipeline.As a Director , you will serve as an expert QP2 representative...vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Director Safety & Environment The Rahway Environmental, Health, and Safety (EHS) Director is responsible for development and ... areas for global teams as part of the Corporate Headquarters.- The Rahway EHS Director is a member of the Rahway Site Coordination team and collaborates with key… more
- Merck & Co. (Durham, NC)
- …our core principle of Safety First and Quality Always.The Associate Director , Engineering/Maintenance will support a new drug substance manufacturing operation's ... operations and associated clean utilities and process equipment.- The Associate Director will manage tactical and strategic process, equipment, and qualification… more
- Merck & Co. (Rahway, NJ)
- …cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for ... of Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic… more
- Merck & Co. (Rahway, NJ)
- …across both diagnostics and pharma? Then you could be our new Global Marketing Director of Digital Diagnostics! - The Position: We are currently recruiting for a ... Marketing Director , Digital Pathology within our Precision Medicine, Global Oncology...across HH, our Research & Development Division, Medical Affairs, Regulatory , Legal etc. as well as external partners (diagnostic… more
- Merck & Co. (North Wales, PA)
- …& Division organization of our company.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core member of Early Drug Development ... & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive cross-functional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... the Target Product Profile (TPP)Development of clinical sections of trial-level regulatory documents (eg, response to HAs, briefing book, etc.) in conjunction… 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 the ... environment or scrum frameworkMarket research knowledgeKnowledge of our commercial, regulatory , and legal compliance policiesEnd-to-end medical/legal (PRT) review and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are currently recruiting for a Director , Global Marketing for Women's Cancer for the oncology portfolio.- The Global Marketing Director will ... chain: basic science and biology, clinical development and innovation, regulatory processes, global launch dynamics, access and reimbursement and… 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 &...strong network internally and across the external academic and regulatory community is expected, as well as advancing a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulated BA, DMPK, biological sciences, clinical pharmacology, BA strategic planning, regulatory guidance, and in- licensing and has managerial experience. This ... to oversee bioanalysis strategy from global development and global regulatory perspectives, set standards (industry best practices), ensures efficient… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description Associate Director , Automation The Associate Director Manufacturing Automation is responsible for managing the team in ... supply of product and on time project executionProviding direct support for regulatory inspections and audits and other validation activities by serving as the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation ... of developmental and regulatory strategy; Drafts protocol profiles and sections of key...Business Development activities for late stage compounds Involvement with in- licensing and acquisitions on individual due diligence activities; Contributor… 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 ... Sponsorship:No Travel Requirements: 25%Flexible Work Arrangements:HybridShift:1st - DayValid Driving License :NoHazardous Material(s):n/aJob Posting End Date:07/8/2024 *A job posting is… more
