- Eisai, Inc (Nutley, NJ)
- …of staff. Determining timelines and budgets for program activities and report accordingly. Lead and participate in global regulatory initiatives and ... cycle management of existing products. May serve as the lead regulatory representative on the project team...Salary Transparency Language:The base salary range for the Executive Director , Global Regulatory Affairs -… more
- Merck & Co. (Upper Gwynedd, PA)
- …of the probability of regulatory success together with risk mitigation measures.- Lead development and execution of global product and project regulatory ... strategy(ies) by ensuring robust assessment of global regulatory CMC requirements and critical evaluation of supporting documentation to confirm acceptability… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Strategy : Align strategy with lead CDx RA representative(s) and represent Global CDx Regulatory position and provide input and updates within internal ... device company HA meetings as appropriateIn collaboration with therapeutic Regulatory leads and CDx lead develop key...Policy and Intelligence : Keep abreast of the changing global regulatory environment for devices and share/educate… more
- Eisai, Inc (Nutley, NJ)
- …reports, education, and needs.Essential Functions Advance Medical and Scientific Knowledge of the Global Medical Team (45%) Lead Global MSL continuing ... profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and...to supplement MSL development.Collaborate with Digital Strategy & Innovation lead on global MSL insights sharing forums.… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop ... Job DescriptionOur Company is a global health care leader with a diversified portfolio...manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … Knowledge: Deep understanding of FDA, EMA, and other global regulatory requirements for pharmaceutical manufacturing.Operational Excellence: Expertise ... Legend Biotech is a global biotechnology company dedicated to treating, and one...controls, and maintain permanent inspection readiness and actively support regulatory inspections. Lead facility operating review meetings and… more
- Twist BioScience (South San Francisco, CA)
- Twist Bioscience is seeking a visionary and results-oriented leader to lead our global marketing efforts and drive sustainable growth. The Sr Director , ... Marketing is responsible for leading all aspects of Twist's global marketing activities. This person will plan, develop and...launching new products; and interfacing with customers. The Sr Director , Marketing also will lead growth marketing,… more
- Genmab (NJ)
- …a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for ... lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be...policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report… more
- Merck & Co. (Rahway, NJ)
- …with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers and technical staff to support ... Job DescriptionJob Summary: -The Director , Combination Product Commercialization is a key leadership... global and site-specific projects, facilitate technology transfer, and drive… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Technical Lead , you will report into Director , Chemical Technical Operations, External Manufacturing API Technology, and play a pivotal role ... matters.Review process change requests and deviation reports while ensuring regulatory compliance.Education and Minimum Requirements:Bachelor's degree in engineering, chemistry… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and best practices for GxP systems while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall ... 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
- Insmed Incorporated (San Diego, CA)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... a Receiving Unit (internal or external QC). May act as a program lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole Summary Under the guidance of an Executive Director , has primary responsibility for developing value evidence strategies, and planning/managing ... and health systems globally. The ability to participate and lead cross-functional teams is a critical part of this...Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers for use by local subsidiaries in… more
- Merck & Co. (San Francisco, CA)
- …other pharmacometric analyses- Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, ... PKPD Modeling, Population Pharmacokinetics, R-Studio, TeamworkPreferred Skills:Drug Discovery Process, Global Regulatory , Machine Learning, Multidisciplinary Collaboration, Multiple… more
- Eisai, Inc (Nutley, NJ)
- …management.Demonstrated track record as Study Director (or equivalent role) with Global Clinical Lead or Clinical Program Director accountability. Proven ... profile, we want to hear from you. The Executive Director , Global Clinical Development resides within the...Development resides within the Oncology at Eisai. This Executive Director will lead franchise programs, and will… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full Company's ... and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings...GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate… more
- Genmab (NJ)
- …and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions ... would love to have you join us!The RoleThe Associate Director acts as a statistical expert supporting the clinical...the clinical development of compounds as compound and/or indication lead for both early and late-stage programs, and/or as… more
- Merck & Co. (North Wales, PA)
- …to demonstrate your advanced leadership and technical skills as part of a global , cross-functional team. You will build and coach your team in the development ... conduct of clinical trial(s).Serves as the Clinical Trial Team lead . Leads and directs teams in key study planning,...This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability to… more
- Twist BioScience (South San Francisco, CA)
- …are seeking an experienced and highly motivated Manufacturing Execution System (MES) Director to lead the strategic development, implementation, and optimization ... processes, and align with our overall manufacturing strategy and business objectives. The Director will lead a team of MES professionals, primarily software… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. The Director , HCP Marketing, Alzheimer's Disease will lead several core marketing, strategy, and ... This role represents a key opportunity for a talented, passionate marketer to lead important and innovative commercial work streams for a highly visible AD… more
