- Formation Bio (New York, NY)
- …mission to bring new treatments to patients faster and more efficiently.About the PositionThe Director , Quality Management Systems plays a pivotal role in ... Proven experience in developing, implementing, and managing pharmaceutical quality management systems, including document control, training management ,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data ... validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to identify and recruit talent. preferred Licenses and Certifications:Certified Project Management Professional (PMP)-PMI and/or training in project ... around rare diseases and immune disorders. Summary The Sr Director GPM&L is accountable for delivering an integrated drug...to ensure delivery of projects within cost, time and quality requirements. As a leader in GPM&L this position… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop ... ready to make a difference? The Position The Scientific Global Medical Director will provide leadership, direction, and guidance for the development and… more
- Merck & Co. (Millsboro, DE)
- …(USDA, DEA, DNREC, etc.) of animal facilities and program reviews is required.PurposeThis Associate Director will report to the Site Quality Head/ Director of ... compliance with all federal and state regulatory requirements for animal welfare, management of controlled substances, quality control testing according to GMP… more
- Insmed Incorporated (San Diego, CA)
- …Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Senior Director , DSPV Gene Therapy Safety Lead will be the safety expert for ... of the assigned product portfolio and safety profiles for products. The Senior Director will be responsible for the day-to-day direction to ensure business needs and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... responsibilities include input into convention planning/staffing, POA planning/staffing, sales training , product labeling committees and other department projects/initiatives This… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …people management individual contributors to ensure effective performance management , team collaboration, training and development, employee engagement, and ... a collaborative work culture, including direct partnership with the Operations Director (s) Stakeholder Management : Build strong internal and external… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ManagementAct as change agent to promote a culture of continuous improvement and quality awareness. Design, deliver and implement training programs worldwide to ... areas centered around rare diseases and immune disorders. JOB SUMMARYThe Associate Director , GMP QA Process Excellence is accountable to collect information, analyze… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …packaging and labeling. This position will interface with Operations, Regulatory, Quality Assurance, Finance, R&D, Project Management and Quality ... Position SummaryThe Sr. Director of Technical Transfer is responsible for activities...scale-up, process optimization, customer technology transfer activities with project management assistance.Provide SME information on the request for pricing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... in the assigned therapeutic area. Relationships Reports to the Executive Director - Clinical Research & Development. Internal relationships include working with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …internal and external (especially regulatory, but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned ... as well as other research areas centered around rare diseases and immune disorders.SummaryThe Director , Clinical Safety, will be a product safety lead or part of a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position is responsible for implementation and oversight of the Risk Based Quality Management (RBQM) principles that support the Company's vision including ... a Quality by Design (QbD) and Risk-Based Quality Management (RBQM) approach to clinical trial...as required. People Management Leadership:Accountable for the management , development, recruitment and training of employees… more
- Twist BioScience (South San Francisco, CA)
- …to lead our global marketing efforts and drive sustainable growth. The Sr Director , Marketing is responsible for leading all aspects of Twist's global marketing ... activities related to launching new products; and interfacing with customers. The Sr Director , Marketing also will lead growth marketing, social media and trade show… more
- Merck & Co. (North Wales, PA)
- …on scientific education and dialogue Business and market knowledge, including quality management . Excellent interpersonal, communication, and networking skills ... Job DescriptionThe Hematology Regional Medical Scientific Director , RMSD, is a credentialed (ie, MD, PhD, or PharmD) therapeutic and disease expert who engages in… more
- Genmab (Plainsboro, NJ)
- …operations of the US Sales & Marketing teams. Key areas include Congress management & oversight; Speakers Bureau management & oversight; Processing of commercial ... displays, exhibits & sponsorships; Promotional materials reviews; Print production; Management of external vendors; and interaction with alliance partners. The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of the relevant HRIS Module(s) including technical process and annual cycle management , documentation, testing, training and support materials for end-users, ... handling of queries, troubleshooting, and quality control.Lead or support consulting and implementation projects in the area of SuccessFactors, especially… more
- Merck & Co. (Rahway, NJ)
- …mode - Planning / Development & Production Enhancement Requirements / User training / Co-ordination to align with business priorities; Perform UAT, Provide feedback ... for traceability / lineage and make them available for business consumption; Monitor data quality report and work proactively with IT on data issues as part of daily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for ... of trial, clinical trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input on ICF creation;… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …scientific expert meetings, symposia etc.) Works in collaboration with the Global Medical Director (s) to co-develop and conduct live training at global ... Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop… more
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