- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high impact projects, fostering s culture of ... excellence and compliance and working toward building a quality mindset with...with GCP, GPV, GPEP, Data Protection, and other local regulatory requirements throughout the planning and execution of Interventional,… more
- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities: Strategic Leadership and Project ... performance of team members, fostering a collaborative and innovative team environment. Regulatory Compliance and Quality Assurance: Ensure that all activities… more
- Merck & Co. (Boston, MA)
- …stakeholders to ensure alignment with clinical development timelines and regulatory requirements. Most importantly, the role requires overseeing CDx development, ... stay up to date regarding industry trends and diagnostic regulatory requirements. Essential Job Requirements:Develop end-to-end diagnostic strategy in collaboration… more
- Merck & Co. (South San Francisco, CA)
- …Within QP2, you have a uniq ue oppor t unity to accelerate your professional career as a quantitative drug developer taking advantage of our end-to-end pipeline ... external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and ensures that material is fully released prior to shipment to siteEnsures compliance with all domestic and foreign regulatory requirements but may seek ... and GCPs and is compliant with domestic and foreign regulatory requirement but may seek support on such items...may compromise patient dosing or safety. Basic understanding of professional working environment as well as Quality Assurance and… 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
- Merck & Co. (Rahway, NJ)
- …pre-filled syringes and autoinjectors.- This Director will be responsible for the professional development of team members, as well as driving transformation within ... external stakeholders such as drug substance, drug product, device, analytical, regulatory , project leaders, manufacturing sites, and other key stakeholders in CMC… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execute audits effectively. Ensure the internal systems auditing program fulfills regulatory requirements performs audits, identifies compliance issues and ... audits, remediations implemented and CAPAs pending.Support Risk Mitigation programs to ensure compliance to regulatory guidelinesEnsure up to date audit CAPA… more
- Merck & Co. (Rahway, NJ)
- …with stakeholders in partner organization and to management and governance teams.Support regulatory filing by authoring and reviewing regulatory submissions and ... data in context of broader process and product development.-Working knowledge of regulatory guidance and quality standards, with experience authoring and reviewing … more
- Merck & Co. (Rahway, NJ)
- …Leadership Mentoring, Pharmaceutical Process Development, Professional Collaboration, Professional Networking, Quality by Design, Regulatory Filings, Social ... different stages of clinical development, 2) process characterization and regulatory filings for successful commercializationAdvance upstream processes by improving… 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 ... dataProduce tables and graphics for inclusion in study reports and regulatory submissionsEnsure programmatic traceability from data source to modeling resultSupport… more
- Eisai, Inc (Nutley, NJ)
- …with existing and emerging Key Opinion Leaders (KOLs), Advocacy Groups and Professional Societies to develop and implement AD education that helps simplify the ... speaker programs for meaningfulness, effectiveness, educational in nature, and compliance with company policies. Essential Functions KOL Engagement Engage with… 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 (Thousand Oaks, CA)
- …You will collaborate across functions, troubleshoot distribution issues, and ensure compliance with regulatory and quality standards. Key Responsibilities and ... will be provided.The ideal candidate is a local Los Angeles/Ventura County supply chain professional who can work remotely but commute onsite once per month and in… more
- Repligen (Waltham, MA)
- …reporting (ICFR) in compliance with Sarbanes-Oxley (SOX) requirements.Ensure compliance with accounting standards and regulatory requirements, including SEC ... analytical approach with teams across the organization. Internal Controls & Compliance :Design, implement, and maintain effective internal controls over financial… more
- Eisai, Inc (Pittsburgh, PA)
- …approved promotional clinical trials, patient access to medication, and regulatory / compliance guidelines preferred.Experience with account planning and ... to relevant customer stakeholders in a compliant way.Monitor operating costs and compliance with territory budget.Seek out mentorship to learn and build key sales… more
- Merck & Co. (Rahway, NJ)
- …need and assigned based on the individual's unique skill set, professional interests and development opportunities. After completing the program, participants can ... acumen such as product knowledge, healthcare systems, payors and customers, regulatory , business operations and reputational risks while working intimately with our… more
- Merck & Co. (Rahway, NJ)
- …cardiology, pain & inflammation, reproduction, drug delivery or biotechnologyKnowledge of regulatory aspects of pharmaceuticals including GLP, GCP and GMPAbility to ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Merck & Co. (North Wales, PA)
- …Excellence, Oral Communications, Pharmaceutical Management, Product Registrations, Professional Networking, Project Management, Regulatory Requirements, ... the external community (Key Scientific Leaders, Patient Community, Payers, Regulatory Agencies)Responsible for managing, coaching, and mentoring Clinical Directors… more
- Lundbeck (Atlanta, GA)
- …issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/ Compliance - Apply knowledge of pharmaceutical and regulatory ... Panthersville, Atlanta, Washington SUMMARY: Are you a results-driven biopharmaceutical sales professional looking to be part of an organization that values being… more
