- Russell Tobin & Associates (Dublin, OH)
- What are we looking for in our Land Development Project Manager ? PrideNow is seeking a talented Land Development Project Manager to join an environmental ... work assignments to internal project teams and subcontractors Interact with regulatory agencies knowing what information to provide, when, and with appropriate… more
- Aequor (Newbury Park, CA)
- …training materials and presentations to a global audience. Author/review/approve quality Regulatory Information Management & Systems documents Analysis of the ... This will be a 100% remote role. The hiring manager confirmed they are looking for someone who works...would need someone who is comfortable with learning new systems , has experience managing content in SharePoint, has working… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …approach to facilitate consistency and quality of data across key Daiichi Sankyo regulatory systems . This includes defining regulatory data standards, data ... centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key...reporting capabilities, incl. creating reports and dashboards of key regulatory data/metrics from across systems , leveraging technical… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional activities ... validation and migration activities relating to new or existing systems in Regulatory AffairsRequired Skills5 years of...relating to new or existing systems in Regulatory AffairsRequired Skills5 years of Regulatory Operations… more
- Novo Nordisk Inc. (Durham, NC)
- …dynamic environment Champion for cGMP compliance, to include ensuring internal and external regulatory compliance of all site systems Ensure IT systems ... what matters. The Position Provides leadership & guidance to IT systems staff responsible for IT automation and infrastructure, security, networking, compliance,… more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management ... and Drug Administration (FDA) standards and batch record specifications.The incumbent uses systems thinking and a holistic systems -based approach to drive… more
- Aequor (Austin, TX)
- …for signature, and store for compliance. Ideal Capital Projects Sourcing Manager candidate: 5 years hands-on capital construction experience in procurement and ... contracting negotiations and execution. is searching for a Capital Projects Sourcing Manager , who will be responsible for helping execute the sourcing processes… more
- Merck & Co. (Rahway, NJ)
- …Ability to assess and mitigate risks associated with changes to validated systems . Regulatory audits and inspections: Familiarity with regulatory audit ... to provide documentation and evidence of validation activities to regulatory authorities.Clinical systems knowledge highly preferred.#EligibleforERP MRLGCTO#ONEGDMSNOTICE… more
- Novo Nordisk Inc. (Durham, NC)
- …& working relationship with stakeholders. Meet or exceed customer, business & regulatory requirements in accordance with the Novo Nordisk Way. Relationships Senior ... Manager . Essential Functions Maintain plans to meet changes in...ensure 21 CFR part 11 compliance of all computer systems Empower team to successfully execute projects & deliver… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Computerized Systems supporting GxP and Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, ... of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service Provider… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. The position will perform validation of the electronically… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Clinical Research Manager - Oncology (Remote) This role is primarily accountable for the end-to-end performance and project ... Visits Reports and escalates performance issues and training-needs to CRA manager and/or functional vendor and internal management as-needed.Performs Quality control… more
- Catalent (San Diego, CA)
- Senior Manager , Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies ... a member of the Site Leadership Team, you will partner with the General Manager to create and sustain a site culture of Safety, Quality performance, Operational… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Senior Manager , Translational Science Biostatistics will be expected to work independently with minimal ... and performing data interpretation; and supporting preparation of inputs for regulatory documents, drafting responses to health authorities including execution of… more
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. ... as briefing books, Global Investigator Brochures (GIB) and annual regulatory reportsPrepare and review marketing application submission documentsAt the Director's… more
- Merck & Co. (Durham, NC)
- …experienceGood Manufacturing Practice (GMP)-regulated manufacturing environmentElectronic manufacturing systems (eg PAS-X, SAP, Delta-V, etc.)Interacting with ... Job DescriptionThe role of Operations Manager at our Company's Durham facility is a...they must become proficient in the use of manufacturing systems and knowledgeable of site procedures in order to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview ... The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...in a manner consistent with the safety policies, quality systems , and cGMP requirements. Drive continuous improvement Other duties… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Lundbeck (White Plains, NY)
- …lead the way in creating positive customer experiences!As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand ... Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including Lundbeck policies and procedures and FDA regulations… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
