- Daiichi Sankyo, Inc. (Bernards, NJ)
- …years with focus on pharmaceutical regulatory affairs, incl. familiarity with regulatory compliance frameworks (eg, ICH, FDA, EMA) (Required)2 or more years ... on a consistent basis and identifying areas of potential non- compliance or operational risks.Responsibilities:Maintain regulatory procedural documentation, in… more
- Novo Nordisk Inc. (Boulder, CO)
- …Valuation Directly responsible for taking corrective action when there are issues with non- compliance Conducts monthly review of exports reported through AES to ... new medicines for patients. The Position The Specialist, Logistics & Global Trade Compliance is responsible for enforcing company-wide compliance with US Customs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …data quality and proactive detection and resolution of issues.External Engagement:Continuously review compliance metrics trends from regulators/ industry experts ... pharmacy, REMS, co-partners and affiliates. Liaise with Audit and Compliance team to ensure that Global Medical ...QMS framework (ie, Quality Management Review , Quality Review Board) across the global medical affairs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and guidance to RD PV QA on quality assurance practices and regulatory compliance .Keep abreast of evolving regulations and industry standards concerning ... and Quality OversightPlay a key role in ensuring compliance with regulatory requirements while driving innovative...with IT to align system development with business and regulatory expectations. Review systems for affiliate companies… more
- Aequor (Thousand Oaks, CA)
- …of role and responsibility Knowledge and skills: Knowledge of case management and medical review SOPs and regulatory requirements for Pharmacovigilance ... Remote maximum bill rate is /hour**Job description: Execute the medical review of ICSRs (narratives, coding, expectedness,...expected terms in the auto label tool Monitor the compliance of autolabel tool updates (if applicable) Support and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to each product safety team in critical areas such as individual case medical review , risk management, aggregate safety reports, and translational medical ... reports)Proven experience leading safety physicians and scientists in individual case medical review , aggregate reporting, risk management, and/or translational… more
- Merck & Co. (Durham, NC)
- …Quality Assurance (QA), Quality Auditing, Quality Management Standards, Quality Standards, Regulatory Compliance {+ 5 more}-Preferred Skills:Job Posting End ... of tasks required to release batches such as DOM/SLED Review , QN and CR review , testing ...release SME (Subject Matter Expert) to support internal and regulatory audits.Support and lead department related initiatives associated with… more
- Merck & Co. (Durham, NC)
- …Reliability, and Lifecycle Management). Lead Periodic Business and Operations Review Meetings (with External Partner).-- Compliance :-Achieve compliance ... - Knowledge of lean principles, equipment design, and preventative maintenance.- Regulatory - Global regulations and compliance requirements governing… more
- Merck & Co. (Rahway, NJ)
- …state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and ... investigators.-Is responsible for planning and ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies.Participates with management in… more
- Merck & Co. (Durham, NC)
- …and implementation of preventative and predictive maintenance programs to assure compliance with quality, regulatory , and reliability requirements and ... a focus on safety, current Good Manufacturing Practices (cGMP) compliance and efficiency.Define requirements and specifications for equipment.Manage the… more
- Eisai, Inc (Philadelphia, PA)
- …to work independently and not require close supervision while adhering to compliance / regulatory policies. Interest in leading and participating in projects while ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...members without a direct reporting relationship Research Support Facilitate review and follow up of submitted Investigator-Initiated Studies (IISs)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Safety (ISS) for oncology submission compounds, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review … more
- Merck & Co. (Durham, NC)
- …Right First-Time culture by reducing waste and constantly driving continuous improvement-- Review and approve compliance documents, as per procedures or ... a quality product at a competitive cost consistent with our Company, Regulatory Agency, and State and Local code requirements for quality, good manufacturing… more
- Eisai, Inc (Exton, PA)
- …activities and deliverables.Minimum of 3 years work experience with pharmaceutical regulatory compliance and global regulations for computerized systems ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...and external computing platforms and solutions.Conducts audits and periodic review as assigned for quality assurance compliance … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Provide vendor comparisons and award qualified vendors.Provide SME support for regulatory inspections and regulatory filings.Author/ Review /Approve documents ... EPA, OSHA, and the FDA. Monitors and ensures company compliance with regulatory standards.Excellent organizational and communication skills.#Li-JK2#Li-HybridThe… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and establishes the oversight model for timely and quality delivery and regulatory compliance of outsourced activities.Ensures inspection readiness of all data ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Eisai, Inc (Raleigh, NC)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... SCM Unit will lead a cross-functional team driving excellence in Import/Export Compliance , Logistics, and Supply Chain support while interfacing closely with other… more
- Novo Nordisk Inc. (Durham, NC)
- …standards within the assigned process Provide coaching to Site regarding quality & compliance related activities Facilitate sharing of regulatory & compliance ... Department For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes &… more
- Merck & Co. (North Wales, PA)
- …state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and ... as a reviewer for the cross-functional translational medicine document review committee.Support due diligence in-licensing projects in the translational medicine… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …level analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review study submission data ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
