- Aequor (Newbury Park, CA)
- …instructions/guides, since we work in a framework based on rules/ compliance . Education background preferred for this role: Science/Technology-based degrees are ... requires resourcefulness and critical thinking skills.) Job Title: Sr. Associate - Records Information Management & Systems (RIMS)Job DescriptionKey responsibilities… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe role is accountable for performance and compliance for assigned protocols and sites in a country.Under the oversight of the CRA manager or CRD, ... the person ensures compliance of study conduct with ICH/GCP and country regulations,...appropriately in a timely manner.Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study… more
- American Honda Motor Co Inc (Marysville, OH)
- …America. AHM Audit also promotes self reliance within NA operations and ensures regulatory compliance while maintaining competitive costs but with the highest ... assist and support the North American Regional Operating Board (NAROB) and senior executives across North America to strengthen risk management, internal controls,… 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
- 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
- Catalent (Harman, WV)
- …to ensure a process of business recovery of cost changes as appropriate.Maintain compliance with all regulatory requirements and ethical standards related to ... Senior Director, Supply Chain Position Summary: The ...sustains customer relationships through direct interaction, responsiveness and accountability.Insures compliance with all corporate and applicable regulatory … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …assets are easily accessible and properly utilized. Relationships Reports to the Associate Director of Content Management; Provides direct support to the Digital ... multiple NNI internal functions such as Brand Managers, Omnichannel teams, IT, Regulatory and Commercial Insights & Analytic, as well as external operational vendors… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Specialist, Manufacturing Automation The Senior Specialist Manufacturing Automation person is primarily responsible ... to improve manufacturing performance, and maintaining the automation systems in compliance with cGMPs. The Manufacturing Automation Sr. Specialist must actively… more
- Eisai, Inc (Nutley, NJ)
- …to the Senior Director, Omnichannel Marketing (HCP and Patient). The associate director will also partner closely with key internal partners to deliver ... customer journeys and strategies across target audiences as well as ensure regulatory /legal and compliance requirements are met.This role requires strong… 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...Clinical Trial sites. Accountable for overall performance management of Senior Supply team, who contribute to the planning, execution… more
- Eisai, Inc (NJ)
- …this is your profile, we want to hear from you. Job Summary The Associate Director, Clinical Outsourcing, will oversee and lead and support activities related to the ... and functional service providers for Eisai's R&D functions. This role will ensure compliance with key processes and manage the outsourcing team. The ideal individual… more
- Novo Nordisk Inc. (Boulder, CO)
- …analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, ... cost & timely completion of all validation deliverables. Relationships Associate Director. Essential Functions Perform, review & approve validation/revalidation.… 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
- Insmed Incorporated (Bridgewater, NJ)
- …of Record and media agencyWork closely with cross-functional partners including Legal, Regulatory , Compliance , and Medical Affairs, to align and compliantly ... in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director, HCP Marketing will be a key member...of our culture. This position will report to the Senior Director, HCP and Payer Lead. This position does… 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. (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
- George Washington University (Washington, DC)
- …Institute School of Public Health at the George Washington University is seeking a Senior Research Associate to assist the department in conducting an NIH-funded ... at the University of Virginia and numerous clinical providers in Washington, DC. The Senior Research Associate will lead the day-to-day management of the study… more
- Fidelity TalentSource LLC (Boston, MA)
- …exams completedKnowledge of benefit program design, legislative, account and regulatory requirements (IRS/DOL/FAS/PBGC/ERISA/409A/PPA) The Skills You Bring You have ... cost and benefit design studies, non-discrimination testing, benefit statements and compliance Training and assisting Analysts to ensure the continued development of… more
- Merck & Co. (Rahway, NJ)
- …safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director, is a subject matter expert in CDISC Controlled ... associated reference data to data collection and transformation specifications in compliance with Health Authority regulations and guidance and company best… more
