- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …oversight of the preparation, alignment and formulation of strategy for US and/or global regulatory submissions. This position ensures regulatory strategies ... Submissions: Provides oversight of the preparation, coordination or monitoring of US and/or global regulatory submissions. Advises on US and/or global … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders.Summary This role is responsible for leading and mentoring a dynamic and global Regulatory Intelligence & Policy team, through direct and indirect line ... corporate initiatives, ensuring that DS is prepared to meet new or proposed global regulatory requirements and that DS has a voice in defining new requirements.… 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 ... indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small ... 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 ... indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … interactions at a project level, and interacts with regional and global project team members, senior management, and outside vendors.ResponsibilitiesResponsible ... 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)
- …opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing Clinical ... hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and Pharmacometrics/… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical/oncology project development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA ... 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 ... centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, and analytic support… 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 ... complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans,… more
- Merck & Co. (Rahway, NJ)
- …drive revenue and productivity, thereby advancing our Company 's contribution to global medical innovation. Enterprise IT (EIT) is an essential component of the ... EIT SAP Platform Team is responsible for our Company's SAP Global Template asset, delivering enterprise-level capabilities through harmonized business processes and… more
- Merck & Co. (Rahway, NJ)
- …the network.The goal of this position is to influence site, regional and global business partners to drive prioritization of regulatory compliance, continuous ... Job DescriptionOur Company is a trusted global leader in human and veterinary medicine, dedicated...and driving improved outcomes.Demonstrated ability to successfully negotiate with regulatory agencies and senior operations leaders; escalates… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the benefit of patients and global human health. Responsibilities :Supervises a group of statisticians in Late Development Statistics.Provides biostatistical and… more
- Merck & Co. (Rahway, NJ)
- …comprehensive understanding of relevant healthcare environment matters, including policy, regulatory , and health technology.Developing a global internal network ... cancer patients globally.We are currently seeking an Oncology Competitive Intelligence Director specializing in Women's Cancers. This role is responsible for… more
- Merck & Co. (Rahway, NJ)
- …technology transfer to commercial manufacturing sites and authoring of regulatory filing submissions.Nature and Scope of Position:The role serves as ... managing budgets to align actions with strategy.Supervises 5 Directors or Senior Directors, and through them, approximately 85 scientists, people managers, chemical… more
- Insmed Incorporated (Bridgewater, NJ)
- …discipline. DABT/DACVP certification preferred.Minimum of 10 years of experience as a regulatory toxicologist (study director /monitor and/or project lead) in the ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...certification preferred.Minimum of 10 years of experience as a regulatory toxicologist (study director /monitor and/or project lead)… more
- Merck & Co. (Rahway, NJ)
- …Conference on Harmonization Good Clinical Practice (ICH GCP) and Global /Regional/Local regulatory requirements is needed.Strong communication skills requiring ... 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)
- …and related materials that pertain to training objectives for use at Senior Leadership meetings.Special Projects/Change ManagementAssist the Director in the ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (Rahway, NJ)
- Job Description Position Description: Director , Business Development Responsible for leading and executing business development and commercial activities which ... & Development Division , Human Health, and our Manufacturing Division - Senior Leaders.Executes business development and commercial activities in the evaluation and… more
