- Merck & Co. (Rahway, NJ)
- …Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed. Performs Quality ... of the TA Head or CRD Requires strong understanding of local regulatory environment. Strong scientific and clinical research knowledge is required. Strong… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThis position contributes to the operational planning and execution of one or more clinical trials. In this position, you will have the opportunity to ... multiple studies (eg, operational deliverables, clinical & ancillary supplies planning /tracking, lab specimen tracking, status update reports, study closeout… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders.Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) provides planning and coordination supports for global ... and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global … more
- Merck & Co. (Rahway, NJ)
- …materials characterization Recruit and develop talent Be proactive in resource planning , risk assessment strategies and budget management as necessary (including ... merit and promotion planning ).- Maintain a strong network internally and across the...strong network internally and across the external academic and regulatory community, advance a culture of scientific excellence, Good… more
- Merck & Co. (Rahway, NJ)
- …our products. The successful candidate will be accountable for proactive resourcing planning , risk assessment strategies and will focus on talent development and ... and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality...of Company policy. The Executive Director will be a manager of managers, with keen focus on coaching and… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. The Sr. Product Manager (SPM), US Oncology Women's Cancer, is responsible for contributing to the strategic ... communications and strategies across the brand's target audiences and to ensure regulatory /legal requirements are met. The SPM will lead efforts on developing… more
- Merck & Co. (Rahway, NJ)
- …systems, and coordinating CDS technical initiatives. Supporting the clinical database manager /supervisor in project planning , manpower projections, and resource ... new processes and technologies. Broad knowledge of Clinical Development and Regulatory Affairs requirements. The ability to multi-task, work independently, and… more
- Lundbeck (Long Branch, NJ)
- …transform lives. Join us on our journey of growth!As a Psychiatry Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... and must demonstrate strong capability in the following areas:ESSENTIAL FUNCTIONS: Business Planning & Account Leadership - Ability to use digital tools and apply… more
- Eisai, Inc (Nutley, NJ)
- …& Architecture, s/he is the Global IT department's trusted leader and manager who assesses and provides objective risk assessments and guidance regarding Eisai's ... compliance with regulatory , organizational, and commercial requirements that govern the organization's technology systems and information assets.Purpose of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. The position will perform validation of the electronically… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …adequate systems and process support, including facilitation of respective regulatory inspection preparation, management and follow-up in collaboration with impacted ... flow based on read outs from audits, inspections, Quality Events, regulatory intelligence, effectiveness checks on process implementations and metrics. Support… more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems ... not limited to: investigative processes, CAPAs and CPIs, etc.Participates in regulatory agency inspections and customer audits, as needed; Performs and/or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for support and manage Quality Management System (QMS) in accordance with regulatory requirements and to ensure the adherence to the Quality Manual. Responsible ... adherence to the implementation of global and harmonized Quality Standards and regulatory requirements for GMP area. Responsible for the creation and review Quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …competing priorities Strong knowledge of consumer/patient engagement channels and regulatory considerations Content Planning , Execution, and follow-through ... in? Are you ready to experiment with us? The Position The Consumer CX Manager will be a critical driver in ensuring the successful execution of brand/therapy area… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across competing priorities Strong knowledge of HCP engagement channels and regulatory considerations Content Planning , Execution, and follow-through skills ... you in? Are you ready to experiment with us? The Position The HCP CX Manager will be a critical driver in ensuring the successful execution of brand/therapy area… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Centers of Excellence, Corporate Communications, etc.) Also interacts with Sales, Medical, Regulatory , and Legal. The Manager leads, manages, and directs a ... teams and other key functional areas of the organization in the planning , submission, review and approval, distribution and lifecycle management of promotional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Job Summary The Biosample Operations Manager , Biosample Management is responsible for supporting the oversight of the ... sample tracking, site escalations, query resolution, and missing samplesSupport the planning and coordination of activities required to manage the lifecycle of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of presentation, meeting agenda and meeting minutes.May be delegated for logistic planning and coordinating the QA Meeting which including the QA leadership meeting, ... projects assigned to individuals are current and up to date- Support regulatory inspection related activities as required such as organizing CAPA coordination teams,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Market Access (MAPA), to co-create strategies for a cohesive portfolio planning , device strategy and indication management. Facilitate communication and coordination ... decisions, including market trends, competitive dynamics, patient needs, and regulatory requirements. Stay abreast of industry developments, emerging technologies,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
