- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional activities ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...related to US/Ex-US regulatory submissions. In addition, this individual will be responsible… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a sound, overarching and competitive, asset strategy and execution to ultimately achieve global regulatory filings and ensure wide access of the compound. That ... complex, global team in charge of a global clinical program designed to support registration...the Organization.- Accountable for all external information of the program , including publications, regulatory documents, clinical trial… more
- Merck & Co. (Rahway, NJ)
- …Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed. Performs Quality ... HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilence, Global Medical Affairs to align on key issues/decisions across the trials.… more
- Novo Nordisk Inc. (Boulder, CO)
- … global requirements Develops comprehensive, relevant resources (eg training program , FAQs) to enable compliance to change control process requirements across ... analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder,… 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 ... data services they provide to support drug development processes and global submissions.This position provides expertise within Data Management by partnering with… more
- Novo Nordisk Inc. (Boulder, CO)
- … program teams. Physical Requirements Approximately 5% travel to Global Contract Manufacturing and Vendor Sites. Qualifications Education Level: PhD with ... analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... responsible for creating and assisting in the development of compliance program trainings and communications, including developing eLearning modules. This position… more
- Eisai, Inc (NJ)
- …reviewing the clinical sections of submissions documents such as briefing books, Global Investigator Brochures (GIB) and annual regulatory reportsPrepare and ... 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)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the… more
- Eisai, Inc (Nutley, NJ)
- …to standards.Oversee regional security vendors.Prioritize risk-based reduction efforts. Manager investigations.General Compliance Activities:Maintain an inventory of ... play a pivotal role in ensuring the organization's adherence to security, regulatory , and compliance standards. Collaborating with business and EIT stakeholders, you… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary:Oversee and lead the validation program for production equipment and processes used to support manufacturing of aseptic and terminally sterilized ... completionResponsible for drafting and providing technical guidance for the validation program , Policies and SOPs and other master documentsSupport Engineering and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Corporate Compliance & Privacy Officer in setting the strategy and program requirements for the Corporate Compliance and Government Accountability Programs. The ... position is responsible for managing and operationalizing the program and team, related to the Ethics, Compliance & Privacy Department's Government Accountability … more
- Novo Nordisk Inc. (Los Angeles, CA)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Catalent (Harman, WV)
- …and eight additional suites coming online.Reporting to the Vice President and General Manager , the Senior Director Supply Chain directs all facets of supply chain ... policies, programs and objectives related to Supply Chain activities.Work with the global and internal stakeholders to develop and optimize site supply chain… more
- Merck & Co. (North Wales, PA)
- …strategy and execution of Phase 1-4 clinical studies.-Under the direction of the Program Lead, you will collaborate with global , cross- functional team-members ... trial team.Collaborates with the Medical Writer on clinical/scientific and regulatory documents.Partners with Study Manager on study deliverables.Participates… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well ... (SOPs). Ensures quality control activities are aligned with industry, regulatory and corporate practice. Exercise judgment within generally defined practices… more
- Jazz Pharmaceuticals (New York, NY)
- …as required by Jazz.Execution of all activities within the defined Jazz regulatory and compliance program .Maintain company manuals, reports, computer systems, ... apply via the Internal Career siteJazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives… more
- HSBC (New York, NY)
- …our people, our investors, our communities and the planet we all share. A Global Regulatory Policy Manager - Liquidity provides technical regulatory ... challenge and governance to mitigate regulatory risk. Global Regulatory Policy Manager -...through an industry-leading volunteerism policy, a generous matching gift program , and a comprehensive program of immersive… more
- Regeneron Pharmaceuticals (Troy, NY)
- …with cross functional teams, contract manufacturing organizations, as well as global regulatory partners. + Participates in and leads cross-functional ... Regeneron is currently looking for a Manager for our CMC Regulatory Sciences...regulatory professional responsible for overseeing CMC aspects of global submissions, with a particular focus on rest of… more
- AbbVie (Madison, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Senior Manager , Global Regulatory Strategy, US & Canada, AbbVie Inc., ... driver indications within a Therapeutic Area and support the Manager , Global Regulatory Lead (GRL),...regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program… more
