- Merck & Co. (Rahway, NJ)
- … Regulatory Affairs Compliance , Regulatory Compliance , Regulatory Labeling, Regulatory Operations , Regulatory Submissions, Strategic ... full-time Business System Associate for the Labeling Operations area within the GRACS Regulatory Innovation...design improvement opportunities within the Support Model to reduce compliance risk and increase efficiency for the Support Team… more
- Merck & Co. (Upper Gwynedd, PA)
- …(BLA), Electronic Common Technical Document (eCTD), Immunochemistry, International Regulatory Compliance , Microbiology, Molecular Microbiology, Pharmaceutical ... Job DescriptionGRACS CMC - Associate Principal Scientist, CMC, R4 - Pharm Pre-approval...Process Development, Regulatory Affairs Compliance , Regulatory Affairs Management, Regulatory … more
- Eisai, Inc (Exton, PA)
- …Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of Biologics Operations maintains knowledge of established ... your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and...documentation, manufacture of DS/ADI materials, and suite change-over ensuring compliance to relevant regulations. The Associate Director… more
- Merck & Co. (Durham, NC)
- …excellence in Compliance , Supply, Continuous Improvement, and Cost Management.--The Associate Director, External Manufacturing Operations will also assist in ... contact for all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a… more
- Insmed Incorporated (San Diego, CA)
- …program lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to ... transfers and mentoring junior staff. Maintaining laboratory equipment, ensuring safety and regulatory compliance , and supporting audits are also part of the… more
- Merck & Co. (Rahway, NJ)
- …Experience with sterile GMP facility startup.Knowledge of Investigational drug regulatory requirements.Understanding of Clinical Supply Chain Operations .Current ... in Rahway, New Jersey.The Sterile Process Engineer role at the Associate Director level will leverage the individual's leadership, technical, and communication… more
- Merck & Co. (Rahway, NJ)
- …matters.Review process change requests and deviation reports while ensuring regulatory compliance .Education and Minimum Requirements:Bachelor's degree in ... Relationships, Lean Manufacturing, Manufacturing Processes, Manufacturing Support, Pharmaceutical Manufacturing, Regulatory Compliance , Root Cause Analysis (RCA), Stakeholder… more
- Aequor (West Greenwich, RI)
- …1. Perform sample collection and sample handling to support GMP operations and Environmental/Water monitoring. 2. Perform testing and possible data review ... as necessary. 6. Perform general laboratory housekeeping activities. 7. Maintain training compliance and proficiency. 8. At all times, comply with safety guidelines,… more
- Twist BioScience (South San Francisco, CA)
- …that all products processed, packaged, stored, and distributed are manufactured in compliance with all Regulatory , Customer, and Twist requirements. In this ... The QC Associate II will be responsible for the implementation...the production laboratory. He/she will work closely with the operations team to monitor the quality of Twist DNA… more
- Eisai, Inc (Nutley, NJ)
- …exchange.Maintain scientific credibility and ensure operational excellence (20%) Ensure compliance with regulatory and other ethical guidelines relevant ... your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education...independent medical education and symposia.Work with strategic planning & operations to manage the Global MSL projects budget by… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …teams, manage performance, and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan,… more
- Merck & Co. (Rahway, NJ)
- …Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance , Risk Management, Sourcing and Procurement, ... GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate...clinical supply planning and incorporate them into the team's operations . - Focus on Customers & Patients. - Make… more
- Merck & Co. (Durham, NC)
- …Production Operations , Production Support, Project Management, Regulatory Compliance , Teamwork, Training and Development-Preferred Skills:Leadership, ... questionnaire, blood test, chest x-ray Position Responsibilities:This role reports to an Operations Associate Director and supports the product transfer for a… more
- Merck & Co. (North Wales, PA)
- …with partners, vendors, and vendor management team . Review and provide clinical operations input into relevant clinical documents such as the protocol and other ... engagements. This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability to manage competing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams.Responsibilities: Study Strategy:… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations , Non-clinical, Clinical, and other functional areasExperience… more
- Aequor (Thousand Oaks, CA)
- …new technologies and ensure smooth integration into new and/or modified processes Regulatory Compliance and Quality Assurance: Ensure all data management ... and reduce hand offs. Collaborate with cross-functional teams (clinical operations , site management, biostatistics, stats programming, TA) to optimize trial… 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 ... breaks.Job Purpose Able to perform various inspecting, labelling and packaging operations . Tends machines that perform one or more packaging functions, such… more
- RWJBarnabas Health (Somerset, NJ)
- …health/business administration, regulatory compliance , accreditation or licensure associate , business development or operations manager. + Minimum three ... Regulatory Planning Manager (Hybrid) - Somerset, NJReq #:0000170498...and interpretations to assist in program design, development and compliance . Manager prepares, as necessary, applications and plans, including… more
- Humana (Montgomery, AL)
- …the candidate will be required to work in either Central or Eastern Time. Associate Director, Regulatory Intake Compliance is responsible for enterprise-wide ... value and reduces compliance risk exposure for the organization. The Associate Director, Regulatory Intake Compliance will be responsible for/to:… more
Related Job Searches:
Associate,
Compliance,
Compliance Operations,
Compliance Operations Associate,
Operations,
Operations Associate,
Regulatory,
Regulatory Compliance