- Aequor (Thousand Oaks, CA)
- …Functional areas, internal and external to GRAAS, local offices, external partners, and regulatory authorities. This will be a 100% remote role. The hiring manager ... instructions/guides, since we work in a framework based on rules/ compliance . Education background preferred for this role: Science/Technology-based degrees are… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …based on potential impact on product quality, patient safety, and regulatory compliance . Address recurring deviations and health authorities' observations ... in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of… more
- Aequor (Thousand Oaks, CA)
- …submission/documents experience Or Bachelor's degree and 5 years of Writing Regulatory or scientific submission/documents experience Or Associate 's degree and ... editing and of related regulatory guidance (eg, ICH) governing regulatory submission documents and industry compliance Strong written/oral communication… more
- Merck & Co. (Rahway, NJ)
- …key Workplace Privacy policies, specifications, and processes as the privacy regulatory landscape evolves.The Global Workplace Privacy Program manager is a perfect ... enterprise Privacy Impact Assessment, ensuring the assessment stays ahead of regulatory developments and ensures workplace-related personal data activities are … more
- Merck & Co. (North Wales, PA)
- …teams in order to build partnerships and trust with Commercial Legal, Compliance , Privacy and Regulatory colleagues to effectively alleviate concerns and ... Hybrid work model (combination of in-office and work from home abilities).The- Associate Director, Digital & Omnichannel Innovation for US Oncology-focuses on digital… more
- Merck & Co. (Millsboro, DE)
- …and unregulated species including chickens, turkeys, dogs, cats, rabbits, and rodents.Assure compliance with all federal and state regulatory requirements for ... Delaware seeks to add an Attending Veterinarian in the role of Associate Director.This position will have overall responsibility for oversight and administration of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ROI, KPI, financial milestones and related payment schedules) Advanced knowledge of regulatory and compliance requirements for clinical research, ICH GCP ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...appropriate changes to ensure trial conduct is completed in compliance and meets Novo Nordisk's business standards Risk management:… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …leveraging competencies, tools, and technology. Maintains responsibility for quality, performance, regulatory compliance , and patient safety related to managing ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Merck & Co. (Rahway, NJ)
- …and financial acumenOutstanding collaborative skillsKnowledge of the pharmaceutical industry compliance and regulatory environment. Position Qualifications : ... Job DescriptionPosition Description: Regional Associate Director New Segments Development LatAm Main Objective:...New Segments Development LatAm Main Objective: As the Regional Associate Director, your primary responsibility will be to identify,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …marketing, market access, commercial insights and analytics, sales, medical/CMR, legal, compliance , and regulatory . Other internal relationships include Public ... Field Access, and Payer), Brand Marketing, Training, Market Access, Trade, Legal, Compliance , Finance, HEOR, and Market Research. The position has high exposure to… 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
- Merck & Co. (Rahway, NJ)
- …(SMP) to drive assurance of supply, quality, service, cost, innovation, and regulatory compliance within assigned categories resulting in sourcing plans that ... Job DescriptionPosition Description: Associate Director, Marketing Operations Procurement (Hybrid) Working as part of a global & dynamic team, this position is… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good Clinical ... against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile… more
- Merck & Co. (North Wales, PA)
- …Agile Team on strategic priorities and campaign maintenance.Collaborate with Legal, Regulatory , Compliance , and the Customer Agile Team during ... Job DescriptionJoin our organization as a highly motivated Associate Director and Product Marketing Owner for heart failure and be part of the newly developed… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to regulatory process optimizations on relevant topics.Responsibilities- Supports CMC regulatory compliance activities for portfolio biologics to meet US, ... research areas centered around rare diseases and immune disorders.Summary The Associate Director, RACMC Portfolio Products, will be responsible for regulatory… more
- Merck & Co. (Rahway, NJ)
- …Administration, Facilities and Security. The Large Molecule Operations Sourcing Associate Director in Global Operations Sourcing Procurement supports the sourcing ... key leaders and stakeholders, namely Commercialization, External Manufacturing, Quality, Regulatory , Supply Chain, Finance, Legal, Shared Business Services, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Environmental, Health, and Safety (EHS) initiatives with a focus on environmental compliance and reporting. Develops and improves site policies, prepares and submits ... regulatory reports, independently track recurring regulatory reports...as an emergency response coordinator. Monitors and ensures site compliance with local, state, and federal standards for occupational… more
- Aequor (Athens, GA)
- …plan creation oversight, verifying that changes adhere to local SOPs and regulatory compliance and ensuring communication/escalation of potential issues of ... timely documentation. Provides guidance to MFG, E&T, and/or QC to ensure compliance with all applicable regulations and assists in resolution of issues identified.… more
