- Formation Bio (New York, NY)
- …treatments to patients faster and more efficiently.About the PositionWe are seeking an Associate Director, Program Management to drive the execution of critical ... seamless cross-functional coordination and execution.As a key member of the Program Management team, you will be responsible for translating strategy into execution… more
- Merck & Co. (Rahway, NJ)
- …(MLDP) which recruits and accelerates future talent for the division. The Associate Director, Alliance Management is responsible for managing multiple aspects ... enterprise manufacturing functions. This includes the Strategy and Portfolio Management office, Global Supply Business Development (GSBD) which evaluates… more
- Merck & Co. (Rahway, NJ)
- … Risk Assessments, Quality Assurance Processes, Quality Assurance Systems, Quality Management , Quality Oversight, Quality Risk Management , Quality Systems ... activities and develop strong working relationships with external quality management personnel. The incumbent would be the key quality representative… more
- Merck & Co. (Durham, NC)
- …goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , Product Release, Change Control).- ... and ensuring excellence in Compliance, Supply, Continuous Improvement, and Cost Management .--The Associate Director, External Manufacturing Operations will also… more
- Merck & Co. (Rahway, NJ)
- …Plan for each MDCP Program (with target dates) for execution.Leads Quality/Compliance Risk Assessments including Quality Risk Management Plans, mitigation ... of the Device Quality & Regulatory QMS group, the Associate Director will participate in and/or lead various initiatives...support of our QMS Purchasing Controls and Device Supplier Management objectives and build QMS capabilities that touch every… more
- Merck & Co. (Durham, NC)
- …have the safest and most compliant operation around the network.EMSS has an Associate Director opening for the Bulk Facility (GBF) maintenance team. The selected ... ensure area safety, compliance, production and financial goals are metSpare parts risk -based assessments and identification of new parts to replace obsolescent parts… more
- Merck & Co. (Rahway, NJ)
- …leveraging digital, data and analytics and measuring the impact. The Associate Director, Global Commercial Pharma Pipeline Analytics, HHDDA will be responsible ... and proactively "connect the dots" across HHDDA cross functional teams. The Associate Director will also be responsible to support concrete recommendations and… more
- Merck & Co. (Rahway, NJ)
- …(MCAAS) primary purpose is to provide value-added independent and risk -based audit and assurance services.Position Overview / Function and ResponsibilityThe ... Associate Director:Leads a small team through financial and compliance...audits and assessments.Demonstrates knowledge of and techniques to assess risk and evaluate the effectiveness of internal controls in… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director, Sustainability Strategy & Engagement will join the Company as a member of the Social Impact and Sustainability (SIS) function, ... sustainability, access to health, employee engagement, and ethics and values. The Associate Director will serve as a trusted advisor to business leaders ,… more
- Merck & Co. (Rahway, NJ)
- …launch planning tool, ensuring adherence to timelines, budgets, and resource allocation. Risk Management : Identify potential risks and interdependencies across ... who are passionate about driving impactful changes. Position Overview: As the Associate Director of Launch Strategy and Operations, you will lead the enterprise… more
- Eisai, Inc (Nutley, NJ)
- …Drafting and Negotiation, Industry/ Regulatory Knowledge, Legal & Reputational Risk Management , Legal Knowledge, Mentoring/ People Development, Stakeholder ... Compliance)Eisai Salary Transparency Language:The base salary range for the Associate Senior Counsel, Market Access is from :189,100-248,200Under current guidelines,… more
- Merck & Co. (North Wales, PA)
- …and preparing for numerous potential launches of our medicines and vaccines. As Associate Director, Launch Excellence, you'll play an important role in preparing for ... and cross-functional interdependencies across all launch workstreams.Lead scenario planning, risk assessments and prioritization of critical launch activities.-Create end-to-end… more
- Merck & Co. (North Wales, PA)
- …design across multiple dimensions (customer, channel, content, cadence).Demonstrated change management skills with ability to lead, advocate, influence, and ... broad audiences.Innovative mindset with affinity toward experimentation and appropriate risk taking.Demonstrated ability to lead complex projects/solutions with hands-on,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …updates from the drug side, as needed. Provide RA specific inputs into CDx Risk Management plans for individual projects/indications. Assist the CDx team with ... of CTA/CDx within clinical trialsDevice protocols and SAPsDevice non-significant/significant risk determinations (both submission to CDRH in a Q-sub process… more
- Merck & Co. (Rahway, NJ)
- …to Schedule and Budget for Deliverables, Leadership of Teams, Vendor Management , And Demonstrated Communication With Senior LeadersAPI Small Molecule Manufacturing ... and Potent Compound Handling ExperienceProcess Safety Management , Emergency Management , And Incident InvestigationsFacilitating Process Hazard Analysis and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …documents where necessary with supervision. This position conducts regulatory risk assessment and recommends developmental options with supervision, and this ... years direct or related CMC regulatory experienceSuccessful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and EMA… more
- Aequor (Thousand Oaks, CA)
- …Deep understanding of Risk Based approaches and its impact with Data Management /Site monitoring operationally - consider the role of both Data Management and ... of Pinnacle 21, Centralized Statistical Monitoring, Quality by Design, Risk -based Quality Management etc. Determine key performance...OR Bachelor's degree and 6 years of experience OR Associate 's degree and 10 years of experience OR High… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …consistently and proactively represented at program level and support proactive quality risk management process.Interact with the audit and compliance function ... of MA risks identified through audits, inspections, internal meetings, remediation and risk management in close collaboration with the organization's quality … more
- Merck & Co. (Boston, MA)
- … Management , Budget Management , Building Leadership Teams, Change Management , Clinical Operations, Clinical Risk Management , Clinical Site ... Job DescriptionThe Associate Vice President/Regional Head, North America, manages all...and optimization of key processes, talent and succession - management , overall operating budget management and oversight… more
- Merck & Co. (Rahway, NJ)
- …Documentation, Clinical Investigations, Clinical Judgment, Clinical Medicine, Clinical Research, Clinical Risk Management , Clinical Site Management , Clinical ... in the execution of clinical studies.--Will report and work collaboratively with the- Associate Vice President to promote the development strategy of the company on… more
