- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Director, Business System Labeling Management Required experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory ... experience strongly preferred, and experience with IT System/Business System Management .Education Min. Requirement: BS/BA or an equivalent certification/experience in… more
- Merck & Co. (Rahway, NJ)
- …and apply regulatory / compliance requirements relative to design controls and risk management activities.Lead the preparation of materials for program ... Job DescriptionDevice Development Associate Principal Scientist - Development Strategy, Design Controls( Associate Director Equivalent) Our company's Device… more
- 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. (San Francisco, CA)
- … Process, Managing Engineering Teams, Operational Metrics, Performance Monitoring, Project Management , Research Databases, Risk Management , Status Reporting, ... Job Description Position Description: Associate Director, DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS)… 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
- Merck & Co. (Rahway, NJ)
- …Project Management , Project Portfolio Management (PPM), Publications Management , Regulatory Compliance, Risk Management , Sourcing and Procurement, ... program(s) ( ie Bulk Drug Product).- - Oversees all bulk drug supply management and ensures proper allocation of drug product as needed across studies within… more
- Merck & Co. (Durham, NC)
- …the Supply Chain Logistics Strategy Leader will be responsible for the development, management , and growth of our warehousing and logistics operations, both on the ... business activities.- Reporting directly to the Director, Supply Chain Management , the successful candidate's primary responsibilities will include varying aspects… 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. (Upper Gwynedd, PA)
- Job DescriptionGRACS CMC - Associate Principal Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director/Director/Principal Scientist/Sr Principal ... including assessment of the probability of regulatory success together with risk mitigation measures.-Lead development and execution of global product and project… 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
- 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. (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)
- …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
- 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
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... Modalities, have a 10-15 group size composed of experienced, senior and associate scientists.- The successful candidate will effectively partner with Mixed Modality… more
- Novo Nordisk Inc. (Durham, NC)
- …and SME to operate within compliance with a quality mindset that focuses on risk management & mitigation Lead the training & implementation of effective change ... within compliance with a Quality Mindset that focuses on risk management and mitigation. Utilize the appropriate...study from an accredited university required May consider an Associate 's Degree in Engineering Technology or a relevant field… more
- Aequor (Davie, FL)
- …equipment and facility. May include job hazard analysis, failure fault trees, and risk assessments to drive a preventable injury work place and continuously safe ... considered. Education/Certification/Experience: Bachelor's degree with 5 years' experience or Associate Degree with 8 years' experience within pharmaceutical or… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Strong financial acumen with experience managing budgets, forecasts, and headcount planning. Risk Management : Ability to identify, assess, and mitigate ... execute daily production schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager, and Manager.Oversee the hiring, development, and… more
- Aequor (Houston, TX)
- …Corrective and Preventative Actions to reduce deviation recurrence, performance of Risk Assessments, Causing Mapping, Interviewing. Management of multiple ... for resolution in a timely manner. Participation in the Daily Management meetings to update leadership or current deviation statuses. Routine interaction… more
