- 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)
- …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)
- …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
- 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …Innovation, Mentoring Staff, Operating Models, People Leadership, Pharmaceutical Development, Product Design, Product Development, Regulatory CMC, ... and scaling-up the formulation, device, and manufacturing process.- Driving drug product design from the benchtop to current Good Manufacturing Practice (cGMP)… 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)
- …stability assays for testing of clinical trial material and in support of product and process development.A strong team player with excellent oral and written ... transfer of assays. Plan assay optimization and documentation to meet program deadlines.Authoring and reviewing internal technical reports, sections of regulatory… 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
- 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
- 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
- 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 incumbant is responsible… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …customers. Our passion for helping people live better lives and our award-winning product pipeline can only be as effective as our ability to provide life-changing ... Reimbursement), HEOR, Marketing, Commercial Sales, Medical Affairs, and Legal & Compliance . External relationships include Customers as outlined in the Purpose of… more
- Merck & Co. (North Wales, PA)
- …subsidiaries in their HTA submissions.The incumbent is expected to contribute to product development and marketing strategies throughout the lifecycle to ensure that ... product value is defined and developed to achieve optimal...achieve / sustain reimbursement and market access for the program and indications under their responsibility.Critically assesses drivers and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It's ... and timely feedback towards performance expectations and goals Lead site training program Develop, coach, and build competencies of the Training team In conjunction… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …individuals in other NNI departments, including but not limited to Medical, Regulatory , Marketing, Sales, Commercial Operations, and Ethics, Compliance & ... as needed Advising on interactions with health care providers, patients, and payors in compliance with fraud and abuse laws such as the US Anti-Kickback Statute and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …NovoCare® Patient Support Programs. Management of relevant data sets include compliance and database information integrity, program tracking, metrics, analysis, ... and overall performance management Optimization, visualization, and automation of program performance, both retrospectively and prospectively Preparation of simple… more
