- Merck & Co. (Rahway, NJ)
- …Data Management, Ethical Standards, Health Literacy, Informed Consent, Internal Inspection , Management Process , Manufacturing Compliance, Medical Writing, ... is responsible for developing informed consent deliverables per company process and standards, ensuring compliance with internal policy, regulatory requirements,… more
- Aequor (Thousand Oaks, CA)
- … inspection readiness Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and ... case follow up per SOPs Support medical coding conventions, and systematic process improvements for ICSR medical review Conduct reportability assessment for medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory Affairs ... (GRA) Process Excellence & Analytics function, responsible for ensuring Daiichi...in this role will also be responsible for overseeing inspection readiness and supporting internal audits and Health Authority… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …our cGMP commercial manufacturing facility. This role will work within our Process Engineering team focused on brownfield projects including: equipment upgrades, new ... to: Lead Engineer, Manufacturing Engineering (Supervisor) Essential Functions Leads process and equipment troubleshooting to support deviations, corrective actions… more
- Insmed Incorporated (San Diego, CA)
- …Medium Workplaces™ lists.OverviewWe are seeking a highly motivated expert in purification process development of viral vector gene therapy products. In this role you ... for performing experiments ranging from purification development and optimization, process characterization and clinical manufacturing investigation support. As part… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …to: Lead Engineer, Manufacturing Engineering (Supervisor) Essential Functions Leads process and equipment troubleshooting to support deviations, corrective actions ... in design and hazard reviews of plant expansions or process changes and serving as the technical point of...activities such as: reading, writing, and analyzing; and visual inspection . The working environment includes a variety of physical… more
- Novo Nordisk Inc. (Durham, NC)
- …and help us make what matters. The Position Seeking an experienced to Sr level Process Engineer to support the bulk process tableting line. This role will ... business & regulatory requirements through the following activities: People Focus, Process Focus, Equipment Focus & Standards "Gatekeeper". Relationships Reports to… more
- Aequor (Thousand Oaks, CA)
- …with clinical regulatory requirements, partner with key stakeholders to support inspection readiness for various clinical programs and clinical studies. Key ... Responsibilities: Inspection Readiness for clinical programs and studies - Retrieve...systems - Retrieve documents from external vendors - Create process and clinical study overviews/ storyboards and other inputs… more
- Genmab (NJ)
- …lab data, and protocol deviations and is a key driver for inspection readiness, regulatory compliance, and successful data submissions.The Associate Director will ... oversight of third-party data vendors, and promote best practices and process optimization to support business continuity and data consistency across programs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …from executed contract; and update CLM system/trackers throughout the process .Conduct Simple Negotiations: Review contractual amendment details against original ... change request; manage interactions with Vendor, finalize, and execute amendment.Audit Ready/ Inspection Prep: As per the audit requirement and processes, storage of… more
- Eisai, Inc (NJ)
- …relating to clinical study Trial Master Files (TMF), ensuring regulatory inspection -readiness and compliance with applicable laws and regulations. The Eisai eTMF ... globally. This role will identify, lead and participate in TMF system and process improvement initiatives, including SOP reviews, TMF reporting and serve as a… more
- Eisai, Inc (Nutley, NJ)
- …North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is ... audits of study sites, clinical vendors, clinical documents, and internal process audits Facilitate Sponsor health authority inspections of global clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …through partnering with stakeholders to streamline the product lifecycle process and develop risk mitigation strategies.Provide comprehensive quality oversight and ... Global Oncology Medical Affairs, Specialty Medical affairs, through lessons learned, process improvement and ongoing collaborations. Provide end to end process… more
- Merck & Co. (Durham, NC)
- …Vial washers, Depyrogenation Tunnels, Fillers with Isolator technology, Lyophillizers, Visual Inspection Machines along with all the support equipment prep and clean ... meeting timing commitmentsLeading in the identification and implementation of process improvement projects, productivity initiatives and corrective actions while… more
- Merck & Co. (Rahway, NJ)
- …a culture of initiative, creativity, and problem-solving Deliver robust DS process and analytical strategies to enable successful commercialization Provide technical ... oversight for DS process development, characterization, and regulatory filings Ensure smooth execution of PPQs and BLAs for pipeline assets Bring deep expertise in… more
- Merck & Co. (Rahway, NJ)
- …submission data standards including SDTM, ADaM, clinical site data for CDER inspection planning, etc.The incumbent will be responsible for continuous improvement of ... our electronic submission process and providing tools and templates to support delivery...Conversions.Demonstrated success in the assurance of deliverable quality and process compliance.Excels in technical writing, able to convert complex… more
- Repligen (Clifton Park, NY)
- …for area cleanlinessread and understand quality and inspection documentsread/understand molding drawingsbasic math competencyunderstanding of measuring ... supplies or manufacturing experience is a huge plus.Quality control or inspection experience is highly desirablePrevious experience working in a Cleanroom… more
- Merck & Co. (Rahway, NJ)
- …- Execute Good Manufacturing Practices (GMP) activities such as release, stability, and in- process testing of Biologics Drug Substance (DS) and Drug Product (DP). - ... registrations, product launches, and troubleshooting activities. - Support compliance audits, inspection activities, and investigation/CAPAs . - - - Author and… more
- Merck & Co. (Durham, NC)
- …Vial washers, Depyrogenation Tunnels, Fillers with Isolator technology, Lyophillizers, Visual Inspection Machines along with all the support equipment prep and clean ... company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an… more
- Merck & Co. (Rahway, NJ)
- …and service teams to understand and implement technology and process controls to meet the company's policy and regulatory obligations.Responsibilities:Engage ... the IT organization operates and complies with established policies/procedures.Supports audit/ inspection readiness and participates in the timely review and… more
