- Jazz Pharmaceuticals (Redwood City, CA)
- … Process and Training to design a strategy to pre-empt compliance issues . Partner with GRADS Alliance Management to review metrics provided by GRADS ... management reviews are established. In partnership with GRADS Compliance Regulatory and Labeling Partner, attend and participate in after-action reviews… more
- Jazz Pharmaceuticals (San Jose, CA)
- …design a strategy to pre-empt compliance issues . Partner with GRADS Compliance Operations and GRADS Alliance Management to review metrics of vendors for ... Operations to support the build and optimization of the GRADS Compliance organization. Activities include providing management analysis and advice on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is a global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the ... all queries relating to the signal detection tool as well as troubleshoot issues and promptly identifying solution(s) to ensure compliance .Develop and deliver… more
- Merck & Co. (Rahway, NJ)
- …topicsSupport functional areas in identification and review of process questions and issues related to submission content management , quality and standards ... BE ONSITE 3 DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to understand the...at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees the management of PV ... and aggregate reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic… more
- SMBC (Jersey City, NJ)
- …SMBC's Compliance Department Americas Division ("CPAD") is seeking a Compliance Monitoring and Testing Associate . The Associate -level position ... of monitoring and testing engagements to validate the efficacy of regulatory compliance internal controls. This role will primarily support the monitoring and… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …for compliance with current regulations and cGMP standards. + Identify compliance issues and support implementation of continuous improvement initiatives. + ... records, as well as all supporting documentation. This includes ensuring compliance with Standard Operating Procedures (SOPs), equipment and instrument maintenance,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe USDA Compliance Subject Matter Expert (SME) - Associate Director, will report to the Animal Health Global Quality Compliance and Technical ... Subject Mater Expertise to ensure our company's manufacturing sites adhere to compliance standards established in 9CFR and enforced by USDA-APHIS-CVB Inspection and … more
- Merck & Co. (Rahway, NJ)
- …product technology transfer programs in both development and lifecycle management , ensuring compliance with relevant regulatory standards.Ensure robust ... Job DescriptionJob Summary: -The Associate Director of Device Technology is a key...and process validation, with a strong understanding of quality management systems and regulatory compliance .Demonstrated technical leadership… more
- Insmed Incorporated (NJ)
- …hub providers, and patient assistance programs to ensure service excellence, compliance , and alignment with Insmed's strategic goals.The Associate Director, ... for the future of science, we're in. Are you?About the Role:The Associate Director, Patient Services Partner Relations oversees key vendor partnerships that support… more
- Merck & Co. (Durham, NC)
- …Accountability, Audits Compliance , Batch Releases, Biodesign, Biostatistics, cGMP Compliance , Chemical Biology, Consulting, Corrective Action Management , GMP ... Guidelines, Immunochemistry, Management Process, Manufacturing Audits, Manufacturing Compliance , Performance Improvement Plans, Pharmaceutical Manufacturing, Pharmaceutical Quality Assurance,… more
- RWE Clean Energy (Chicago, IL)
- …of renewable energy projects, we are seeking a highly skilled and motivated **Sr** ** Associate , Asset Management ** to join our dynamic team. RWE Clean Energy's ... The Associate will also support the development, implementation, and management of production enhancement or cost savings initiatives resulting from the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …a change agent to promote flexibility, creativity, and accountability.Advanced project management skills, responsiveness to issues , and demonstrated passion for ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Associate Director, Engineering as part of the Technical Operations team based in… more
- Cipla (Central Islip, NY)
- …Opex and Services, ensuring cost-effective purchasing while maintaining quality and compliance standards. This role involves supplier management , negotiation, ... functional team to understand requirement for the procurement. Strong understanding of compliance and risk management principles in procurement and supply chain… more
- Eisai, Inc (Atlanta, GA)
- …the MSL region, including training, career evaluation, coaching, mentoring, performance management and talent review. Ensure compliance with regulatory and ... difference. If this is your profile, we want to hear from you. The Associate Director/Director, MSLs is responsible for the leadership, direction and management … more
- Cipla (Hauppauge, NY)
- …to enhance the batch review process, reduce review time, and ensure better compliance . Address any issues or concerns related to batch records raised ... of Cipla's US Subsidiaries or Affiliates. Job Title: QA Associate (Reviewer) Location: 7 Oser Avenue Hauppauge, NY (Onsite)...to ensure shop floor is maintained in state of compliance and per GMP requirement. Report, escalate to Manager… more
- Merck & Co. (Rahway, NJ)
- …internal and external stakeholders.Required Skills: Applied Engineering, Change Management , Combination Products, Compliance Packaging, Cross-Functional ... DescriptionReporting into the Director, Logistics and Distribution Technology the Associate Director, Logistics and Distribution Technology will be responsible and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …support on such items from time to time.Has sufficient knowledge to identify critical issues or problems with projects and/or identification of issues which may ... of global differences exist and understanding of the need to address such issues or concerns. Experience with IRT systems and support in managing the forecasting… more
- Novo Nordisk Inc. (Boulder, CO)
- …of both worlds to develop new medicines for patients. The Position The Associate Director of Drug Product Manufacturing is accountable for all clinical drug product ... are essential to meeting patient and business needs Rapidly and accurately communicate issues to Senior Leadership. Resolve manufacturing and facility issues to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good Clinical ... on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other vendor performance… more
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