- Daiichi Sankyo, Inc. (Bernards, NJ)
- …industry, with involvement in regulated clinical trials, clinical safety, pharmacovigilance included regulatory document reviewMust have at least 4 or more years ... other research areas centered around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance, GCP/ Document Audits supports end-to-end audit… more
- 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …the disposition of API materials to ensure conformance to appropriate regulatory and company requirements for clinical supply manufacture and/or regulatory ... our Company procedures.- The Senior Specialist will become knowledgeable in regulatory requirements, cGMPs and our company's procedures to assure API manufacturing… 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, ... and will report to the Senior Manager of Supplier Quality.Responsibilities Supplier Performance Monitoring and ReportingCollect, analyze, and report on monthly… 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
- 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
- Integra LifeSciences (Princeton, NJ)
- …pathways to advance patient outcomes and set new standards of care. The Sr. Manager , Document Control and Training is responsible for leading the Corporate ... Document Control and Training team and is the Enterprise...Pharmaceutical and Medical Device Agency (PMDA), and other applicable regulatory agencies. To perform this job successfully, an individual… more
- Sumitomo Pharma (Lincoln, NE)
- …a dynamic, highly motivated, and experienced individual for the position of Senior Manager , Regulatory Operations, For assigned projects, the Senior Manager ... submission publishing standards and procedures, including computer word processing, electronic document management systems, and regulatory publishing software. +… more
- Abbott (Maple Grove, MN)
- …diabetes from routine fingersticks. **The Opportunity** We are looking for our next ** Regulatory Operations Compliance Manager ** to join our team on-site out of ... Maple Grove, or St. Paul, MN locations. This Compliance Manager , Global Regulatory Operations would be structured...+ Create supplemental training materials + Review and follow document quality system structure + Lead team meetings and… 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
- Teva Pharmaceuticals (West Chester, PA)
- …role will lead multidisciplinary Product Submission Teams where they will manage regulatory document planning, establish dossier timelines, identify and expedite ... Director, Regulatory Affairs - Dossier Project Manager ...in a matrixed cross functional project team and global regulatory team environment * Proficiency in electronic Document… more
- Bank of America (New York, NY)
- Global Payments Solutions - Audit and Regulatory Business Control Manager New York, New York;Chicago, Illinois; Charlotte, North Carolina; Atlanta, Georgia **To ... be at least 18 years of age.** Acknowledge (https://ghr.wd1.myworkdayjobs.com/Lateral-US/job/New-York/Global-Payments-Solutions Audit-and- Regulatory -Business-Control- Manager \_25029267) **Job Description:** At Bank of America,… more
- JPMorgan Chase (Plano, TX)
- …meaningful impact by delivering high-quality products that resonate with clients. As a Product Manager in Employee Document Services, you are an integral part of ... cross-functional teams to deliver high-quality products that exceed customer expectations. Document and Business Solutions aims to deliver a technology first suite… more
- Kelly Services (Winston Salem, NC)
- **Job Title: Manager , Regulatory CMC (Contractor)** **Hourly Pay Rate: $62.50** **Schedule: Monday-Friday, 9:00 AM-5:00 PM (Must work Eastern Time hours)** ... Summary:** An advanced therapy biotech organization is seeking a ** Manager , Regulatory CMC (Contractor)** to provide specialized...attention to detail. + Proficient in Microsoft Office and document management systems. + Must be able to work… more
- Rise Baking Company (York, PA)
- …compliance guides, inspection reports, journals, meetings, etc. + Assist the Senior Regulatory Compliance Manager with sustainability customer requests such as ... data is current and accurate + Manage data and document compilation for the development of individual product specification...palm oil and cocoa surveys + Assist Senior Regulatory Compliance Manager with sustainability directives involving… more
- CVS Health (Phoenix, AZ)
- …and every day. Oversees the day-to-day management and leadership of the plan document drafting team. Develops and coaches the team to effectively manage client ... a consistently high-quality client experience within the department while maintaining regulatory compliance. This role directly manages 10-12 colleagues and provides… more
- Amazon (Sunnyvale, CA)
- Description As Manager of Regulatory Compliance Engineering, you will lead a team of individual contributors and technical leads responsible for ensuring ... regulatory compliance across Amazon's growing portfolio of products. You...scheme and the processes required to specify, test, qualify, document and maintain certifications related to EMI, EMC and… more
