- 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)
- …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)
- …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)
- …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
- 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
- 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
- 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
- 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)
- …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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and leads/contributes to internal statistical workstreams to address various project needs. The position works closely with contract research organization ... team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical… 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
- 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
- Engage Partners, Inc. (New York, NY)
- …the collection, processing, review, and TAR for client data. The Litigation Support Project Manager manages the full litigation life cycle, including eDiscovery ... full-service law firm that has earned a solid reputation for complex litigation, regulatory and transactional work on behalf of clients in important and growing… more
- Motion Recruitment Partners (New York, NY)
- Regulatory Project Manager New York, New York **Hybrid** Contract $122/hr - $130/hr Grow your career as a Regulatory Project Manager with an ... 6+ Months **Required Skills & Experience** + Bachelor's/University degree. + Regulatory understanding and experience with regulatory interpretation. + Market… more
- Motion Recruitment Partners (New York, NY)
- Regulatory Project Manager New York, NY **Hybrid** Contract $80/hr - $85/hr Grow your career as a Regulatory Project Manager with an innovative ... + Bachelor's/University degree. + 8+ years of experience in project management working with major banks, preferably in a...+ Tier 1 Bank or Big 4 experience. + Regulatory Change or transformation work. + Ability to lead… more
- Catalent Pharma Solutions (Somerset, NJ)
- ** Regulatory Affairs Project Manager ** **Position Summary** Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical ... business continues to grow and expand. Catalent Pharma Solutions is hiring a Regulatory Affairs Project Manager **.** The Regulatory Affairs Project … more
- Motion Recruitment Partners (New York, NY)
- Regulatory Business Analyst / Project Manager New York, New York **Hybrid** Contract $73/hr - $78/hr Grow your career with an innovative global bank in New ... York, NY for a hybrid as a Business Analyst/ Project Manager with extensive Regulatory experience. Contract role with strong possibility of extension. Will… more
- Veolia North America (Kearny, NJ)
- …water for administrative purposes and regulatory agencies. + Participates and supports Project Manager in client meetings as needed and helps to handle ... keep client informed and enhance client relations. **Primary Duties/Responsibilities:** + Assists the Project Manager in the daily operation and maintenance of a… more
