- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases 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 … more
- Merck & Co. (Rahway, NJ)
- …to the project . This is an unmatched opportunity to build your career as a project manager in a highly complex and important field. You will be given the ... what GPAM does and our impact to the business. Direct experience as a project manager for a development pipeline asset.- Mentoring & networking opportunities… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Supervise designated personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. Develop ... packages for FDA meetings (pre-IND, EOP 2, pre-NDA, pre-BLA) for review by Project Leaders Write Regulatory documents translating team strategy into … more
- Aequor (Thousand Oaks, CA)
- …projects, programs or directing the allocation of resources. COMPETENCIES/SKILLS: Project management skills, Strong organizational skills, including ability to ... group. Ability to evaluate documentation/ operations according to company and regulatory guidelines Ability to interact with regulatory agencies. Demonstrate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global ... business requirements for reporting and analyticsEngage with key stakeholders, including Regulatory Affairs teams and cross-functional project team members, to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Project Manager , Accelerated Efficiencies and Optimization, will drive execution of Novo ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one...Director - Accelerated Efficiencies and Optimization, Strategic Operations. The Project Manager regularly works with members of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Project Manager , Process Engineer- Consultant as part of the Global MSAT team ... only technology vendor partners, but with Manufacturing, Process Development, Quality, and Regulatory to ensure approval of the selected platform. The candidate will… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help ... functional excellence activities to include, but not limited to, the project management of workstreams and strategic imperatives, training and onboarding, metrics… more
- Aequor (Thousand Oaks, CA)
- …and procedures, providing support and corrective actions where required Assists overall Project Manager with all matters related to strategic sourcing and ... as liaison between Project Delivery teams and suppliers Develop and maintain Project Sourcing Plan with Project Manager as a \"living document\"… more
- Merck & Co. (Durham, NC)
- …shop floor leadership.-Key Responsibilities for a Drug Product Operations Manager Accountability - Project SupportFirst-line operations supervisor with ... Job DescriptionThis role is within a capital project start-up in Durham, North Carolina. The new...the design and construction of the facility, the Operations Manager will play a critical role in supporting the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is responsible ... Clinical Team, the inspection preparation team, and transversal clinical improvement project working groups which are established to ensure continued inspection… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, NJ)
- …this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience working on Phase I-IV studies ... Finally, this position has moderate skills in continuous improvement, project management, change management, and risk management. Responsibilities Leadership,… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- Merck & Co. (North Wales, PA)
- …skills as part of a global, cross-functional team. You will apply project management, communication, and collaboration skills in-support of our clinical trials. Job ... any study specific partners and/or vendors.Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ensure deliverable quality, and expedite the preparation of oncology compound regulatory submission. It will also to maintain institutional knowledge across oncology ... (ISS) for oncology submission compounds, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) annotation… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Study Manager - Epidemiology OperationsSupport the Lead Epi Scientists by providing overall operational support for study ... produce safe, effective, innovative medicine.Primary responsibilities include:Operational planning and project management of epidemiology research studiesExecution, and close out… more
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. ... protocols, and protocol amendments often acting as the compound leadLead project management for medical writing deliverable by defining milestones, managing budget,… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …products reach the people who need them most. The Position As the Manager , Content Operations, you will support Novo Nordisk's strong commitment to its Omni-channel ... operational viability of the product, and anticipating future business needs. The Manager will be responsible for providing content feasibility insights to support… more
