- Eisai, Inc (Nutley, NJ)
- …assesses and provides objective risk assessments and guidance regarding Eisai's compliance with regulatory , organizational, and commercial requirements that ... compliance initiatives (strategic and execution).Assess and guide on compliance with regulatory , organizational, and commercial requirements.Define and… more
- Eisai, Inc (Nutley, NJ)
- …and close-out) under the direction and supervision by study Clinical Operations Lead (s). Plans, support , creates, and communicates clinical study timelines. Gathers ... line managers when issues develop. Implements and prepares the clinical development strategy as outlined by the clinical teams. May develop recruitment strategy… more
- Merck & Co. (Rahway, NJ)
- …strategic direction of the company's product pipeline and regulatory strategy .Drive operational excellence initiatives that improve quality, compliance , and ... and implement continuous improvement strategies for device quality and regulatory processes.Monitor and ensure compliance with global regulations… more
- Merck & Co. (Rahway, NJ)
- …other parts of the AR&D organization in aspects of quality control and compliance . Your main responsibilities will include: - Strategy and Operational ... exciting opportunity for a Director role as GxP Strategic Lead based in Rahway, NJ. Join us and experience...needs, which can include impact of the external business, regulatory , and compliance environment. Promoting our company's… more
- Merck & Co. (Rahway, NJ)
- …ResponsibilitiesLead/contribute to device development, design controls and risk management strategy for the assigned projects.- Lead the implementation and/or ... approaches within Device Development and with external suppliersUnderstand and apply regulatory / compliance requirements relative to design controls and… more
- Merck & Co. (Rahway, NJ)
- …and injectors) and secondary packaging. Candidate will develop and oversee CCI strategy for our Company's combination product pipeline, inclusive of small molecule, ... product presentations and be familiar with current industry and regulatory standards/best practices and innovative approaches for demonstration of container-closure… more
- Merck & Co. (Rahway, NJ)
- …pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product ... portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy , lead activities, and develop a team that will build… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …amount of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service ... various contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global ... inspections Management Strategy and Goals:Assist in developing PV goals, continued compliance , and strategy for process improvement initiatives as a member… more
- Merck & Co. (Rahway, NJ)
- …will work closely with internal stakeholders-including sales, product development, and regulatory teams-and external partners to ensure cohesive strategy ... of PositionThe Parasiticides Marketing Director will manage a complex go-to-market strategy across a diverse portfolio of leading brands in the parasiticide… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... 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)
- …input on activities such as target product profile development, global regulatory filing strategy , launch readiness reviews, organized customer interactions, ... globally. We are currently recruiting for an Associate Vice President (AVP) to lead global marketing for our Global Ophthalmology Franchise.For more than 35 years,… more
- Merck & Co. (Rahway, NJ)
- …for non-sterile and sterile products.- It also includes strategic partnering with CMC and Regulatory in aspects of control strategy and filings, Quality and our ... In this position the SMAR&D Director will set guidance, lead activities, and develop a team whose roles include...dosage formulations.- The director should be well engaged with regulatory and industry trends to guide future activities for… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThis position drives scientific planning, strategy and execution of Phase 1-4 clinical studies. Under the direction of the Program Lead , you will ... team members including clinical directors and study managers to lead /support clinical trial scientific activities in the Atherosclerosis & Metabolism… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …EMA, Swiss medic, and other local authorities as necessary to address compliance relevant matters and lead any remediation efforts. ResponsibilitiesLeads ... Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents… more
- Merck & Co. (Rahway, NJ)
- …Description: Associate Director, Clinical Scientist This position drives scientific planning, strategy and execution of Phase 1-4 clinical studies. Under the ... direction of the Program Lead , you will collaborate with global, cross -functional team members including clinical directors and study managers to lead /support… more
- Merck & Co. (Rahway, NJ)
- …of Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and ... Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic partnering… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …management and performance of CRO; Participates in creation of developmental and regulatory strategy ; Drafts protocol profiles and sections of key submission ... matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead . ResponsibilitiesStudy Strategy : Clinical study leader (CSL) or major… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to developing clinical data collection tools.Responsibilities- Leadership, Direction, and Strategy : Leads implementation of Program / Therapeutic level clinical data ... Data Governance bodies to ensure DS Data Standards are aligned with regulatory requirements and the organizational policies and procedures. Promotes Daiichi Sankyo… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy ; Develops biomarker strategy ... complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans,… more
