- Aequor (Newbury Park, CA)
- …and develop solutions. Provide Subject Matter Expertise in Veeva Vault Configuration and Regulatory Processes to a global user base. Develop and deliver training ... This will be a 100% remote role. The hiring manager confirmed they are looking for someone who works...materials and presentations to a global audience. Author/review/approve quality Regulatory Information Management… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …leaders, and strong collaborators, as we embark on shaping our future. The Position The Senior Manager - New Product Commercialization (NPC) and 5D will lead and ... plan alignment. Other internal relationships include those with Medical, Sales, Regulatory , Legal, Market Access, Global Marketing and Global… 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 ... compliance, and sound fiscal responsibility. The primary responsibilities of the Senior QA Manager include activities related to GMP (Good Manufacturing… more
- Eisai, Inc (NJ)
- …If this 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 ... system#LI-HC1#IND-123Eisai Salary Transparency Language:The base salary range for the Senior Manager , Medical Writing is from :126,300-165,800Under current… more
- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you. Senior Manager , US Alzheimer's Strategy and Lifecycle Planning Marketing will assist with ... hhc ).Represent the brand with internal and external stakeholders, including Global and Regional colleagues. Ensure appropriate strategic direction is communicated… 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 ... Senior Director, Supply Chain Position Summary: The ...and objectives related to Supply Chain activities.Work with the global and internal stakeholders to develop and optimize site… more
- Merck & Co. (Rahway, NJ)
- …for assigned protocols and sites in a country.Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country ... requirements internally and externally. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall… more
- Merck & Co. (North Wales, PA)
- …Trial Team (CTT)May work closely with the Medical Writer on clinical/scientific and regulatory documents and the Study Manager on study deliverables.May provide ... DescriptionOur Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and… 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 ... centered around rare diseases and immune disorders. Summary The Global Team Leader, is a senior , cross-functional...and leadership of clinical development plans, and addressing all regulatory , drug and patient safety, data, CMC, IP, patient… more
- Merck & Co. (North Wales, PA)
- …in the Research & Development organization at our company. Position Description/Summary The Senior Specialist, Project Manager is a core member of Early Drug ... strategies and execute our Company's drug and vaccine development efforts. The Senior Specialist is expected to provide project management leadership and drive… 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 ... strategy closely aligned with the business strategy within one or more Global Project Team(s) (GPT) within Oncology Development Franchises or Business Units. Provide… more
- Aequor (Thousand Oaks, CA)
- The Supply Chain Project Manager (SCPM) will translate product variation strategy as determined by the Variation Lead for reportable changes for Global ... fully compliant (RFT) maintenance of Change Control Management system related to Global Distribution Change Records (GDCR) and/or Customer Facing SKU Change Records… 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 ... business areas (Sales, Marketing, Clinical, TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT, Finance, HR, and Legal).ResponsibilitiesTraining… more
- Aequor (Austin, TX)
- …environment. The Capital Projects Sourcing Manager will report to the Category Senior Manager for Capital Construction and have the opportunity to work ... for signature, and store for compliance. Ideal Capital Projects Sourcing Manager candidate: 5 years hands-on capital construction experience in procurement and… more
- Novo Nordisk Inc. (Boulder, CO)
- …GMP manufacturing experience in the areas of biotechnology/pharmaceuticals. Relationships Senior Manager , Material Management. Essential Functions Manage ... analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …communication and implementation of consistent processes across various product teams and global manufacturing sitesProvide updates to Senior Management on site ... and variances that occur during production or validationWork with Quality, Manufacturing, Regulatory , and subject matter experts to prepare for FDA and other agency… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …OR rep licensure), NNI government agreements (eg Corporate Integrity Agreement (CIA)) regulatory requirements (eg PDMA reporting) and the systems that support these ... Effectiveness, Clinical Operations and Marketing Effectiveness. Strong collaborations with senior leaders from Legal, Finance, Operations and Market Access as… more
- Merck & Co. (Durham, NC)
- Job Description Job Description: The Senior Maintenance Shutdown Scheduler is a member of the Engineering, Maintenance and Site Services (EMSS) team providing ... by policies, procedures, and business plan; receives limited guidance from manager . Coordinate interactive planning sessions with site IPT's and contractors to… more
- American Honda Motor Co Inc (Marysville, OH)
- …15 years as an attorney in commercial contracts* Proven knowledge of contractual, regulatory , and commercial lawOther Job-Specific Skills* Preferred: 5 - 10 years of ... new systems, processes, or policies within Honda's North American and global environment.* Good skills in communication, presentation skills, problem solving,… more
- FastTek Global (Southfield, MI)
- Senior Global IT Manager #988086 Job Description: The Senior Global IT Manager will play a key role in helping to expand Global IT management ... updates on project progress, risks, and milestones. Ensure compliance with regulatory requirements, industry standards, and best practices in IT governance,… more
