- Tris Pharma (Monmouth Junction, NJ)
- …Senior Generics Leadership and team members, the incumbent follows proper protocols and compliance with regulatory and company requirements to handle and support ... our Monmouth Junction, NJ facility for a Sales Support Associate . The Sales Support Associate supports and...and reports for the Generics team to ensure customer compliance , performance to budget and optimized sales efforts for… 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- …- Basic Functions & Responsibility As a member of the Device Quality & Regulatory QMS group, the Associate Director will participate in and/or lead various ... and tackle challenges, balancing effective operations with transformative initiatives.- The Associate Director, Quality System & Compliance will support to… more
- Merck & Co. (Rahway, NJ)
- …Employee Training, Environmental Health and Safety (EHS) Management, Environmental Regulatory Compliance , General Safety, Health Safety, Health Safety ... company's Industrial Hygiene standards and technical guidelines to ensure compliance and reduction in workplace Industrial Hygiene risks.Lead global continuous… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionContainer Closure Integrity Testing Lead, Associate Principal Scientist, Analytical Research & Development The Analytical Research and Development ... group has an opening for an Associate Principal Scientist based in Rahway, NJ. Join us...external sites and be familiar with current industry and regulatory requirements on CCIT.This position will involve method troubleshooting,… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... of decision-making at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate … more
- Merck & Co. (Rahway, NJ)
- …Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical Development ... pharmacology and pharmacometrics of oncology drugs from post-PCC to registration. - Associate Directors are emerging leaders in the field of quantitative drug… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: The Associate Director, Laboratory Data Management is accountable for the end-to-end delivery ... delivery of laboratory data for clinical trials, clinical development, and regulatory submissions. This position develops and proposes strategies for laboratory data… more
- Merck & Co. (Rahway, NJ)
- …in context of broader process and product development.- Working knowledge of regulatory guidance and quality standards, with experience authoring and reviewing ... regulatory submissions and responses (biologics license application submission) and...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Rahway, NJ)
- …for establishing a strong business partnership and ensuring excellence in Compliance , Supply, Continuous Improvement, and Cost Management.--The Associate ... - Knowledge of lean principles, equipment design, and preventative maintenance.- Regulatory - Global regulations and compliance requirements governing… 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 ... Support, Occupational Health and Safety Management, Pharmaceutical Manufacturing, Regulations, Regulatory Compliance {+ 5 more}-Preferred Skills:Job Posting End… more
- Merck & Co. (Rahway, NJ)
- …West Point, PA / Rahway, NJ is seeking a curious and collaborative Associate Director to support our rapidly expanding cardiometabolic and ophthalmology pipelines. - ... As an Associate Director, you will represent QP2 on cr o...vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/ Associate Director, has primary responsibility for ... reimbursement and market access, and provide input into clinical, regulatory , payer/access, marketing and evidence generation strategy and programsIn collaboration… more
- Merck & Co. (Rahway, NJ)
- …of our Research & Development Division is seeking applicants for an Associate Principal Scientist position available at its Rahway, New Jersey research facility.- ... The Associate Principal Scientist is a laboratory-based scientific role tasked...molecular biology and immunoassay techniques.Extensive knowledge and experience with regulatory guidance and industrial standards of control strategy for… more
- Merck & Co. (Rahway, NJ)
- …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
- Merck & Co. (Rahway, NJ)
- …Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance , Risk Management, Sourcing and Procurement, ... (as a lead GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines,- strategies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vendor programming implementation, and expedite the preparation of regulatory submissions. Responsibilities include: make strategic programming decision and ... analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review study submission data package and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good Clinical ... against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities:Reconcile the… 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, ... listings, SAP, Data Management plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in… more
- Merck & Co. (Rahway, NJ)
- …sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction ... of Associate Principal Scientist, and working in conjunction with internal...and trend evaluations, process characterization, new WCB qualification, and regulatory submission authoring, with a focus on standardization across… more
