- Merck & Co. (Rahway, NJ)
- …applicable regulatory requirements, regulatory filings and company policies.The Associate Director also ensures that effective and robust Quality systems are ... Job DescriptionThe Associate Director , ESQL is responsible for...all applicable policies and procedures of the Company and compliance with all governing regulations.Responsibility for Quality … more
- Merck & Co. (Durham, NC)
- …distributed in alignment with our incredibly high standards of quality . The Quality Assurance Associate Director will provide critical support in ... under the appropriate conditions.- - Position Responsibilities: Reporting to the Director , Quality Assurance will independently manage team and… more
- Merck & Co. (Durham, NC)
- …the new HPV vaccine drug substance manufacturing facility. As a direct report to the Director of Operations, the Associate Director will be accountable for ... make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and productivity.Key Responsibilities Co-Lead Deviation Investigations: Collaborate closely with the Quality Associate Director to co-lead the deviation ... treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance ...to prioritize investigations based on potential impact on product quality , patient safety, and regulatory compliance . Address… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionPosition Description: Associate Director - Site Digital Technology Lead The Site Digital Technology Lead is the representative for Global Animal ... accountable for the full technology stack across all aspects of Operations, Supply, Quality and Business support at the Millsboro site. The Site Digital Technology… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and ... of data is suitable for regulatory submission. The Associate Director will have routine interaction with...management of CROs and 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(from business understanding, over hands-on development to dissemination), to ensure high quality deliverables are on time and within budget. The position holder ... validation and dissemination- Identify innovative ways to improve the efficiency, quality and productivity of AI/ML activities and actively contribute to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... difference? The Position The Assoc Director OED - Supplies, is responsible for US and...processes and implementing changes to enhance efficiency, productivity, and quality . Encouraging a culture of continuous improvement, promoting innovation,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes ... by managing labeling development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to Core Data Sheets for… more
- Merck & Co. (Rahway, NJ)
- …forecastStrong partnership and alignment with EIT Finance and IT PMOEnsure compliance with IT financial controls and standardsQualifications, Skills & Experience: ... and renewals.- The incumbent will be responsible for ensuring the consistency, quality , reliability, efficiency of the information used to make financial decisions… more
- Merck & Co. (Rahway, NJ)
- …reliance on automation within Biologics Process Research & Development (BPR&D).The Associate Director role-will provide process automation leadership within the ... SOPs for all GxP automation systems.-Integration of control systems with MES, Quality , and Batch Reporting applications.Understand and adhere to CFR, GMP, and data… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …focusing on optimizing patient care and support. Relationships Reports to the Director of PSP Analytics and Ops Excellence. Key internal relationships include ... commercial insights and analytics, Privacy, Legal, Compliance , marketing, Market Access, Pricing Contracting Ops and Reimbursement, Finance, IT, etc. Other internal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …manage, with limited direction, Biostatistics study activities assigned and ensure high quality deliverables are on time and within budget. The position may also ... matter expert in meeting or teleconferences with Health Authorities. Ensure compliance with international regulations. Ensure inspections readiness as well as… more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities related ... development.#LI-TS1Eisai Salary Transparency Language:The base salary range for the Associate Director , Clinical Outsourcing is from :157,200-206,300Under… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the CMR Training representative; Liaise with global and HQ counterparts to promote quality and consistency across regions. Ensure compliance with SOPs, KPIs, ... CMR training strategy Ensuring CMR employees receive training on regulatory compliance , quality standards, GxP requirements and industry-specific guidelines as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance ... Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for ... regulatory process optimizations on relevant topics.Responsibilities- Supports CMC regulatory compliance activities for portfolio biologics to meet US, International… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review study submission data package and ... ensure its quality and integrity.- Provide hands-on statistical programming support to...template on datasets and TFLs to improve efficiency and quality . Responsibilities include: contribute to CRF and SDTM standard… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables on time and within budget to support drug development ... management deliverables for all studies within the project/program level meets quality , time and cost effectiveLeads functional and/or multidisciplinary teams… more
- Catalent (Harman, WV)
- …stakeholder satisfaction.Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, ... Senior Director , Supply Chain Position Summary: The Senior ...process of business recovery of cost changes as appropriate.Maintain compliance with all regulatory requirements and ethical standards related… more
