- Lundbeck (New York, NY)
- …psychiatry. It is a very exciting time to join our team as we lead the way in creating positive customer experiences!As a BioPharmaceuticals Account Manager, you ... lead the promotion of our infusion product, driving demand...apply customer and data-based insights to build opportunities, develop strategy & tactics and prioritize resources to enhance territory… more
- Eisai, Inc (Nutley, NJ)
- …educating end-users on compliance requirements. Additionally, you manage regulatory compliance activities, maintain accurate documentation, and evaluate new ... crisis management.Manage IT training programs and conduct Segregation of Duties reviews. Regulatory Compliance Activities:Collaborate with legal and compliance… more
- Merck & Co. (Rahway, NJ)
- …US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy .Providing quality advice to stakeholders ... an effective implementation and oversight model to maintain best-in-industry regulatory compliance .The Vice President Regulatory Affairs,… more
- Merck & Co. (Rahway, NJ)
- …limited to:Reports to Executive Director or Associate Vice President, Therapeutic Area Lead .Develops worldwide product regulatory strategy to optimize label ... growth mindset. The Director, Regulatory Affairs Liaison is responsible for:Developing regulatory strategy for their assigned products, in order to optimize… more
- Merck & Co. (Rahway, NJ)
- …products.-- Providing labeling expertise and guidance to teams while ensuring compliance with applicable regulatory requirements- Serving as regulatory ... Affairs sub-teams to ensure delivery of labeling documents that meet quality and compliance standards and regulatory labeling requirements to support timely … more
- Merck & Co. (Rahway, NJ)
- …and implement robust SAP security policies, procedures, and controls.Ensure compliance with regulatory requirements and industry best practices.Manage ... the EIT SAP Platform Team, the EIT SAP Technology Lead will assume the crucial role of leading all...They will also have responsibility for the end-to-end Upgrade strategy from roadmap to execution for the entire SAP… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to data governance to ensure data integrity, quality, consistency, and compliance with regulatory requirements.Define data governance principles, policies, and ... as other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …amount of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service ... various contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global… more
- Lundbeck (Bronx, NY)
- …Join us on our journey of growth!As a Neuroscience Account Manager, you lead the promotion of our psychiatry portfolio to Psychiatrist and Institutional Accounts ... use digital tools and apply data-based insights to create opportunities, develop strategy & tactics, allocate resources to enhance sales execution, monitor progress… more
- Merck & Co. (Rahway, NJ)
- …are completed with the highest regard for safety, quality and regulatory compliance . Qualifications: Education Minimum Requirement: PhD and/or Post-doc ... both personally and through mentorship of others, and in driving the scientific strategy of the CBT group. The Senior Principal Scientist manages and prioritizes a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned… more
- Merck & Co. (Rahway, NJ)
- …for non-sterile and sterile products.- It also includes strategic partnering with CMC and Regulatory in aspects of control strategy and filings, Quality, and our ... formulation development.- In this position, the SMAR&D Director will set guidance, lead activities, and develop a team whose roles include the-development of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …management and performance of CRO; Participates in creation of developmental and regulatory strategy ; Drafts protocol profiles and sections of key submission ... matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead . ResponsibilitiesStudy Strategy : Clinical study leader (CSL) or major… more
- Merck & Co. (Rahway, NJ)
- …1)-low patient recruitment, 2) inadequate staff to meet business needs, 3) performance or- compliance issues, 4) working with regulatory issues and the broader ... and project management for-assigned protocols in a country in compliance with International Conference on Harmonization Good Clinical Practice(ICH/GCP) and… more
- Merck & Co. (Rahway, NJ)
- …contributor, shape and realize innovation across the Biologics' pipeline, strategy , and scienceAdvance the pipeline by collaborating with cross-functional teams, ... Research & Manufacturing, in a fast-paced, multidisciplinary environmentParticipate in or lead 1) development of robust and scalable upstream processes for biologics… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of the Oncology and Specialty Medicine portfolios, in alignment with the business strategy . Lead the PV inspection management activities by ensuring readiness, ... preparedness for the respective PV inspections in alignment with regulatory and company strategy .Act as the management...that all functions consistently operate in a state of compliance .Facilitate the implementation of the quality strategy … more
- Merck & Co. (Rahway, NJ)
- …(ESG) Third Party Risk Reporting as requiredEngages with the Enterprise Strategy Office, Corporate Audit and Assurance Services (MCAAS), and various Divisions ... fieldRequired Experience and Skills: Minimum 7 years in Procurement, Compliance , Quality, Technology, Manufacturing/Operations, Supply Chain or related Business… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with CRO senior leadership as needed; Participates in creation of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts ... matters; Supports marketing in developing a commercial strategy include biomarker strategy ; Represents Clinical Development as Global Clinical Lead or as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and enforcement of data standards, demonstrated knowledge of industry standards related regulatory requirements (CDISC), FDA & ICH, PMDA, EU & ICH, CRP and ... processes. Working knowledge of early and late-stage submissions per local/ regulatory requirements, demonstrated ability to self-start, be solution-oriented with an… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …accuracy and consistency of the coded data, and adherence to regulatory authorities' requirements.Ensure compliance with the protocol, external/internal ... delivery of medical coding for clinical trials, clinical development, and regulatory submissions. Develops and proposes strategies for medical coding and coding… more
