- Aequor (San Diego, CA)
- …technologies. Experience in vendor selection, configuration, and implementation of regulatory information management systems and publishing systems. Demonstrated ... principles and change control processes. Ability to work collaboratively with Regulatory Affairs, Medical Writing, and other functions to publish regulatory … more
- Aequor (Piscataway, NJ)
- …technologies. Experience in vendor selection, configuration, and implementation of regulatory information management systems and publishing systems. Demonstrated ... principles and change control processes. Ability to work collaboratively with Regulatory Affairs, Medical Writing, and other functions to publish regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Finally, this position has advanced skills in continuous improvement, project management , change management , and risk managementResponsibilities: Leadership, ... and cleaning, database lock), to ensure data quality/integrity and regulatory complianceEnsures that Data Management Plans are...the right on a temporary or indefinite basis to change or adjust job requirements to meet business, scheduling… more
- BioAgilytix (Durham, NC)
- …technical concepts clearly and work cross-functionally to align data management goals with BioAgilytix's operational and regulatory requirementsDemonstrated ... checks, and setting up clear governance so everyone knows who can see or change each dataset. You'll start as a "player-coach," doing the technical heavy lifting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …more complex disease areas. This position requires experience in continuous improvement, project management , change management , and risk management . ... around rare diseases and immune disorders. Summar y : The Manager, Data Management is accountable for end-to-end delivery of clinical data management services… more
- Aequor (Thousand Oaks, CA)
- …managing projects, ensuring timely delivery and adherence to budgets. o Skills in change management to effectively implement new processes and technologies. o ... processes Regulatory Compliance and Quality Assurance: Ensure all data management activities comply with regulatory standards (eg, FDA, EMA, ICH-GCP).… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …is responsible for maintaining and advising new projects on the Building Management System while collaborating with the Engineering team to provide necessary ... supervision and conduct testing Core roles include communication, compliance, risk management , and use of current technology System Design and Specification… more
- Genmab (NJ)
- …developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines(R) that change lives and the future of cancer treatment and serious ... a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading… more
- Twist BioScience (South San Francisco, CA)
- …for both internal development and external services, and demonstrating ROI for MES investments. Change Management : Lead change management efforts related ... of our proprietary MES technologies will ensure strict adherence to regulatory requirements, optimize complex biological manufacturing processes, and align with our… more
- Merck & Co. (Durham, NC)
- …support in the areas of equipment and automation systems, validation, deviation management and product franchise. Specific assignments may be focused in one area ... process understanding Author, review, and/or edit technical documents to support regulatory filings including technical reports and risk assessments Author or… more
- Genmab (NJ)
- …CollaborationCollaborate with Trial Management , Clinical Operations, Medical, Biomarker Management , Biostatistics, Medical Writing, and Regulatory Affairs to ... industry data standards (eg, CDISC/CDASH).Excellent cross-functional communication and project management skills.Experience supporting regulatory filings and inspection… more
- Merck & Co. (Durham, NC)
- …IndicatedValid Driving License:NoHazardous Material(s):N/ARequired Skills:Adaptability, Applied Engineering, Change Control Management , Computer Technical ... support in the areas of equipment and automation systems, validation, deviation management and product franchise. Specific assignments may be focused in one area… more
- Merck & Co. (Durham, NC)
- …manufacturing process at the External Partner, which includes authorship of change control, management of process improvement projects, statistical analysis ... authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … change agent to promote flexibility, creativity, and accountability.Project management skills, responsiveness to issues, and demonstrated passion for creating ... Associate Director, Senior Manager, and Manager.Oversee the hiring, development, and performance management of staff in a growing operation in terms of volume/output… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …platform changes/improvements in a global manufacturing network and drive change management process from inception through regulatory approval to global site ... and deliver a process platform is robust and consistent. Portfolio management is required to implement process improvements, optimization, capacity expansion, and… more
- Merck & Co. (Rahway, NJ)
- …of clinical supplies including batch records, deviation and/or out-of-specification approval, change management approval, etc.Support the Quality Program Lead on ... Assurance Tools, Quality Auditing, Quality Control Management , Quality Management Systems (QMS), Quality Standards, Regulatory Requirements, Root Cause… more
- Genmab (NJ)
- …developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines(R) that change lives and the future of cancer treatment and serious ... the story of our science through compelling clinical and regulatory documents. You'll be at the heart of a...with writing tools such as MS Word, EndNote, document management systemsAbility to interpret and summarize tabular and graphical… more
- Novo Nordisk Inc. (San Francisco, CA)
- …SOPs and working practices Complies with all guidelines, policies, legal, regulatory , and compliance requirements Ensures effective administrative management of ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Eisai, Inc (NJ)
- …user acceptance testing, and integrations with other clinical applications through change management .Maintains the eTMF system including secure storage, ... and transformation initiative and is compliant with ICH-GCP and regulatory requirements. This role also provides direction, leadership and...and serve as a subject matter expert in TMF Management .Will include but will not be limited to the… more
- Merck & Co. (South San Francisco, CA)
- …Biology, Biochemistry. -The ability to influence scientists to adapt to positive change . -Experience with regulatory submissions and understanding of the review ... enhance document authoring processes, thereby improving efficiency and compliance in regulatory submissions.The candidate will play a key role in developing,… more
