- Merck & Co. (Rahway, NJ)
- …related to medical devices or the device constituent of a combination product. Review and approve Design Control and Device Risk Management documentation for ... regulatory filings, clinical supply, development, design transfer qualification and post marketing surveillance. Evaluate deficiencies and assess impact on… more
- Merck & Co. (North Wales, PA)
- …to the Director/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and ... objectives.Serve as the liaison and manages correspondence with FDA's promotional review divisions Office of Promotion and Advertising Review (OPDP)/Advertising… more
- Merck & Co. (Rahway, NJ)
- …company's clinical supply programs. This person will also independently review and approve documentation accompanying the disposition of API materials (including ... new modalities such as ADCs) manufacturing in a complex, clinical supply development.- Review and/or approve GMP...by site or organization, with Friday designated as a remote -working day, unless business critical tasks require an on-site… more
- Merck & Co. (Rahway, NJ)
- …well as the biopharmaceutic support for the oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will ... opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of robust compositions,… more
- Merck & Co. (Los Angeles, CA)
- …is a critical position where you will actively engage with scientific and clinical leaders in the cardiovascular field within your assigned geography.In this ... and supporting the transformation of our customer engagement strategies within the US Pharma - Chronic Care business. This...include any may not be limited to: Scientific and Clinical Leaders Engagement: Serve as a disease, product and… more
- Merck & Co. (Rahway, NJ)
- …Molecular Biomarkers (TMB) is responsible for translating preclinical molecular biomarkers to clinical development across all therapeutic areas and all phases of ... clinical development at our Company's Research laboratories. TMB laboratories...mechanisms of drug action and patient response.The Genomics group within the TMB organization is seeking a highly motivated… more
- Merck & Co. (Rahway, NJ)
- …and expand an already extensive network of key cross-functional partners both within TMed, Discovery, and Global Clinical Development.-The candidate will be ... at governance for the Cardiovascular & Respiratory portfolio (discovery therapeutic area review , early and late-stage clinical governance), and fully supportive… more
- Merck & Co. (Rahway, NJ)
- …potential medical breakthroughs.Support statistical programming activities for Early Oncology clinical development projects. Review the quality and reliability of ... statistical analysis and high-quality data to support decision making in clinical trials.Responsible for the development and execution of statistical analysis and… more
- Merck & Co. (Rahway, NJ)
- …and risks within our Company and with external suppliersAuthor and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for ... company, and customer requirements.-This position will lead cross-functional development teams within and external to Device Development & Technology. The incumbent… more
- Merck & Co. (AR)
- Job DescriptionOur Sales team support our customers by providing clinical information about products, educational information, clinical training programs and ... for covering the state of Arkansas.The selected candidate must reside within the territory.This position may require overnight travel.Travel (%) varies based… more
- Merck & Co. (Memphis, TN)
- Job DescriptionOur Sales team support our customers by providing clinical information about products, educational information, clinical training programs and ... northern half of Mississippi. The selected candidate must reside within the territory. The ideal residence within ...on the patient. Must understand impact and use of clinical trials in multiple tumor types/ therapies, both in… more
- Merck & Co. (Bronx, NY)
- Job DescriptionThe-Vaccine Customer Representative (VCR) supports customers by providing clinical information on our Company's vaccines, as well as education and ... (VCR) is the primary point of contact for a variety of customers within their assigned geography.- These customers may include:- health care providers such as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …input from functional area experts; Ensure key messages are clear and consistent within and across documentsCritically review documents produced by other writers ... advise study teams regarding regulatory requirements and ICH guidance for clinical documentsParticipate in initiatives within the Global Regulatory Writing… more
- Aequor (Thousand Oaks, CA)
- Fully Remote - Any time zone - Flexible hours Manager will be interviewing candidates and deciding which role would be best suited. Open to recent grad with some ... for our partners! Required Competencies and Skills: Key Responsibilities:1. Lead the review , drafting, and negotiation of contracts for members of the healthcare… more
- Merck & Co. (Rahway, NJ)
- …implementation of risk control measures.Analyze information from post-market surveillance, clinical evaluations, and real-world evidence to inform risk management ... and address project challenges, effectively communicating risk management strategies within the Device Development team and with external partners.Understand and… more
- Merck & Co. (North Wales, PA)
- …training materials for the Oncology Medical Affairs team through the appropriate review systems and serves as the medical approver of these materialsDesigns, updates ... or biotechnology company in Oncology, -or- 5 years of relevant clinical experience in medical oncology.Proven ability to effectively communicate (written and… more
- Merck & Co. (Rahway, NJ)
- …Organics (SSO) Pilot Plant is a Good Manufacturing Practices (GMP) facility within the Process Research and Development (PR&D) organization, which enables gain of ... critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training opportunities for… more
- Merck & Co. (Rahway, NJ)
- …molecules, biologics, and vaccinesBroad understanding of drug discovery, development and research, clinical data coding and experience working within a regulated ... and nomenclature data into a centralized databasePerforming data integrity review activities, including proofreadingDeveloping rules to ensure data qualityContributing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …continuous improvement Data-Driven Insights and Optimizations: Identify opportunities for improvement within the customer campaigns and engagement. Review and ... required Proven knowledge of the pharmaceutical industry, including medical, regulatory, clinical processes and market dynamics, especially within specified… more
- Ochsner Health System (River Ridge, LA)
- …with leadership to review processes with the goal of improving the clinical experience for referred patients and the referring physician. Adapts behavior to the ... Support (BLS) from the American Heart Association. Preferred - Certification in clinical specialty area. Knowledge Skills and Abilities (KSAs) Proficiency in using… more
