- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and inspections. Finally, this position has advanced skills in continuous improvement, project management , change management , and risk management ... manages risks for the function regionally and supports functional risk identification/ management efforts globally. Project Management :Contributes to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services Project Management and Operational Management .Develop a strong, ... Leads and the business users to define user information needs.Provide informatics project management , SDLC Quality Model expertise, and computer system… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Work closely with study site operational staff to ensure timely and accurate updates. Project Management : Demonstrate advanced project management skills, ... discussions with internal and external cross-functional teams. Present findings and project statuses to cross-functional leadership and alliance management … more
- Merck & Co. (Rahway, NJ)
- … compliance.-Essential Duties and Responsibilities:Program Leadership and Technical Project Management :Provide program leadership in the development, ... with a strong understanding of quality management systems and regulatory compliance.Exceptional project management skills and principled verbal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by ability to interpret SAPs/shells to generate ADaM and TLFs. preferred- Strong project management experience and ability to manage and execute multiple ... collaboration with other functional areas such as biostatistics, data management , clinical operations, pharmacovigilance, regulatory affairs, etc.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services, Project Management and Operational Management . Develop a ... functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management , Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Management and other business leaders with updates regarding same.- Leads cross-functional project management teams set up to address mid-sized to large ... but not limited to, areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside counsel as is… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or More Years related professional experience required.Must have professional experience Project Management , Clinical Supply Management , and/or Clinical ... generation and working with outsourcing to submit appropriate requirements on a Project basis.Vendor Management - support interactions with Vendors on packaging… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unified Global Clinical Science Strategy. In conjunction with Global RD Finance, Global Project Management , HR, manage the workforce planning for Global Clinical ... Partner and collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management , Regulatory Affairs, and other RD functions to ensure effective… more
- Merck & Co. (Rahway, NJ)
- …authority filings.Effective communication and leadership skills in a dynamic environment. Project management experience, including tracking, supporting, and ... and maintain a central repository for knowledge and life-cycle management of the program to support regulatory ...for large molecule batch release and stability testingExperience using project management , validation and EDMS solutions (eg… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …preferred Experience Qualifications- 7+ years of professional pharmaceutical experience in project management and operational support role and relevant ... in close collaboration with the QA Training and Documentation management team. This position will take direction from global...that may impact multiple Global organizational units or Global project teams. The incumbent may be tasked under the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …priorities simultaneously. preferred- 4 or More Years Extensive experience in project management , process, product, and/or analytical development activities and ... to budget, timeline, achievement of defined milestones and overall project risk management . He/she will assess ...1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …industry (preferably in a global company).10+ years of expertise in project management , process, product, and/or analytical development activities and ... at least 2+ years in a direct or matrix management position of a CMC-related function in the pharmaceutical/biopharmaceutical...oncology project development.Extensive knowledge of global CMC regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …excellence in managing multiple complex and competing priorities simultaneously. Proven project management and strategy skills. Is experienced in leading ... plans for specific categories under the direction of the head of category management , for the creation, execution, tracking of strategies. Includes working under a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and represent QCP on internal teams including Clinical Development Operations, Global Project Management , Bioanalysis, and Drug Metabolism to design, develop, ... and authoring reports and co-authoring primary and secondary sections of regulatory documents. The Manager, Clinical Pharmacology is expected to identify, generate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Experience Qualifications- 4 + years of professional pharmaceutical experience in project management and operational support role and relevant additional ... sensitive documents that may impact multiple Global organizational units or Global project teams. This position has advanced skills in technology systems, including… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to review all congress initiatives, timelines and deadlines for content and execution. Project management to ensure all business-critical deadlines are met for ... in pharmaceutical brand marketing, pharmaceutical industry, legal, compliance and regulatory , convention industry to provide recommendations, anticipate issues and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …skills with demonstrated ability to build collaborative relationshipsStrong project management skillsOrganizational awareness (eg inter-relationships of ... handles sensitive documents that may impact multiple organizational units or project teams. This position has advanced skills in technology systems, content… more
- Merck & Co. (Rahway, NJ)
- …and present ideas to senior leadershipExcellent communication, presentation, negotiation, project management , and organizational skillsExperience with leading ... products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional… more
