- Eisai, Inc (Nutley, NJ)
- …and recommend appropriate technologies and platforms to accommodate evolving regulatory requirements, user needs and business and functional requirements. Lead ... Demonstrated skills in helping negotiate priorities and resolving conflicts among project and functional stakeholders. Demonstrated ability to influence and drive… more
- Merck & Co. (Rahway, NJ)
- …systems, and coordinating CDS technical initiatives. Supporting the clinical database manager /supervisor in project planning, manpower projections, and resource ... maintain good working relationships across different functional areas. Solid project management skills. Excellent leadership, verbal and written communication,… 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)
- Job DescriptionAs a Design Control and Risk Management Data Manager , you are a key member of the Device Development Team. Your will main responsibility is to develop ... post market. -Support second person review with source data for regulatory filing.Support Design Transfer and Manufacturing readiness.Manage data management approval… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you ready to make a difference? The Position We are looking to hire a Clinical Project Manager (CPM). This is a unique opportunity to work in a growing Clinical ... in the pharmaceutical industry Minimum 2 years of experience as a Clinical Trial/ Project Manager Experience with global clinical trial operations, in multiple… more
- Eisai, Inc (Nutley, NJ)
- …and recommend appropriate technologies and platforms to accommodate evolving regulatory requirements, user needs and business and functional requirements. Lead ... Demonstrated skills in helping negotiate priorities and resolving conflicts among project and functional stakeholders. Demonstrated ability to influence and drive… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global ... of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service Provider… 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 ... but not limited to conduct of gap & impact assessment and developing project scope and project plans.Work cross-functionally with stakeholders to identify when… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …their needs and factoring regional needs, laws, and requirements.- Collaborate with the Project Manager (PM), HCP Engagement IT Operations team and business ... addition, this role will streamline business requirements, evaluate, and prioritize project and change request timelines, and ensures seamless integration with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …sensitive documents that may impact multiple Global organizational units or Global project teams. This position has advanced skills in technology systems, including ... projects assigned to individuals are current and up to date- Support regulatory inspection related activities as required such as organizing CAPA coordination teams,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: Manager , Sales Training and Development - Oncology serves as the training subject ... and ensure all projects and materials have been through the correct regulatory review process before being delivered to field sales forces.Support secondary customer… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as marketing mix align with the Brands' goals and objectives.- Regulatory approvals: Responsible for PMRT (Product Material Review Team) PGC (Promotional Grant ... and tactics aligned with the payer/brand strategy- Effectively manage budgets and project timelines Qualifications: Successful candidates will be able to meet the… more
- Tris Pharma (Monmouth Junction, NJ)
- …our Monmouth Junction, NJ headquarters has an immediate need for an experienced Product Manager or SR Product Manager . The SR/Product Manager contributes to ... pipeline, as appropriate.ESSENTIAL FUNCTIONS Successfully supports promotional campaigns and project management initiatives by developing and implementing promotional projects… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Future Business Strategy, Commercial, Account Management, Analytics, Legal, Regulatory , Investor Relations, Value Communication and Contracting Strategy colleagues, ... routine basis. Close relationships with Global Market Access and Pricing, the Global Project Teams (GPT) and Core Commercialization Teams (CCT) for launch brands may… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... and serves as ad hoc member to the Global Project Team for late stage projects. This position manages...Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …access, commercial effectiveness, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs, Government Affairs ... have solid understanding of the pharmaceutical marketplace including legal, medical, regulatory and clinical processes Develops accurate short- and long-term plans,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …apply unique business insight to create competitive advantage for the organization Project Management: Works in partnership with internal and external teams to ... projects on time and budget through effective management of the project timeline, issues, risks, dependencies, and deliverables Stakeholder Engagement &… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …development and life cycle management. Represents the function in global regulatory /heath authorities' meetings. High-level negotiation and oversight of CROs and ... career, of direct reports, and mentors or acts as functional manager of staff resides in other offices as needed.Responsibilities:Protocol Development, Statistical… more
