- Merck & Co. (Rahway, NJ)
- …portfolio of work, holding the team accountable to deliver on priorities. Document preparation , maintenance, and review of documentation including specifications, ... and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership and make… more
- Merck & Co. (Lower Gwynedd, PA)
- …utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings.- As the new facility will not be fully constructed and ready ... of laboratory processes and data to ensure compliance with existing regulatory regulation and departmental SOPs- Required Experience & Skills -Experience with… more
- Merck & Co. (Lower Gwynedd, PA)
- …utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. -As the AdVAnce facility will not be fully constructed and ... data. -May review data generated by others-Understand and apply regulatory /compliance/scientific requirements relative to their role-May publish and/or present… more
- Merck & Co. (Lower Gwynedd, PA)
- …utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. -As the AdVAnce facility will not be fully constructed and ... laboratory processes and data to ensure compliance with existing regulatory regulation and departmental SOPs-Required Experience & Skills-Experience with molecular… more
- Merck & Co. (North Wales, PA)
- …coaching on Company processes relating to CMC development team management, strategic document preparation , PM skills, and Team Management. -Work to ensure ... Budgeting, Project Management, Project Planning, Project Scheduling, Project Strategy, Regulatory Compliance, Results-Oriented, Risk Management, Software Project Management {+… more
- Vantage Specialty Chemicals (Warren, NJ)
- …data integrity management required. + Prior experience with SDS generation and regulatory document preparation strongly preferred. + Experience collaborating ... This role ensures the accuracy, integrity, and completeness of regulatory data to support compliant document generation...completeness of regulatory data to support compliant document generation and effective system use by end users,… more
- Danaher Corporation (Marlborough, MA)
- …our interdisciplinary team to generate standard operating procedures and templates related to regulatory document preparation and submission. + Contribute to ... Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Global Regulatory and Compliance Graduate Intern is responsible to evaluate… more
- Mount Sinai Health System (New York, NY)
- …**Electronic Binder Management:** + Assist with all aspects of clinical research regulatory compliance, including document preparation , submission and ... an opportunity to play a critical role in ensuring regulatory compliance and document management within a dynamic and fast-paced environment. The successful… more
- CSL Behring (King Of Prussia, PA)
- …**Summary** *Driving the planning and execution of internal GRAS processes for regulatory activities (eg submission, document preparation / compilation, ... developing therapies that make a meaningful difference worldwide. Could you be our next Regulatory Coordinator? The job is in our King of Prussia, PA office. This is… more
- AbbVie (North Chicago, IL)
- …21 CFR 11 global regulatory requirements & guidance associated with clinical regulatory document preparation & submissions, organization & content of ... & 3 years of document publishing industry experience in clinical or regulatory document management. Of experience required, must have at least 3 years… more
- GE Vernova (Wilmington, NC)
- …(FMEA), probabilistic risk analysis (PRA), and similar techniques. + Support nuclear regulatory certification or licensing document preparation , + Perform ... Easy5/MSC, Simulink-MATLAB/MathWorks, Mathcad/PTC, 3KeyMaster/WSC, ETAP, SKM], + Change, configuration, document and bill of material (BOM) management [e.g.; ENOVIA/Dassault-Systemes].… more
- General Dynamics Information Technology (Fort Detrick, MD)
- …media, and preparation of hard copy documents for off-site storage. Document control and archiving support includes but is not limited to the following** ... team members** **Assist the Government in electronic capture (scanning) of regulatory documents in a qualified Government-specified electronic document … more
- EMCOR Group (Norwood, MA)
- **Description** **Job Title: Document Control Specialist** **FLSA Classification: Non-Exempt** **Reports to: Director of Design & Productivity** **Date: September ... services, quality workmanship, safety practices, and reliability. Position Overview The Document Control Specialist is responsible for managing and maintaining all… more
- LA Care Health Plan (Los Angeles, CA)
- …with business units in audit universe preparation and validation. Assists in document preparation for regulatory and internal audits. Regulatory ... the guidelines and protocols to ensure readiness for all regulatory audits. This position will develop, with the assistance...the deficiencies. This position will be responsible for the regulatory obligations for each line of business and their… more
- Insight Global (Raleigh, NC)
- Job Description The Document Processing Specialist role produces documents that are compliant, error-free, and formatted based on the styles and templates ... in accordance with Client's standard operating procedures (SOPs). Inherent to the Document Processing Specialist role is an assurance of quality standards through… more
- Chiesi (Boston, MA)
- …development and implementation of Chiesi Global Rare Disease procedures for the regulatory aspects of labeling preparation , launch prep, review, approval, and ... regulatory guidance documents and initiating changes in systems to ensure regulatory compliance. Knowledge of Common Technical Document and global guidelines… more
- LSI Solutions (Victor, NY)
- …will possess strong administrative skills, including proficiency in Microsoft Office, document preparation , and organizing and maintaining a master scheduling ... + All essential functions listed above. + Locate all regulatory certificates. + Independently generate document change requests as needed. + Assist in review and… more
- Otsuka America Pharmaceutical Inc. (Oklahoma City, OK)
- …working in the pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Medtronic (North Haven, CT)
- …of US and EU regulatory requirements. + Directs or performs coordination and preparation of document packages for internal audits and inspections. + Leads or ... renewals, and annual registrations. + Direct or performs coordination and preparation of document packages for regulatory submissions from all areas of… more
- CSL Behring (King Of Prussia, PA)
- … regulatory activities as assigned, inclusive of potential to lead core document preparation (** **e.g.** **core briefing book, pediatric plans, etc.), ... product filing preparation activities (investigational, new and marketed) and health authority...GRL.** **Actively contribute to the GRAST activities, strategy development, document reviews and competitive regulatory intelligence.** **Ensures… more
