- Merck & Co. (Rahway, NJ)
- …Medical Devices, Mentoring Staff, Ophthalmology, Pathophysiology, People Leadership, Physiology, Program Management, Regulatory Affairs Compliance {+ ... and effective implementation and oversight model to maintain best in industry regulatory compliance .The Vice President Regulatory Affairs, General Medicine… more
- Merck & Co. (Rahway, NJ)
- … product manufacturing processes to GMP production facilities.Experience authoring regulatory filings, and demonstrated working knowledge of FDA, ICH, and other ... Job DescriptionPrincipal Scientist - Mixed Modalities, Sterile Product DevelopmentThe Mixed Modalities team within Sterile Product Development is responsible for… more
- Merck & Co. (Rahway, NJ)
- …participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... Immunochemistry, People Leadership, Pharmaceutical Development, Pharmaceutical Formulations, Pharmaceutical Sciences, Product Development, Regulatory CMC, Statistical Design of… more
- Merck & Co. (Rahway, NJ)
- …Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance , Risk Management, Sourcing and Procurement, ... key partner organizations ( as a lead GCS Planning program representative ) such as clinical development, regulatory...timelines for bulk manufacturing needs and release of drug product across assigned program (s) . - Works… more
- Merck & Co. (Rahway, NJ)
- …and broad working knowledge of pharmaceutical vaccine/biologic/small molecule drug product and process development including regulatory submission and ... Engineering, Intellectual Curiosity, Pharmaceutical Development, Product Development, Product Lifecycle Management (PLM), Project Management, Regulatory … more
- Merck & Co. (Rahway, NJ)
- …products from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This position ... controls approach within Device Development and with external suppliers.Understand and apply regulatory / compliance requirements relative to design controls and… more
- Merck & Co. (South San Francisco, CA)
- ….Stay up to date with industry trends, technology advancements, and regulatory requirements for diagnostic assays.Drive diagnostic product innovation and ... stakeholders to ensure alignment with clinical development timelines and regulatory requirements. Most importantly, the role requires overseeing CDx development,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Partner where requested by management Develops comprehensive, relevant resources (eg training program , FAQs) to enable compliance with QMS process requirements ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...COE Develops and executes regular surveillance, follow-up, and reporting program to ensure process compliance within the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …standards and processes as applicable Develops comprehensive, relevant resources (eg training program , FAQs) to enable compliance with quality control process ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...provides input to support regular surveillance, follow-up, and reporting program to ensure process compliance within the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …external health authority regulations Develops comprehensive, relevant resources (eg training program , FAQs) to enable compliance with Deviation process ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...applicable Develops and executes regular surveillance, follow-up, and reporting program to ensure process compliance within the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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 ... are operating the lines and handling the material/equipment according to product specifications, reviewing batch paperwork, performing line clearances, setting up… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… 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 ... line and monitors for defects. Inspects filled container or package to ensure product is according to specifications. May weigh finished products to detect missing… more
- Insmed Incorporated (San Diego, CA)
- …transfers and mentoring junior staff. Maintaining laboratory equipment, ensuring safety and regulatory compliance , and supporting audits are also part of the ... Unit (internal or external QC). May act as a program lead on a PDT as required by the...method transfer and validation as needed. Support the biotechnology product lifecycle, from early-stage research through commercial launch. Involves… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and manage relationships with contractors to ensure quality of work and compliance with all company policies and regulatory guidelinesHelps improve metric ... PLCs, VFDs and electrical practices generally attained through hands-on experience, cGMP compliance , EHS and regulatory standards (eg EPA, OSHA and… more
- Merck & Co. (North Wales, PA)
- …to obtain in-depth understanding of country specific HTA/reimbursement needs for the product and gain input on research design and implementation of retrospective ... epidemiological studies and economic modeling.The Director also works closely with Product Development Teams, Franchise Teams, Regional Product Directors,… more
- Merck & Co. (Rahway, NJ)
- …upstream and downstream processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and commercial ... development, tech transfer of clinical or/and commercial processes, and pertinent regulatory filings. The incumbent will be responsible for recruiting, appraising,… more
- Eisai, Inc (Nutley, NJ)
- …practices that can help simplify the patient journeyIdentify and ensure training ( product , disease state and compliance training) for promotional speakers and ... issuesOffer feedback on nominating new speakers when applicableCoordinate / facilitate new product and annual compliance trainingWork with Marketing Team for… more
- AUROBINDO (Durham, NC)
- …of companies that has a long history of excelling in generic pharmaceutical product development and manufacturing. Aurolife has a 10 year history of extraordinary ... with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a… more
