- DivIHN Integration Inc (Columbus, OH)
- …of medical adverse events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the ... processing adverse events for clinical or post-marketed products in compliance with applicable regulations, guidelines, researching, assessing and summarizing… more
- Catalent (Manassas, VA)
- … regulatory submissions, reviewing new and revised SOPs and guidance pertaining to Regulatory Affairs and regulatory compliance . Will prepare for and lead ... Associate Director, Regulatory Affairs Position Summary:... regulatory meetings, designing regulatory compliance strategy to ensure … more
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position Manage and oversee all assigned projects/products/processes. Assist the Director/ Associate Director in assuring Novo Nordisk compliance with ... agencies. Supervise designated personnel. Relationships Report to the Director/ Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory … more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Environmental, Health, and Safety (EHS) initiatives with a focus on environmental compliance and reporting. Priority reports include air permitting, Tier II & ... Hazardous Materials reporting, and wastewater discharge compliance . Develops and improves site policies, prepares and submits regulatory reports, independently… 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
- Merck & Co. (Durham, NC)
- …Control will be responsible for activities that support cGMP and regulatory compliance during method qualification/validation and routine product activities ... for the company; uses this knowledge in own workUnderstands and applies regulatory / compliance requirements relative to their roleInfluence, motivate, and… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …clinical research (patient safety, rights & wellbeing; data reliability; scientific integrity; regulatory & process compliance . Takes ownership to deliver upon ... approvals to assure quality of the documentation files and compliance with NN SOPs, relevant regulatory requirements...files and compliance with NN SOPs, relevant regulatory requirements and ICH and GCP guidelines Provides support… more
- Eisai, Inc (Nutley, NJ)
- …customer journeys and strategies across target audiences as well as ensure regulatory /legal and compliance requirements are met.This role requires strong ... 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… more
- Novo Nordisk Inc. (San Antonio, TX)
- …research (patient safety, rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance ) for monitoring and site management ... 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)
- …vendor invoices and monthly billing packages.Manage/support health literacy and legal/ regulatory / compliance reviews.Serve as liaison with patient advocacy group ... of carefully designed clinical trials is critical to drug development.The Associate Director, Clinical Trials Communications role within our Research & Development… more
- Merck & Co. (North Wales, PA)
- …success in the assurance of deliverable quality and process compliance .Ability to anticipate stakeholder and regulatory requirements.Preferred Experience ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… 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
- Catalent (San Diego, CA)
- …wide variety of activities pertaining to supporting, maintaining, and assuring compliance with quality systems requirements and applicable regulatory ... Quality Assurance Associate II - Manufacturing Catalent Pharma Solutions in...a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the CMR training strategy Ensuring CMR employees receive training on regulatory compliance , quality standards, GxP requirements and industry-specific guidelines ... 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… 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. (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
- Merck & Co. (Rahway, NJ)
- …serves as Quality spokesperson, on a variety of Quality or compliance -related issues.Interprets complex regulatory requirements for various audiences, including ... a matrix/management environment.Lead the resolution of business practice, Quality and/ or compliance issues of broad scope and highest level of complexity. on… more
