- Insmed Incorporated (NJ)
- …submission trackers, and regulatory archives.Partner with cross-functional teams ( Regulatory Affairs, CMC, Clinical, Quality) to facilitate document ... management best practices.Contribute to process improvements and operational efficiencies in regulatory publishing and document management.Who You Are:You have a… more
- Insmed Incorporated (NJ)
- …clarity, accuracy, and consistency Lead document workflows throughout document lifecycles for regulatory documents, including creation, review, approval, ... efficiency and quality Maintain submissions and correspondence and archive regulatory files using Veeva Vault Document Management...and archive regulatory files using Veeva Vault Document Management System Who You Are:You have a Bachelor's… more
- Caris Life Sciences (Phoenix, AZ)
- …Initiation Visit meeting and offer ongoing site support. + Liaison with study sites and regulatory document team to ensure regulatory documentation is up to ... Summary** A Clinical Research Coordinator -Biorepository provides operational and regulatory support for the Caris sponsored studies and collaborative...date. + Ensures proper regulatory , legal, and financial disclosure documentation are on file… more
- Parexel (Providence, RI)
- …and industry practice + Solid aptitude for use of IT systems; Regulatory Information Management System (RIMS), electronic document management system (EDMS), ... expertise into strategic impact? We're seeking a sharp, detail-driven **Senior/Consultant, Regulatory Labeling** to join a dedicated partnership with a leading… more
- CSL Behring (King Of Prussia, PA)
- …GRL. + Actively contribute to the GRAST activities, strategy development, document reviews and competitive regulatory intelligence. Ensures on-time execution ... therapies that make a meaningful difference worldwide. **Position Description Summary:** Regulatory leaders who leverage regional regulatory experience to… more
- Powell Industries, Inc. (Houston, TX)
- …with outside vendors, consultants, and customers. * Understands and enforces regulatory document requirements. * Actively collaborates with other departments ... and organizational skills on multiple projects. * Advanced knowledge of regulatory standards (ANSI, IEEE, IEC) * Demonstrated verbal and written communication… more
- Southland Industries (Schertz, TX)
- …and installation processes to ensure compliance with contract specifications and regulatory standards. + Document and communicate inspection results. Identify ... and materials to ensure compliance with contract specifications and regulatory standards. **Position Details** + Conduct regular walk-through inspections on… more
- Tutor Perini (New York, NY)
- …materials, and processes to verify compliance with project specifications and regulatory requirements. + Document and report non-conformities; support the ... + Experienced monitoring concrete pours + Experience producing reports to document test results and project activities + Previous experience inspecting concrete… more
- Tutor Perini (New York, NY)
- …materials, and processes to verify compliance with project specifications and regulatory requirements. + Document and report non-conformities; support the ... + Experienced monitoring concrete pours + Experience producing reports to document test results and project activities + Previous experience inspecting concrete… 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Cipla (Fall River, MA)
- Job Title : QA Document Control Associate FLSA Classification : Full-Time, Professional Work Location : Fall River, MA Work Hours: General Shift: 08:30 AM - 5:00 PM ... Salary Range : $64,272 - $77,662 PURPOSE The QA Document Control Associate in a pharmaceutical environment is responsible...controlled documents to ensure compliance with GMP, GDP, and regulatory standards such as FDA 21 CFR Part 11,… more
- Merck & Co. (Rahway, NJ)
- …Preferred Experience and Skills Experience implementing or supporting automated regulatory authoring (structured content, template-driven generation, or document ... and supply. A key workstream within this initiative is the auto-generation of regulatory filing sections, enabled by a dedicated application designed to create a… more
- BeOne Medicines (Cambridge, MA)
- …on data governance and privacy requirements on clinical data per regional regulatory requirements. Test and document such utilities. Identify and propose ... including global health authorities and other public or purchased sources for regulatory analytical needs. Maintain the databases for regulatory analytical… more
- Twist BioScience (South San Francisco, CA)
- …multiple levels within all functional departments, including Quality Assurance, Regulatory Affairs, Supplier Quality, Supply Chain, Quality Control, Production, ... GMP, Biotechnology, Pharmaceuticals or another Regulated Industry.Experience in Quality Assurance/ Regulatory requirements in medical devices, IVD, EU IVDR/MDR, pharmaceuticals… more
- Integra LifeSciences (Princeton, NJ)
- …to advance patient outcomes and set new standards of care. The Sr. Manager, Document Control and Training is responsible for leading the Corporate Document ... and oversee quality and compliance improvement and remediation strategies for document and record control, change management, and training administration program.… more
- QualiTech (Chaska, MN)
- Regulatory Supervisor The following information provides an overview of the skills, qualities, and qualifications needed for this role. Quali Tech, LLC is a ... Run We are looking for a self-driven individual to fill our Regulatory Supervisor role for our food solutions division. They work functionally across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or similar frameworks.Help evaluate model performance, safety, and alignment with regulatory and ethical standards. Document findings, create presentations, and ... contribute to internal knowledge sharing.Participate in brainstorming sessions, demos, and workshops with internal stakeholder Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable… more
- Christus Health (Vidor, TX)
- …standards as promulgated by state and federal agencies, the hospital, and other regulatory entities Performs all duties in a manner that protects the confidentiality ... of patients and does not solicit or disclose any confidential information unless it is necessary in the performance of assigned job duties Performs other duties as assigned Requirements: Associate's Degree in Nursing RN License in state of employment or… more
- Curia (Springfield, MO)
- …and other duties as assigned. Key Job Responsibilities: + Coordinate site wide document control systems and processes to ensure their integrity and compliance with ... for efficiency and effectiveness. + Provides logistics support for customer and regulatory audits; + meetings; plant meetings & events. May include travel… more
- Terumo Neuro (Aliso Viejo, CA)
- …with regulatory agencies on administrative and routine matters. + Document , consolidate, and maintain verbal and written communication with the regulatory ... **13011BR** **Title:** Principal, Regulatory Affairs **Job Description:** Responsible for establishing, preparing, and leading the strategy for worldwide product… more
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