- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global ... Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible...regional point of contact for cross-functional process and procedural document related questions. The individual in this role will… more
- Eisai, Inc (NJ)
- …difference. If this is your profile, we want to hear from you. The Sr. Manager is to lead collaboration efforts with RandD IT to implement and maintain Eisai's ... TMF vision and transformation initiative and is compliant with ICH-GCP and regulatory requirements. This role also provides direction, leadership and training on the… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …use of standards. Works closely with site stakeholders on training and document needs. Relationships Reports to: according to the organizational chart. Essential ... best practices to/from other M2-US or NN teams Lead document control process across site Design & own process...Ensure that all activities comply with company and or regulatory procedures, practices and guidelines Follow all safety &… more
- Genmab (NJ)
- …integrity? At Genmab, we are seeking a passionate and experienced Senior Medical Writing Manager to help us tell the story of our science through compelling clinical ... and regulatory documents. You'll be at the heart of a...guidelines.Proficiency with writing tools such as MS Word, EndNote, document management systemsAbility to interpret and summarize tabular and… more
- Repligen (Waltham, MA)
- …tracker information, cross-functional daily communication, batch record reviews, document revisions, IOPQ qualification documentation and executionThis role will ... also provide extensive support with document writing, document revisions, and handling investigations. Must have thorough understanding of Good Documentation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence ... compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities:Reconcile the TMF document trackers generated by the CRO with the document … more
- Aequor (Seattle, WA)
- …Business HoursHybrid: (50%&plus days onsite required, days of week are flexible)Job ID: 62721Per manager , the Top 3 - 5 Must Have's a candidate should have are:Top ... proactive and independent thinker.Extensive experience with change control processes, document approvals, and the management of Standard Operating Procedures (SOPs),… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Experience with Computerized Maintenance/Metrology Management System (CMMS) systems (Blue Mountain Regulatory Asset Manager (RAM), SAP, or similar) preferred ... Lebanon, NH bioproduction facility. Relationships Reports to: Facilities and Maintenance Manager . Essential Functions Serves system administrator for the CMMS system… more
- Cepheid (Miami, FL)
- …for functioning as Lead Internal Auditor to schedule, plan, perform, and document internal audits of Cepheid's Quality Management System (QMS), providing continuous ... identify and implement improvements. This position will work with the Senior Manager Quality Systems Compliance.This position is part of the Quality department and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technical and career, of direct reports, and mentors or acts as functional manager of skip-level or ex-US staff. This position requires strong knowledge about RBQM, ... and related processes, policies, regulatory requirements and ICH guidance. This position requires excellent...interface with Integrated Data Review, Data Surveillance, targeted source document verification and targeted source data review. Lead the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.Drug Development Strategy: Provides input to ... at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight:… more
- Kratos Defense & Security Solutions, Inc. (San Jose, CA)
- Job Descriptions: Kratos Microwave, Inc., a Kratos' company, is looking for an experienced Document Control Manager to work onsite at their San Jose, CA ... time off, paid holidays, tuition reimbursement, and more. GENERAL JOB SUMMARY:The Document Control Manager is responsible for overseeing the creation,… more
- Catalent Pharma Solutions (Harmans, MD)
- The ** Manager , QA - Document Control** is responsible for the overall leadership of the document control functions within the Quality Assurance group. The ... manager will manage the life cycle of controlled documents ensuring regulatory requirements are met and leading continuous improvement initiatives. The … more
- AECOM (Sacramento, CA)
- …deliver a better world. Join us. **Job Description** **AECOM** is seeking a **Program Manager - Document Control** for one of our offices in **Sacramento, CA.** ... external regulatory requirements. **JOB RESPONSIBILITIES:** + Maintain and enforce document control processes from ** document creation to final archiving** .… more
- Amgen (Washington, DC)
- … Information Management System (eg VeevaVault) and support the department in regulatory document management activities. + Maintain regulatory SharePoint ... these credentials. **Basic Qualifications:** **Must have in depth knowledge of regulatory document management systems including content management and archival,… more
- System One (Florham Park, NJ)
- Job Title: Manager , Regulatory Operations Documentation Specialist - Contractor Location: Florham Park, New Jersey - hybrid 50% Type: Contract Compensation: $65 ... and ensuring regulatory compliance. The scope of this role includes document formatting, remediation and quality control (QC) of documentation for submissions to… more
- Takeda Pharmaceuticals (Boston, MA)
- …the following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Manager , Global Regulatory Affairs, Marketed Products **POSITION DESCRIPTION** : ... Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs, Marketed Products with...CTA, PSP, PIP, 15-day safety notifications, and rapid response document ; Submission planning and management of Regulatory … more
- Teva Pharmaceuticals (West Chester, PA)
- Manager , Regulatory Affairs Date: Jun 3, 2025 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva Pharmaceuticals Job Id: 61795 **Who we ... a difference with. **How you'll spend your day** Teva Pharmaceuticals USA Inc. seeks a Regulatory Affairs Manager in our West Chester, PA office to: + Evaluate… more
- Dana-Farber Cancer Institute (Brookline, MA)
- The Regulatory Compliance Manager at Dana-Farber is responsible for coordinating and leading regulatory compliance activities across all sites. This role is ... and providing expertise on regulatory needs throughout the organization. The Regulatory Compliance Manager works under the Director of Clinical Regulatory… more
- TD Bank (Greenville, SC)
- …colleagues dedicated to setting new industry standards The US Compliance Regulatory Inventory Governance (RIG) Office identifies regulatory changes and ... the US regulatory inventory. This role ensures compliance with regulatory requirements and effective change management. Key responsibilities of the role include:… more
