- Merck & Co. (Rahway, NJ)
- Job Description Job Description The Rahway based Senior Specialist, Global Development Quality Operations - API, is responsible for independent review and approval ... and other applicable worldwide regulations and our Company procedures.- The Senior Specialist will become knowledgeable in regulatory requirements, cGMPs and our… more
- Merck & Co. (Rahway, NJ)
- …technical responsibility and leadership of internal and external work.The Senior Scientist, Engineering position leverages scientific/technical experience to develop ... candidate will provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical design of experiments. This… more
- Merck & Co. (Rahway, NJ)
- …to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within Research Laboratories is committed to rapidly delivering ... and engage with the scientific community to influence the field.As a Senior Principal Scientist, you will drive various strategic initiatives and translate… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Senior Engineer in Device Design and Process Development group, you will be part of our Research & Development team that designs and develops ... technical content of assembly process FMEAs to capture patient and process risk and identify appropriate in-process controls to ensure robust and efficient… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM ( Risk Based Quality Monitoring) sets the ... pharmaceutical industry across different disease areas, and the ability to determine risk factors with and for other technical departments (eg, Clinical, Medical,… more
- Eisai, Inc (Nutley, NJ)
- …and Negotiation, Industry/ Regulatory Knowledge, Legal & Reputational Risk Management, Legal Knowledge, Mentoring/ People Development, Stakeholder Management ... Salary Transparency Language:The base salary range for the Associate Senior Counsel, Market Access is from :189,100-248,200Under current guidelines, this… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and propel data-driven decision-making.Promotes a culture of creativity and risk -taking, alongside developing processes that encourage experimentation and innovative ... and rotations.Demonstrate analytics' value in solving complex business challenges.Engage senior leaders to drive strategic analytics transformations.Partner with Data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of the Head of Functional Excellence, across key functions to improve the benefit- risk in patients treated within the oncology compounds throughout the course of ... at the site level to ensure that patient safety with respect to the safety risk assigned remains top of mind in the context of patient management in the clinical… 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)
- …administration including inhalation, implantation, and injection.--This position serves as a senior individual contributor who will be responsible for applying deep ... experts within the broader DD&T team (eg design verification, device risk management, human factors, technical integration, assembly automation, etc.), as well… more
- Repligen (Waltham, MA)
- …highly motivated and collaborative professionals responsible for managing supplier qualification, risk mitigation, and quality performance. The team plays a key role ... is based in Waltham, MA, and will report to the Senior Manager of Supplier Quality.Responsibilities Supplier Performance Monitoring and ReportingCollect, analyze,… more
- Merck & Co. (Rahway, NJ)
- …and Biopharmaceutics, have 10-15 direct reports composed of experienced, senior and associate scientists.- The successful candidate will effectively partner ... 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)
- …Urgent role. Shortlisting will begin EOD Weds 7/23 Standard business hours Supply Chain Senior Manager - Global Supply Chain Leader What you will do Let's do this. ... patient supply. With the end-to-end supply chain oversight of products, the Senior Manager will be responsible for establishing supply chain resolutions to mitigate… more
- Merck & Co. (Rahway, NJ)
- …apply regulatory / compliance requirements relative to design controls and risk management activities.Lead the preparation of materials for program presentations for ... experienceHas broad knowledge of medical device development, design controls and risk managementLed and managed development of DHF (design history file) deliverables… more
- Merck & Co. (Durham, NC)
- …Meetings (with External Partner).-- Compliance:-Achieve compliance goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management, ... provide Operations input into Supply and Quality Agreements.- Launch Supply Risk Mitigation:-Ensure External Partner Site Readiness, Assist with Technology Transfer,… more
- Formation Bio (New York, NY)
- …requirements. Identify opportunities for cost savings, contract optimizations, and risk mitigation. Implement procurement analytics and reporting tools to provide ... vendors, and other biotech service providers. Knowledge of contract law, risk management, and compliance in vendor agreements. Ability to work cross-functionally… more
- Merck & Co. (Rahway, NJ)
- …desired results. Reviews and defends stage-gate deliverables for programs including risk assessment and mitigation plans and engages in corporate governance meetings ... relationships with health authorities.- Leads, develops, and coaches a team of senior level employees to effectively manage programs and enable rapid and effective… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager, and Manager.Oversee the hiring, development, and performance management ... financial acumen with experience managing budgets, forecasts, and headcount planning. Risk Management: Ability to identify, assess, and mitigate operational and… more
- Merck & Co. (Durham, NC)
- …strong individual and has the ability to communicate effectively with senior management on complex technical issues and manage multiple high-priority, complex ... functions.Demonstrated skills in complying with one or more regulatory programs: RCRA and High- Risk Work (eg elevated work, confined space, hot work, lock out tag… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …enterprise technologies and will also be responsible for performing technical risk and vulnerability assessments at the network, system, and application level. ... responsibilities developing and implementing security controls and formulating operational risk mitigations. Relationships: Reports directly to the manager of Global… more
