- Eisai, Inc (Orlando, FL)
- …region, including training, career evaluation, coaching, mentoring, performance management and talent review . Ensure compliance with regulatory and other ... technical platforms for recording of external interactions and for the collection, review , and dissemination of medical information.As a condition of employment… more
- Merck & Co. (Millsboro, DE)
- …Product Manufacturing, Pharmaceutical Manufacturing, Product Release, Quality Mindset, Regulatory Compliance , USDA Regulations, Vendor AuditsPreferred Skills: ... etc. - Performs GMP walk through inspections of assigned departments to ensure compliance with cGMPs and regulatory requirements Assistance with external audits… more
- Cipla (Hauppauge, NY)
- …that batch records and audit trails are readily accessible and properly formatted for regulatory review . Assist in the training of staff on proper documentation ... manufacturing processes, with a particular focus on audit trail review , data integrity, and overall GxP compliance ....all system actions are secure, traceable, and compliant with regulatory standard. Review of the batch records… more
- Insmed Incorporated (NJ)
- … medical expertise into the marketing strategies for the asset.Provide review of medical and commercial materials, including standard medical ... publications).Provide medical support in developing the strategy for Independent Medical Education in compliance with internal processes.Provide strategic … more
- Merck & Co. (Rahway, NJ)
- …Programs, FDA Regulations, IT Coordination, IT Operation, Pharmacovigilance, Policy Implementation, Regulatory Compliance , Regulatory Labeling, Regulatory ... will be on document production processes, including content authoring, review and finalization, and feed to the Submissions Assembly...industry experience, at least 6 of those in a regulatory and/or compliance area and experience with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees the management of ... implementation of obligations deriving from these contracts. Organize and conduct periodic review of contract quality and adherence PV Regulatory Intelligence:… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of NNI Patient Safety, with cross-functional working relationships within Intake and Triage, Medical Review , Submissions and Compliance , Global Safety, and ... closely patient safety leadership team members in Data Acquisition, Medical Review , and other case management leadership...workflows and performance metrics to ensure departmental KPIs and regulatory compliance are consistently met Audit &… more
- Cipla (Hauppauge, NY)
- …records Recommend process improvements to enhance the batch review process, reduce review time, and ensure better compliance . Address any issues or concerns ... to include a 401(k) savings plan and matching, health insurance - medical /dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off… more
- Eisai, Inc (Nutley, NJ)
- …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)
- …and establishes the oversight model for timely and quality delivery and regulatory compliance of outsourced activities.- Ensures inspection readiness of all ... data review and cleaning, database lock), to ensure data quality/integrity and regulatory compliance - Ensures that Data Management Plans are consistent and … more
