- Creative Financial Staffing (Columbus, OH)
- …Accounting ManagerHybrid schedule in downtown ColumbusPosition Summary:The Senior Accounting Manager will lead all day-to-day finance operations and supervise the ... development as needed. Through program administration and coordination, the Senior Accounting Manager will ensure that the organization has the financial systems and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Supervise designated personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. Develop ... FDA meetings (pre-IND, EOP 2, pre-NDA, pre-BLA) for review by Project Leaders Write Regulatory documents translating team strategy into regulatory overview … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …reviews and authoring reports and co-authoring primary and secondary sections of regulatory documents . The Manager , Clinical Pharmacology is expected ... setting, to drive the development of potential products and drug candidates. The Manager , Clinical Pharmacology will support or take the lead on generation of study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …DSUR, IND/NDA/BLA annual reports, BTD request etc.)Develop less complex Module 1 regulatory documents (eg cover letter, FDA forms, administrative information, ... areas centered around rare diseases and immune disorders. Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) provides planning… more
- Insmed Incorporated (Bridgewater, NJ)
- …checks and coordinate comment resolution with publishing team.Support authors to complete regulatory documents such that all components are provided and ... Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional activities… more
- Aequor (Newbury Park, CA)
- …training materials and presentations to a global audience. Author/review/approve quality Regulatory Information Management & Systems documents Analysis of the ... This will be a 100% remote role. The hiring manager confirmed they are looking for someone who works...implementation of Veeva Vault, IDMP, EU CTR, and other regulatory initiatives. Work with stakeholders to gather requirements and… more
- Medasource (Columbus, OH)
- …contrast under the direction and supervision of a licensed practitioner. Documents this information on the MAR.* Represents the departments customer service ... procedure based on clinical questions and symptoms.* Assists the Radiography/Fluoroscopy Manager in collecting and monitoring QA projects within the section.*… more
- Catalent (San Diego, CA)
- Senior Manager , Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies ... a member of the Site Leadership Team, you will partner with the General Manager to create and sustain a site culture of Safety, Quality performance, Operational… more
- Merck & Co. (Rahway, NJ)
- …bring: the satisfaction of helping to save lives.The SAP Platform Technical Project Manager role will be responsible for managing the ERP (SAP "COMET") delivery ... including project planning and system build for assigned projects.- The project manager will ensure that individual plans are built in accordance with the… more
- Aequor (Austin, TX)
- …for signature, and store for compliance. Ideal Capital Projects Sourcing Manager candidate: 5 years hands-on capital construction experience in procurement and ... contracting negotiations and execution. is searching for a Capital Projects Sourcing Manager , who will be responsible for helping execute the sourcing processes… more
- Novo Nordisk Inc. (Durham, NC)
- …on IT plans, projects & efficiencies. Meet or exceed customer, business & regulatory requirements in accordance with the Novo Nordisk Way. Relationships Senior ... Manager . Essential Functions Manage and guide team to maintain...for cGMP compliance, to include ensuring internal and external regulatory compliance of all site systems Ensure IT systems… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. The position will perform validation of the electronically… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …cataloging, archiving, metadata tagging, content management systems, etc. in Adobe Experience Manager (AEM) DAM. The DAM Librarian plays a vital role in the ... multiple NNI internal functions such as Brand Managers, Omnichannel teams, IT, Regulatory and Commercial Insights & Analytic, as well as external operational vendors… more
- Eisai, Inc (Nutley, NJ)
- …and performing data interpretation; and supporting preparation of inputs for regulatory documents , drafting responses to health authorities including execution ... want to hear from you. Job Summary The Senior Manager , Translational Science Biostatistics will be expected to work...Regulatory interaction - supports preparation of inputs for regulatory documents and helps to prepare for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …collaborators, as we embark on shaping our future. The Position The Senior Manager - New Product Commercialization (NPC) and 5D will lead and execute strategic ... Novo Nordisk Inc (NNI) cross-functional teams and executive management. The Sr. Manager will also execute the development of strategy and marketing plans for… more
- Eisai, Inc (NJ)
- …industry OR equivalent combination of education and experienceExperience writing/reviewing clinical regulatory documents and submissions for own area of study/ ... is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …is filed/archived according to applicable Daiichi Sankyo and regulatory requirements.Functional Expertise:Reviews/approves clinical study related documents ... this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience working on Phase I-IV studies… more
- Novo Nordisk Inc. (Durham, NC)
- …the stability portfolio for all products, and writing and maintaining regulatory documentation. Relationships Director. Essential Functions Lead, drive & coach teams ... with LCM department, MDEV DK & all other relevant stakeholders Ensure department documents are current & standardized Support training & development of LCM personnel… more
- Merck & Co. (Durham, NC)
- …of inclusion, feedback and empowerment.Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry.Ability to read ... and understand technical documents , drawings and specifications.Proficiency using standard software including MS Excel, MS Word, etc.Willing to work irregular hours… more
- Novo Nordisk Inc. (Durham, NC)
- …& working relationship with stakeholders. Meet or exceed customer, business & regulatory requirements in accordance with the Novo Nordisk Way. Relationships Senior ... Manager . Essential Functions Maintain plans to meet changes in...& all other relevant stakeholders Responsible for ensuring department documents are current & standardized Define user requirements &… more
