- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal workflows and performance metrics to ensure departmental KPIs and regulatory compliance are consistently met Audit & Inspection Readiness Support the ... working relationships within Intake and Triage, Medical Review, Submissions and Compliance , Global Safety, and centralized teams (eg, Training and Documentation,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …sources. The Director is responsible for mentoring coaching and meeting the compliance requirements for the Medical Review Team. Relationship Reports directly to ... with Promotional Review Board as required. Essential Functions Leadership & Oversight Lead and manage the Medical Review Case Processing team, fostering a culture… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and internal customer alignment as necessary. The position is responsible for: Lead support for development of gross-to-net forecasts for Rare Diseases portfolio and ... of data and new data sources used in analyses, generating new insights Controls, Compliance and Finance Responsible for ensuring that all rebate controls meet all … more
- Tris Pharma (Monmouth Junction, NJ)
- …research and documentation; Drafts white papers and accounting memos to support audit and regulatory compliance Provides guidance on new accounting ... team responsible for leading core accounting functions and driving accuracy, compliance , and efficiency across the department. This role has direct ownership… more
- Merck & Co. (Rahway, NJ)
- …Auditing and Supplier ManagementThe Director will report to the Animal Health Global Quality Lead for Compliance and Technical Support and will direct the below ... training and continuing education programs.Coordinate with Site Quality leads on audit refusals and postponements. Lead project initiatives to maintain the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Medical Affairs team, ensuring collaboration with other GxP QA functions (eg, GMP/IMP QA, Audit and Compliance , QMS QA, Development QA, and PVQA) to address ... of clinical development processes through KQIs, demonstrating process control and ensuring compliance levels are met. Lead the process for reviewing and assessing… more
- Genscript USA Inc. (Piscataway, NJ)
- …collaboration with cross-functional teams is essential to ensure supply continuity, compliance with quality and regulatory standards, and readiness for audit ... direct procurement team to ensure smooth daily operations and compliance with SLA and KPI targets, and effectively manage...to meet inventory KPIs while ensuring continuity of supply. Lead strategic sourcing and manage the procurement process for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams on key milestones relating to the tracking of a particular signal(s) to ensure compliance with global Sops. Lead the maintenance of signal tool and support ... the material content of any documents sent to regulatory authorities. Provides compliance metrics to management, as needed. Lead continuous improvement around… more
- Merck & Co. (Rahway, NJ)
- …Expert (SME) - Associate Director, will report to the Animal Health Global Quality Compliance and Technical Lead .-- The responsibility of this position is across ... Site Quality Head at a USDA governed siteRequired Skills: Animal Health Care, Audit Inspections, cGMP Regulations, GMP Auditing, GMP Compliance , GMP Operations,… more
- Terumo Medical Corporation (Somerset, NJ)
- …the integrity of the SAP and Cloud Security Design and uphold the compliance and regulations setup in the application, database and infrastructure layer. This role ... Segregation of Duties and Critical Access risks to ensure compliance and mitigate security risks. This individual will design...and check the SAP and GCP Cloud configuration for Audit log and the retention policy associated with it… more
- Terumo Medical Corporation (Somerset, NJ)
- …executing clinical quality oversight activities across Terumo's clinical trials. This role ensures compliance with study protocols, of ISO 14155 / 13485 / 14971, 21 ... input to clinical teams to ensure data integrity, regulatory compliance , and patient safety throughout the study lifecycle. **Job Details/Responsibilities**… more
- Terumo Medical Corporation (Somerset, NJ)
- …the help of the Contracts Administrator. 6. Monitor and analyze contract compliance with Terumo contracts processes and policies. 7. Expertly understand TMCs ... national Group Purchasing Agreements to lead contractual administration obligations. 8. Identify necessary agreement templates and/or template modifications to meet… more
- Warner Music Group (New York, NY)
- …that retains the creative spirit of a nimble independent. **Job Title: Manager, Internal Audit ** **A little bit about our team:** The Warner Music Group Internal ... Audit vision is to provide high quality assurance and...+ Manage affiliate audits to assess financial, operational, and compliance processes and evaluate effectiveness of risk mitigation activities… more
- DWS Group (New York, NY)
- Job Description: Employer: DWS Group Title: AFC Compliance Officer (AFC & Compliance Officer) Location: New York City Job Code: #LI-LV2 #LI-02 About DWS: Today, ... can be part of an industry-leading firm with a global presence. You can lead ambitious opportunities and shape the future of investing. You can support our clients,… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …documentation. - Assist with month-end and year-end closing activities. - Ensure compliance with company policies, accounting standards, and audit requirements. ... options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …820, ISO 13485, EU MDR (2017/745), CMDR (SOR/98-282). + Demonstrated ability to lead QA medical device and combination products compliance and auditing ... Ensure all medical devices manufactured meet established specifications. + Ensure compliance of establish Quality Management System (QMS) and in compliance… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …outcomes with key stakeholders. + Case Auditing & Oversight: + Conduct routine audits Audit to assess quality, accuracy, and compliance with hub processes. + ... Ensure programs met and adhere to legal, regulatory and compliance standards. + Monitor hub process and free goods...ongoing relationship management for all programs. + Develop and lead training for sales and FRM team (ability to… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …maintaining and enhancing our **Quality Management System (QMS)** , ensuring compliance with global regulatory requirements, and preparing the site for inspections ... Review **Device History Records (DHRs)** and ensure documentation accuracy. + Lead and support **continuous improvement initiatives** for QMS processes. +… more
- Integra LifeSciences (Plainsboro, NJ)
- …processes as per outlined production schedules. All production is to be conducted in compliance with ISO 7 and ISO 5 Clean Rooms and with Good Manufacturing ... Directly supervises weekend first shift manufacturing cleanroom operators and lead operators. **ESSENTIAL DUTIES AND RESPONSIBILITIES** To perform this job… more
- SMBC (New York, NY)
- …and material non- compliance matters. + Assist the Regulatory Governance Team Lead in coordinating the intake and responses to regulatory inquiries and managing ... portfolio of benefits to its employees. **Role Description** The SMBC Compliance Advisory Function resides within Compliance Department Americas Division… more
