- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to data governance to ensure data integrity, quality, consistency, and compliance with regulatory requirements.Define data governance principles, policies, and ... centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of...standards specific to GRA, in line with corporate data policy.Collaborate with cross-functional stakeholders (incl. RD… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …major programs or initiatives, and may function in a project leadership role Regulatory compliance : Ensures compliance with all Federal regulations, ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...safety data reconciliation and QC activities from suppliers and corporate partners to ensure compliance with SDEA… 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 ... implementation of Veeva Vault, IDMP, EU CTR, and other regulatory initiatives. Work with stakeholders to gather requirements and...of Core Data Sheets and USPIs/ PPIs, facilitation of corporate review and approval activities for CDS and regional… more
- Merck & Co. (Rahway, NJ)
- …of requirements, ensuring alignment with business objectives . - Knowledge of corporate compliance business processes ( eg , Anti-Bribery & Corruption) ... job families, such as Information Architecture and Software Engineering. - Ensures compliance applications and platforms adhere to relevant regulatory and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …assess impact and oversee the company's compliance with new and changed regulatory obligations related to Corporate Compliance . Informs management of ... make a difference? The Position This position supports the Corporate Compliance & Privacy Officer in setting...licensure (eg, OR rep licensure), NNI government agreements (eg Corporate Integrity Agreement (CIA)) regulatory requirements (eg… more
- Catalent (Philadelphia, PA)
- …(as required). Audit for compliance as pertains to Catalent SOPs, regulatory , and customer requirementsSupport Corporate and local Quality policies and ... material management of materials at Catalent-Philadelphia. Assist in the enforcement of regulatory compliance through state, FDA, DEA, CDC, and USDA… more
- Catalent (Harman, WV)
- …the Quality Management Systems (QMS) to ensure the site is compliant with regulatory , Corporate , and customer requirements. They are responsible for establishing ... with regulatory requirements/expectations.Interface with all other departments to ensure compliance with cGMP.Monitor site compliance to FDA, EU and all… more
- Catalent (Harman, WV)
- …direct interaction, responsiveness and accountability.Insures compliance with all corporate and applicable regulatory SOP and cGMP guidelines.Manages ... to ensure a process of business recovery of cost changes as appropriate.Maintain compliance with all regulatory requirements and ethical standards related to… more
- Merck & Co. (Millsboro, DE)
- …capital budgets.Establish and maintain departmental policies and procedures. Ensure compliance with governmental regulations, and corporate /site policies ... and unregulated species including chickens, turkeys, dogs, cats, rabbits, and rodents.Assure compliance with all federal and state regulatory requirements for… 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 ... Brand team, IT, analytics/market research, sales leaders, sales training, legal, regulatory and complianceExperience working with and directing creative and media… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with many stakeholders in the data area including functional representatives, corporate representative, IT, privacy, legal, compliance , IT security, ... community and set of practices to manage data as corporate assets. Communicate and help the community manage good...from multiple functions, domain experts in privacy, security, and compliance and technology and IT owners from the digital… more
- Catalent (St. Petersburg, FL)
- …ensuring the site is following cGMP guidelines, adherence to Catalent Corporate Quality Policies and applicable Catalent Pharma Solutions quality standards across ... Operations, Customer Service, Validation, Quality Control, etc.) to ensure continued compliance for the area/site. Will provide directional support and as required,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Procedures (SOPs). Ensures quality control activities are aligned with industry, regulatory and corporate practice. Exercise judgment within generally defined ... day-to-day QC Microbiology activities for routine in-process and product testing ensuring compliance , accuracy and timeliness of testing processes in compliance … more
- Novo Nordisk Inc. (Boulder, CO)
- …validation/revalidation assignments Review & approve documents in accordance with local, corporate & regulatory regulations Collaborate, review & approve IQ, ... analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder,… more
- BioAgilytix (Durham, NC)
- …cell work, gene therapy and more.We are looking for candidates who have practical regulatory experience with bioanalytical data in a corporate GxP setting. This ... data, you will ensure data integrity standards are met across various equipment, regulatory settings, and workflows. You are the bridge between the lab and the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …This position will interact with enterprise consumer brand teams, Global Marketing, Corporate Communications, Market Access, Medical, Sales, Legal, Compliance & ... the regulatory and legal aspects of digital marketing. Ensuring compliance with legal and defined quality requirements Identifies opportunities to enhance… more
- Merck & Co. (Durham, NC)
- …of process control, data collection techniques, and troubleshooting in compliance with SDLC, GMP, safety, and environmental regulations.- Actively support, ... approve automation documents, preventive maintenance, and SOPs to ensure compliance with Good Manufacturing Practices and safety.Leads investigations of automation… more
- Aequor (Hicksville, OH)
- …etc.). Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and ... Departmental, Plant, and Corporate quality and Behavioral Based Safety (BBS) goals.Key Performance Indicators (knowledge, skills, and abilities expected of an… more
- Eisai, Inc (Nutley, NJ)
- …digital initiatives within budget and adhering to digital governance, legal, compliance and regulatory standards. Requirements Bachelors in science or ... functional partners including digital vendors.Thorough understanding of the pharmaceutical corporate environment and experience partnering with cross functional teams… more
- Lundbeck (White Plains, NY)
- …patients including the full range of treatment options available. Pharmaceutical Environment/ Compliance - Ability to apply knowledge of pharmaceutical and ... regulatory environment, including Lundbeck policies and procedures and FDA...healthcare economy and industry practices. Accountability and adherence to corporate , FDA, and PDMA guidelines.REQUIRED EDUCATION, EXPERIENCE and SKILLS:… more
