- Eisai, Inc (NJ)
- …this is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately 3-4 ... or related industry OR equivalent combination of education and experienceExperience writing /reviewing clinical regulatory documents and submissions for own area… more
- Nesco Resource (Dublin, OH)
- …teams. This role is an individual contributor that reports to the Sr Manager of Finance and Accounting Responsibilities: Ensure accurate accounting of assigned books ... of monthly reconciliations of assigned balance sheet accounts Government and other regulatory body reporting Ensure best practices in business processes and related… more
- Merck & Co. (Durham, NC)
- …shifts and teamsSubject Matter expert for LOTO and permit writing for maintenance activities, Safety Management Information Systems (SMIS) transactionsKnowledge ... of inclusion, feedback and empowerment.Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry.Ability to read… more
- Eisai, Inc (Nutley, NJ)
- …and assures compliance with standard operating procedures, compliance with regulatory standards and guidelines, and compliance with operating agreements with ... and summary reports for submission to the FDA and International Regulatory authorities.Interface with other Eisai Departments and affiliates for dissemination of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …products reach the people who need them most. The Position As the Manager , Content Operations, you will support Novo Nordisk's strong commitment to its Omni-channel ... operational viability of the product, and anticipating future business needs. The Manager will be responsible for providing content feasibility insights to support… more
- Aequor (NJ)
- 100 % remote Manager prefers local candidates (will consider non local candidates as well) Required bachelor's degree Must Haves: Phase 1 to 4 clinical trial ... studies during phases 1-4. The individual must partner closely with clinical, regulatory , quality and production associates to ensure timely delivery of supplies to… more
- Novo Nordisk Inc. (Durham, NC)
- …the world, driving the stability portfolio for all products, and writing and maintaining regulatory documentation. Relationships Director. Essential Functions ... Lead, drive & coach teams to ensure a high performing collaborative team environment, to include providing feedback, structure & accountability to continuously improve team engagement & performance Drive Mdev LCM and QA requirements at the site ensuring a high… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical ... at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight:… more
- DivIHN Integration Inc (Atlanta, GA)
- …develops high quality clinical documents ensuring scientific excellence and regulatory compliance. The development process includes writing , interpreting, ... excellent writing skills. 5 years of on-the-job experience in scientific/medical writing (eg, clinical trial and regulatory documents) preferred but not… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Releases product based on Quality Assurance record review and approval by QA Manager Performs regular internal audits of NNUSBPI facilities as a lead auditor Works ... Reviews and assesses Corrective and Preventive Action Reports Participates in Regulatory Inspections Other duties as assigned Performs all job duties and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …(SOPs). Ensures quality control activities are aligned with industry, regulatory and corporate practice. Exercise judgment within generally defined practices ... assistance is available for this role. Relationships Reports to: QC Manager Number of subordinates with direct/indirect referral: 5-10 Essential Functions Oversee… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Releases product based on Quality Assurance record review and approval by Manager , Quality Assurance Review and assess Corrective and Preventive Actions Reviews and ... performing and reporting internal and vendor audits as scheduled Participate in Regulatory Inspections Performs all job duties and responsibilities in a compliant… 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, ... and GalXC+ platform products. Relationships This position reports to the Manager , Analytical Development as an individual contributor. Daily interaction with other… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …role is eligible for relocation assistance. Relationships Reports to: Quality Control Manager Number of subordinates with direct/indirect referral: none, this is an ... ongoing supervision and development opportunities Support the submission of worldwide regulatory filings Performs all job duties and responsibilities in a compliant… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.- Drug Development Strategy: Provides input to ... at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.- CRO / Vendor… more
- Jacobs (Scoville, ND)
- Full-time Quality Assurance (QA) Manager of a multi-billion-dollar nuclear facility construction project, taking day-to-day direction from the Project Manager , ... of the QA program. Ensure compliance with customer/client standards and government regulatory requirements. Work location is near the Naval Reactors Facility at… more
- Axelon Services Corporation (Atlanta, GA)
- …studies during phases 1-4. The individual must partner closely with clinical, regulatory , quality and production associates to ensure timely delivery of supplies to ... ( GSMM ), Project Management, Client Affiliates, Medical Affairs (MA), Regulatory , CMC, QA, Packaging Vendors, CRO's, IRT Organizations, and Global Clinical… more
- Lennar Homes (Nashville, TN)
- … Manager (s), Division and Community Safety Coordinators as needed, regulatory agencies and other division associates. Responsibilities Ensure the division's ... Environmental Manager . Be available to conduct walk through during Regulatory stormwater and OSHA inspections and document inspections. Participate in the… more
- DCS Corp (Bedford, MA)
- DCS Corp has an exciting opportunity for a Journeyman Program Manager providing support to the Air Force Life Cycle Management Center (AFLCMC/HBD), Theater Battle ... and development efforts. Provide program level acquisition support to the Program Manager and Integrated Product Team Leads by helping guide successful program… more
- Lennar Homes (Raleigh, NC)
- …air quality, and wetlands, modules. Regularly interact with the Regional Environmental Manager (REM), Director of Construction, regulatory agencies, and division ... and Community SWPPP's with the DOC and Regional Environmental Manager . Strive to reduce liability of regulatory ...storm water run-off and air quality. Must have strong writing and organizational skills; Detail oriented. High degree of… more
