- Merck & Co. (Rahway, NJ)
- Job DescriptionDevice Development Associate Principal Scientist - Development Strategy, Design Controls( Associate Director Equivalent) Our company's Device ... apply regulatory / compliance requirements relative to design controls and risk management activities.Lead the preparation of materials for program presentations for… more
- Merck & Co. (Rahway, NJ)
- …date: -As soon as possible.Job Description: Seeking a full-time Business System Associate for the Labeling Operations area within the GRACS Regulatory Innovation & ... Identify and design improvement opportunities within the Support Model to reduce compliance risk and increase efficiency for the Support Team and End Users. Conduct… more
- Merck & Co. (San Francisco, CA)
- Job Description Position Description: Associate Director, DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS) ... Under the broad guidance of the DSCS Digital Program Mgmt Lead, the Associate Director, DSCS Digital Project Manager, will be responsible for implementing improved… more
- Merck & Co. (Rahway, NJ)
- …who are passionate about driving impactful changes. Position Overview: As the Associate Director of Launch Strategy and Operations, you will lead the enterprise ... planning tool, ensuring adherence to timelines, budgets, and resource allocation. Risk Management: Identify potential risks and interdependencies across launch… more
- Merck & Co. (Rahway, NJ)
- …needed. D emonstrates high capability to solve unstructured problems, make informed risk decisions considering both technical & business risks, & influence portfolio ... Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance, Risk Management, Sourcing and Procurement, Strategic Planning {+ 5… 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. (Durham, NC)
- …Operations, Drug Delivery Systems and Devices within our Manufacturing Division ( Associate Director).-This role serves as a Virtual Plant Manager - responsible ... for all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a strong… more
- Merck & Co. (Durham, NC)
- …degree of accuracyStrong analytical and problem-solving skills.- Strong risk -based decision-making skills.A positive, collaborative, consensus building approach to ... management and interpersonal relationships that focuses on guiding, training and developing personnel to their fullest potential. Preferred experience and skills: Master's degree in science / engineering / business or supply chain management-Experience in… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking an Associate Director, Program Management to drive the execution of critical drug ... solutions to common program challenges, including resource constraints and risk mitigation strategies. Develop contingency plans for critical program elements… 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)
- …and Negotiation, Industry/ Regulatory Knowledge, Legal & Reputational Risk Management, Legal Knowledge, Mentoring/ People Development, Stakeholder Management ... 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of CTA/CDx within clinical trialsDevice protocols and SAPsDevice non-significant/significant risk determinations (both submission to CDRH in a Q-sub process ... from the drug side, as needed. Provide RA specific inputs into CDx Risk Management plans for individual projects/indications. Assist the CDx team with the creation… more
- Merck & Co. (Rahway, NJ)
- …Management, And Incident InvestigationsFacilitating Process Hazard Analysis and Execution of EHS Risk Assessments.Must Have At Least 2 Years of Experience in The ... Following:Product Development and Commercialization with Focus on Pilot PlantsDetailed Understanding of Level of Protection Analysis (LOPA), Including FacilitationApplying Knowledge of Regulations/Industry Guidance (NFPA, ATEX, CE, And OSHA)Process And Product… 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 ... position acts as the company liaison with the Health Authority (eg, US FDA and EU EMA) for assigned projects with support, on CMC matters. This position supports Health Authority Meetings (eg, preIND, EOP2, pre-NDA, Type C, Scientific Advice) with supervision,… more
- Merck & Co. (Rahway, NJ)
- …have 10-15 direct reports composed of experienced, senior and associate scientists.- The successful candidate will effectively partner with Biologics ... policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate will also… more
- Aequor (Thousand Oaks, CA)
- …stats programming, TA) to optimize trial delivery. Deep understanding of Risk Based approaches and its impact with Data Management/Site monitoring operationally ... the model which will deliver studies with an appropriate risk -based approach, eg. reduced SDV etc Develop and document...OR Bachelor's degree and 6 years of experience OR Associate 's degree and 10 years of experience OR High… 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
- Novo Nordisk Inc. (Durham, NC)
- …SME to operate within compliance with a quality mindset that focuses on risk management & mitigation Lead the training & implementation of effective change ... manage assignments within compliance with a Quality Mindset that focuses on risk management and mitigation. Utilize the appropriate cLEAN® tools when relevant Lead… more
- Merck & Co. (Rahway, NJ)
- …(SORs) to promote fast and efficient closure.As needed, safely perform High Risk Work involving hazardous energy control.Identify and follow through on opportunities ... and other facility improvement activities. Position Qualifications: Education Minimum Requirement: Associate in science, associate in applied science (ideally… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …execute daily production schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager, and Manager.Oversee the hiring, development, and ... financial acumen with experience managing budgets, forecasts, and headcount planning. Risk Management: Ability to identify, assess, and mitigate operational and… more
