- Merck & Co. (North Wales, PA)
- …for projects of increasing complexity. Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change ... Job DescriptionUnder general supervision of an Executive Director /Senior Director , the Principal Scientist / Director is responsible for developing and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of briefing materials and meeting preparation Lead and/or support global filing activities for submissions Present regulatory strategies including ... regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Regulatory Operations Leadership Team.ResponsibilitiesProvide oversight for all Global complex submissions (NDAs, INDs, BLAs, MAAs and supplements). Lead the ... areas centered around rare diseases and immune disorders.Summary The Director , Head of Global Dossier Planning, Regulatory...and systems needed to build a core dossier for global submissions , they will liase with … 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 ... diseases and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi… 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 Lead the implementation of the quality strategy closely aligned with the business… 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 ... The Technology Management (mAb, Drug Substance, Drug Product, or New Modality) Lead is responsible for the management of technology transfer of the manufacturing… more
- Merck & Co. (Rahway, NJ)
- … Global Labeling Therapeutic Area, and under the supervision of the Global Labeling Strategic Director , the GLL is responsible for:- Developing, maintaining, ... Job DescriptionThe purpose of the Global Labeling Therapeutic Area group is to drive...standards and regulatory labeling requirements to support timely regulatory submissions for assigned products.- Leading cross-functional teams to develop,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Nordisk, you will have the opportunity to build a life-changing career in a global business environment. We encourage our employees to make the most of their talent. ... to realize your potential? The Position To support the Director of US Tax Operations in leading and managing...Finance & Operations - Finance and Supply Chain, and Global Tax based in Denmark aka Corporate Tax. Continual… 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 ... build up standard on SDTM/ADaM datasets, and TFLs.Responsibilities- Supporting project lead on outsourced projects, act as statistical programming subject matter… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune disorders.Summary The Director , Clinical Safety, will be a product safety lead or part of a product safety team, and be responsible for overall product ... 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… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global harmonization of programming processes ... submissions and approvals. Authors or initiates writing of global standard operating procedures for statistical programming practice, especially with respect… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …deliverables on time and within budget to support drug development processes and global submissions . This position provides leadership within Data Management by ... 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… 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 ... around rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, companion… 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 ... this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support...project teams for the diagnostic, in full alignment with Global Program Teams (GPT) for the therapeutic, covering all… more
- Eisai, Inc (NJ)
- …etc.With minimal supervision, preparing and/or reviewing the clinical sections of submissions documents such as briefing books, Global Investigator Brochures ... from you. Job Summary The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. As the Lead Medical Writer,… more
- Novo Nordisk (Princeton, NJ)
- …across multiple functional areas. Relationships You will report to the Senior Director , Global Regulatory Portfolio Lead . Essential Functions + ... wants to work with innovative investigational medicines. You will lead a global regulatory team to develop...and meeting preparation + Lead and/or support global filing activities for submissions + Present… more
- Amgen (Los Angeles, CA)
- …science that can turn the tide of serious, life-interrupting illnesses. **Executive Director , Global Development Lead - Xaluritamig** **Live** **What you ... are seeking an experienced, ambitious, and collaborative clinical leader to be the Global Development Lead (GDL) of xaluritamig, a novel STEAP1 targeted T-cell… more
- S&P Global (Houston, TX)
- **About the Role:** **Grade Level (for internal use):** 12 **About the Role:** Director , Relationship Manager, Global Accounts Role supports accounts on our ... global team. **The Team:** Global Major Accounts for the Americas region. Largest spending...market participants, governments, and regulators to co-create solutions that lead to progress. Vital to navigating Energy Transition, S&P… more
- Olympus Corporation of the Americas (Westborough, MA)
- …**True to Life.** **Job Description** The Executive Digital Unit Medical Director (DUMD) is a physician/surgeon with deep clinical practice knowledge, medical ... the application of prior clinical knowledge and medical training to lead internal stakeholders within the DU while simultaneously demonstrating proficiencies in… more
- Novo Nordisk (Lexington, MA)
- …of briefing materials and meeting preparation + Lead and/or support global filing activities for submissions + Present regulatory strategies including ... regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute regulatory… more
