- Fidelity TalentSource LLC (Boston, MA)
- …within the vibrant Fidelity Capital Markets trading floor? \u00A0We are looking for a Director of Regulatory Reporting , a leadership position within the team ... to determining the overall completeness and accuracy of the reporting we submit.\u00A0 The Director will act...and other business partners that have an impact on Regulatory Reporting . \u00A0\u00A0You will also maintain positive… more
- Fidelity TalentSource LLC (Boston, MA)
- …Description:The RoleAs a Director of Data Analytics, you will support the regulatory reporting process for Fidelity s broker dealers and various customer ... channels as part of the broader Regulatory Reporting group within Fidelity Capital Markets. This group is responsible for collecting, processing, and … more
- Insmed Incorporated (Bridgewater, NJ)
- …with Regulatory project leads in the US, EU, and Japan, the Director , Regulatory Labeling will be responsible for creating (and/or updating) labeling ... Best Workplaces for Millennials™ lists.OverviewThis is a key role providing regulatory expertise and guidance to internal stakeholders for successful development and… more
- Creative Financial Staffing (Columbus, OH)
- …effective program implementation and ensure the quality of financial reporting both internally and externally. Position Responsibilities: Oversees all accounts, ... ledgers, and reporting systems ensuring... systems ensuring compliance with appropriate GAAP standards and regulatory requirements. Maintains internal financial control and auditing regarding… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a difference?The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational medicines. You ... will lead a global regulatory team to develop and execute regulatory ...to lift 0-10 lbs. Development of People Ensure that reporting personnel have individual development plans (IDP), with annual… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key ... Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation ... of developmental and regulatory strategy; Drafts protocol profiles and sections of key...3 studies: Collaborates with CSPV to ensure monitoring / reporting of AEs/SAEs, Reviews safety reports/data during study conduct,… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Associate Director , Omnichannel Marketing and Media position reports to the Senior Director , Omnichannel ... deliver omnichannel and media specific marketing input and activities.The Associate Director of Omnichannel Marketing and Media is responsible for managing,… more
- Merck & Co. (Rahway, NJ)
- …the delivery of high quality and compliant statistical analysis and reporting .Direct the activities of programmers whose predominant accountability is the ... vaccine programs.Interact with cross functional scientists including, Statistics, Clinical, Regulatory , QP2, CSRM, Data Management and Statistical Programming to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) Group Lead will ... lead will also contribute to the program study strategy, planning, execution, and reporting outputs in collaboration with the CS Asset LeadsThe CS Group Lead will… more
- Insmed Incorporated (Bridgewater, NJ)
- … Director , Toxicology, is a key member of the nonclinical safety team, reporting to the Executive Director , Head of Toxicology and Molecular Mechanisms. In ... discipline. DABT/DACVP certification preferred.Minimum of 10 years of experience as a regulatory toxicologist (study director /monitor and/or project lead) in the… more
- Catalent (Harman, WV)
- Senior Director , Supply Chain Position Summary: The Senior Director , Supply Chain is responsible for leading the supply chain organization for Catalent Maryland. ... ten suites actively operating and eight additional suites coming online. Reporting to the Vice President and General Manager, the...to the Vice President and General Manager, the Senior Director Supply Chain directs all facets of supply chain… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …focusing on optimizing patient care and support. Relationships Reports to the Director of PSP Analytics and Ops Excellence. Key internal relationships include ... patient support programs data strategy aligns with organizational goals and regulatory requirements, working closely with key stakeholders to drive impactful change… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... the Target Product Profile (TPP)- Development of clinical sections of trial-level regulatory documents (eg, response to HAs, briefing book, etc.) in conjunction with… more
- Merck & Co. (Rahway, NJ)
- …on automation within Biologics Process Research & Development (BPR&D).The Associate Director role-will provide process automation leadership within the BDC Pilot ... automation systems.-Integration of control systems with MES, Quality, and Batch Reporting applications.Understand and adhere to CFR, GMP, and data integrity… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …team; Ensure the interpretation of statistical results and provide input on reporting (CSR) to support Medical Affairs and HEOR/HTA strategies: Plan, set-up and ... Statistical deliverables. Contribute, with limited supervision, to documents submitted to Regulatory or Pricing Authorities. May participate as subject matter expert… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics ... communication/publication components of overall medical operating plan.The Sr Medical Director provides strategic development, planning, implementation, and oversight of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …OR rep licensure), NNI government agreements (eg Corporate Integrity Agreement (CIA)) regulatory requirements (eg PDMA reporting ) and the systems that support ... training on new procedures, to auditing against local and corporate policies, to reporting compliance-related issues, ECP keeps us accountable every step of the way… more
