- Merck & Co. (Chicago, IL)
- Job DescriptionRole SummaryThe Regional Medical Scientific Director (RMSD) is a credentialed (ie, PhD, PharmD, DNP, MD) therapeutic and disease expert who engages in ... including field standard operating procedures (SOPs), Good Clinical Practice ( GCP ) guidelines, and administrative/operational responsibilities.PreferredField-based medical experienceResearch ExperienceDemonstrated record… more
- Insmed Incorporated (San Diego, CA)
- …for Millennials™, and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical ... and maintain a risk-based and scientific-based quality system to support GCP .Oversee regulatory agency inspections and vendor audits.Ability to ensure that a… more
- Merck & Co. (Chicago, IL)
- …DescriptionWe are seeking a Growth and Improvement minded Regional Medical Scientific Director (Medical Science Liaison / MSL) - in Inflammatory Bowel Disease ... our Strategic Operating Priorities.Summary, Focus and PurposeThe Regional Medical Scientific Director (Medical Science Liaison) is a credentialed (ie, PhD, PharmD,… more
- Merck & Co. (North Wales, PA)
- …the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability to manage competing priorities and effectively ... delegate and assign activities to meet the business needsAbility to develop short and mid-range project plans that are realistic and effective at meeting goals.Strong analytical skills to drive operational milestones Influence opinions and decisions of… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director , Clinical Quality Assurance position is ... Quality management system. This role is responsible for Good Clinical Practice ( GCP ) oversight, and for assuring the compliance of projects, products and programs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oversight groups for case processing activities and reports to the Director of PV Case Management.Responsibilities:ICSR Processing: Oversees QC activities, supports ... clinical and safety databases, preferredFamiliarity with Good Clinical Procedures ( GCP ) and Good Pharmacovigilance Procedures (GVP) preferred Daiichi Sankyo, Inc.… more
- Twist BioScience (South San Francisco, CA)
- Sr. Director , Manufacturing Execution System (MES) (Hybrid in South San Francisco)Job DescriptionWe are seeking an experienced and highly motivated Manufacturing ... Execution System (MES) Director to lead the strategic development, implementation, and optimization of our custom, in-house developed MES solutions across our… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and direction for the global regulatory ... to ensure effective achievement of regulatory/business objectives. The Executive Director will direct the development and submission of investigational drug… more
- Merck & Co. (North Wales, PA)
- …data/medical protocol deviations in collaborations with the Clinical Director .Other responsibilities include:Collaborating cross-functionally in the development of ... the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing priorities with good planning,… more
- Merck & Co. (Rahway, NJ)
- …data/medical protocol deviations in collaborations with the Clinical Director . Other responsibilities include: Collaborating cross-functionally in the development ... Core Skills Solid knowledge of clinical research regulatory requirements (e . g . , GCP and ICH) Ability to manage multi e competing priorities with good -planning ,… more
- HCA Healthcare (Nashville, TN)
- …Do you want to join an organization that invests in you as a(an) Data Engineering Director - GCP ? At HCA Healthcare, you come first. HCA Healthcare has committed ... opportunity to make a difference. We are looking for a dedicated Data Engineering Director - GCP like you to be a part of our team. **Job Summary and… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …for the successful oversight and completion of a broad spectrum of GCP audit activities and deliverables across large sites, countries, or multiple regions. ... as a primary point-of-contact to assigned R&D groups and advise on: GCP regulatory requirements; relevant Gilead policies and procedures supporting audits and… more
- Regeneron Pharmaceuticals (Armonk, NY)
- The Associate Director , Global Development Quality Inspection Management (GDQIM) acting as an Inspection Management Lead (IML) is a key position that is responsible ... for the effective management of GCP , GVP and GLP inspections. The GDQIM IML will...if have:** * Advanced knowledge, understanding and application of GCP , and/or GVP guidelines including the management of significant/complex… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …and team management. As a member of the Global Development Quality Governance & Oversight (GDQGO) Leadership Team, this role involves overseeing the Global ... Development Quality Vault, ensuring robust Computer System Validation (CSV) and quality oversight for equipment and assay qualification activities, while promoting a culture of continuous improvement. **A Typical Day in the Role Might Look Like:** + Plan and… more
- Amgen (Washington, DC)
- …vendors though: + Working with suppliers and internal customers (typically up to Director level) to identify, lead, raise and resolve issues related to supplier ... a global, matrix organization. + Knowledge of Good Clinical Practices ( GCP ), FDA regulations and guidelines, and international regulatory requirements/guidelines. +… more
- Tiffany & Co. (Parsippany, NJ)
- **Position Overview:** Tiffany & Co. is seeking a Director - Principle Data Architect to join our team as we are in a journey to the Google Cloud Platform. We are ... Analytics program by consolidating our legacy data platforms onto GCP through re-design, and we will be enabling a...delivered reporting. This important role will help lead our GCP architecture, roadmap, and integration strategy, as well as… more
- Otsuka America Pharmaceutical Inc. (Olympia, WA)
- …patient outcomes and optimize business processes. **About This Role** The Director , Cloud Operations is responsible for managing, operating, and enhancing our ... cloud environments on AWS and Google Cloud Platform ( GCP ), ensuring optimal scalability, security, reliability, and performance in alignment with our growth… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- We are seeking a Associate Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the development, ... study data of a clinical development program. The Associate Director leads in a matrix environment as part of...maintaining compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical… more
- Palo Alto Networks (Santa Clara, CA)
- …opportunities - just to name a few! **Your Career** As a Senior Consulting Director within Unit 42's Cyber Risk Management (CRM) team, you will lead our Cloud ... and thought leadership, and advancing service innovation. Working closely with the Managing Director and CRM NAM Practice leader, along with peers in North America… more
- SMBC (Phoenix, AZ)
- …life. **SUMMARY:** Jenius Digital Bank is seeking a strategic and technically skilled Director of Data Architecture to lead the design and implementation of our ... governance frameworks, and AI/ML enablement, primarily on Google Cloud Platform ( GCP ). The ideal candidate will drive innovation, ensure scalability, and collaborate… more