- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...role will need to partner closely with teams and senior leaders from across Regulatory Affairs, as… more
- 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. (Boulder, CO)
- …we are driving change. Are you ready to make a difference? The Position The Senior Manager of Specialty Raw Materials Manufacturing is responsible for ensuring a ... and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at...raw materials, during the execution of his/her duties, the Manager / Senior Manager should seek to… more
- Merck & Co. (Rahway, NJ)
- …Management within the Global Data Management & Standards (GDMS) organization, the Manager Global Data Standards - Ops and Reference Data Management is ... Job DescriptionPosition Description: Manager , Operations and Reference Data Management, Global...insights into implementation of strategic direction.In support of the Senior Director, Operations and Reference Data Management, ensures project… 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
- 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
- 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
- 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 ... of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within...in evaluating study budgetsCollect information and coordinate with DS Regulatory Operations to post trial information on required public… 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
- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- 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
- 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
- Merck & Co. (North Wales, PA)
- Job DescriptionThe drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in the Research & Division organization ... of our company.- Position Description/Summary: The GPAM Associate Director, Project Manager , is a core member of Early Drug Development and/or Late Drug Development… 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
- 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
- Merck & Co. (Millsboro, DE)
- …documentation, and other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory inspections ... team of animal care and testing specialists.Serve as a member of the Senior Leadership Team for the Millsboro, DE biologics manufacturing site.Lead numerous projects… 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
