- Aequor (Thousand Oaks, CA)
- …degree and a minimum of 2 years of hands-on experience in document management, including workflow coordination and system administration. Proficiency with Viva or ... comparable document management platforms is required. Strong background in project...management of R&D controlled documents to ensure compliance with regulatory standards and internal quality procedures. This role emphasizes… more
- HealthCare Support (Hudson, MA)
- …conditions, maintain patient databases, provide clinical support, ensure compliance with regulatory standards, and document communications to optimize patient ... safety and therapeutic outcomes Monday - Friday 8:30am - 6:30pm (between these hours) Rotating On Call Required Qualifications for the Pharmacist: Bachelor's Degree in Pharmacy Clear and Active Pharmacist license in the state of position 1+ year of experience… more
- Merck & Co. (Rahway, NJ)
- …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 ... frictionless flow of data from source systems to regulatory documentation.- Under the guidance of dCMC Leadership, the Senior Specialist, Digital CMC Data Analyst,… more
- Genmab (NJ)
- …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 ... portfolio of products. The lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be within Global … more
- Clever Care Health Plan (Huntington Beach, CA)
- …provider and facility applications for completeness and compliance with internal, regulatory , and accreditation standards. Perform and document Facility Site ... functions. Ensure all providers and facilities in the network meet regulatory and risk management criteria. Other duties as assigned. Qualifications Qualifications… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …processes across the global safety organization. The incumbent will ensure regulatory compliance, promote best practices, foster a culture of continuous improvement ... and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and procedures… more
- Synterex (Boston, MA)
- …with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory , and Program Management in leading the planning and preparation ... of high-quality clinical and regulatory documents. The medical writer may produce protocols, publications,...main point of client contact for issues spanning multiple document types Organize and proactively manage execution of content,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of ... PV Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders for impact assessment. Participates in the review and management of monthly, quarterly,… more
- Repligen (Waltham, MA)
- …supporting root cause investigations, and ensuring Repligen's supplier network meets regulatory and quality standards. This role is based in Waltham, MA, ... Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate cross-functional teams to assess and mitigate risks… more
- VIZIA Diagnostics (Alpharetta, GA)
- …in our Alpharetta Laboratory. Laboratory Quality Coordinator candidates MUST have prior Regulatory Compliance experience in CAP, or CLIA or CLEP. JOB DESCRIPTION: ... control, assurance, and improvement initiatives, and helps ensure compliance with regulatory and accreditation requirements such as CLIA, CAP, and NY Laboratory… more
- Protagonist Therapeutics (Newark, CA)
- …of APIs. Develop and execute manufacturing and supply strategies of raw materials, regulatory starting materials, and drug substances that meet global regulatory ... and qualification of impurities. Contribute to Quality and CMC-related regulatory correspondence. Maintain a current understanding of peptide and organic… more
- Merck & Co. (Rahway, NJ)
- …and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership and make ... strong relationships with internal stakeholders, including commercialization, quality, analytical, regulatory , manufacturing, and Supply Chain to facilitate effective technical… more
- City of Austin, TX (Austin, TX)
- …accuracy and compliance with generally accepted accounting principles and regulatory requirements. Oversees the City-wide coordination of year-end close, audit ... Awards (SEFA), Schedule of Expenditures of State Awards (SESA), and other regulatory required reports. Provides oversight and assistance to internal and external… more
- PEAK Technical Staffing USA (Los Angeles, CA)
- …includes Tracegains ingredient and supplier used by all non-branded business units. Keep the document library up to date, contact supplier to obtain the most up to ... ensure compliance with current food law and regulations. Partner with Purchasing, Regulatory and R&D on raw material change control. Follow department procedure and… more
- Statistics & Data Corporation (SDC) (Waltham, MA)
- …sections of clinical study reports, and participating in meetings with drug regulatory agencies as required. Support business development and project management with ... the study protocol, as needed *Write statistical analysis plans ensuring appropriate regulatory requirements and study objectives defined in the study protocol are… more
- Terns Pharmaceuticals (San Mateo, CA)
- …Officer and the legal team in fulfilling public company legal and regulatory obligations, including SEC filings, Section 16 reporting, proxy statement preparation ... Collaborate cross-functionally with Finance, Investor Relations, and HR teams to manage document workflows and ensure timely legal input. Maintain and manage the… more
- Aequor (Irvine, CA)
- …and clinical customer complaints. Perform hands-on technical investigations and document results per established procedures and timelines. Performs hands-on ... requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies pertaining to medical devices Minimum Requirements: Bachelor's Degree -… more
- City of Austin, TX (Austin, TX)
- …substations, transmission, distribution, and generation. Prepares necessary reports to regulatory agencies. Assists in providing technical and financial inputs for ... to meet North American Electric Reliability Council (NERC), Federal Energy Regulatory Commission (FERC), Electric Reliability Council of Texas (ERCOT) and Texas… more
- Lucile Packard Children's Hospital (Palo Alto, CA)
- …the gathering of support documentation for cost reports and other regulatory reports/audits. Implements policies and procedures for the preparation, maintenance and ... Records, reviews, approves and transmits financial transactions in accordance to regulatory and internal controls. Works closely with operational personnel to… more
- Slate Auto (Troy, MI)
- …resolve accounting implications, and drafting comprehensive technical whitepapers to document your findings and recommendations. In addition, you will participate ... of US GAAP to support accurate and compliant financial practices. Develop, document , and regularly update accounting policies and procedures to ensure alignment with… more
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