- Genmab (NJ)
- …integrated database specificationCDT member:Responsible for giving statistical input to overall strategy and the synopsis development in the CDTProvide ... analysis to support development decisions, submissions, and marketing needsSupport development and communication in relation to communication strategy and/or… more
- Genmab (NJ)
- …an integrated database specificationCDT member:Responsible for giving statistical input to overall strategy and the synopsis development in the CDT Provide ... to support development decisions, submissions, and marketing needs Support development and communication in relation to communication strategy and/or… more
- Merck & Co. (Boston, MA)
- …with the worldwide clinical and academic community to positively impact Research and Development (R&D) strategy for new medicines and to improve outcomes for ... leads a large investigator-initiated studies program in partnership with late-stage development teams in Medical Affairs while also supporting early-stage … more
- Merck & Co. (Upper Gwynedd, PA)
- …Affairs Compliance, Regulatory Affairs Management, Regulatory CMC, Regulatory Strategy Development , Regulatory Submissions, Technical Writing-Preferred ... the preparation and submission of CMC dossiers for all assigned development products. -Primary responsibilities include, but are not limited to:Regulatory… more
- Merck & Co. (Millsboro, DE)
- …Regulatory Affairs Management, Regulatory Compliance, Regulatory Operations, Regulatory Strategy Development , Regulatory Submissions-Preferred Skills:Job Posting ... proficient in the job role, provide USDA regulatory guidance and regulatory strategy with interdepartmental teams for pre and post license of US… more
- Merck & Co. (Rahway, NJ)
- …functions.Responsibilities Include But Are Not Limited To: Working independently through product development teams to devise a patenting strategy with the goal ... and vaccine inventions. The position will support programs in all phases of development , from discovery through development and commercialization, and allows for… more
- Eisai, Inc (Nutley, NJ)
- …including KOLs and DOLs, and emerging digital tools and platforms.Contribute to the development and execution of an omnichannel strategy for global MA/MSL ... skills, understanding clinical trial design, statistics, etc.) to supplement MSL development .Collaborate with Digital Strategy & Innovation lead on global… more
- Insmed Incorporated (San Diego, CA)
- …related to GCPs, acts as quality lead on the gene therapy clinical development team, and collaborates on other related activities performed by Clinical Operations ... all systems, processes and their outcomes comply with applicable international and national standards, regulations and guidelines.ResponsibilitiesResponsibilities (Essential Role… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a risk-based approach to ensure the Audit Plans are aligned with the company's strategy and objectives and adjust the plan as needed to support business functions, ... eQMS in a timely manner.Support CAPA completion for all outsourced audits with Development and Medical QA, PV QA, QMS and stakeholders.Collaborate with QMS Team and… more
- Eisai, Inc (Bakersfield, CA)
- …and strategies through industry and scientific acumen. Provide inputs to overall development of strategy , budget and resources including talent pool and ... through in neurology and oncology, with a strong emphasis on research and development . Our history includes the development of many innovative medicines, notably… more
- Tris Pharma (Monmouth Junction, NJ)
- …a leading privately-owned US biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, ... anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the US We also… more
- Eisai, Inc (Nutley, NJ)
- …with and addressing regulatory agencies.Experience in leading clinical operational strategy development , stakeholder management, vendor relationship management, ... and oncology, with a strong emphasis on research and development . Our history includes the development of...with the overarching project plans established by the various International Project Team Leaders (IPTLs). This role requires a… more
- Eisai, Inc (Nutley, NJ)
- …through in neurology and oncology, with a strong emphasis on research and development . Our history includes the development of many innovative medicines, notably ... Affairs strategic plan for assigned therapeutic area(s). These deliverables include development and review of compliant scientific exchange materials to be used… more
- Eisai, Inc (Nutley, NJ)
- …through in neurology and oncology, with a strong emphasis on research and development . Our history includes the development of many innovative medicines, notably ... and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management… more
- Merck & Co. (Rahway, NJ)
- …reviews and meta-analyses, and economic modelling. Key responsibilities also include development of American Managed Care Pharmacy (AMCP) dossiers for US payers, ... The incumbent is expected to work cross-functionally with clinical development , medical affairs, biostatistics, market access, commercial and country affiliates.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Implementation Services Lead plays a key role in overseeing the development , validation, implementation, and integration of GxP-regulated systems across the ... systems while ensuring alignment with the Global Digital Transformation (DX) strategy , regulatory compliance framework, and overall quality assurance standards. This… more
- Repligen (Waltham, MA)
- …and external audit schedules; serve as host for site auditsMaintain risk-based strategy for overall Quality compliance across the organization and in support of ... to implementation when required. Review and approve New Product Development Design History Files for the site. Assists with...opportunity to contribute to the healthcare of patients worldwide. All of this with an international team in Waltham,… more
- Northrop Grumman (Falls Church, VA)
- …they're making history. Northrop Grumman's Defense Systems Weapons Systems Division (WSD) International Strategy and Business Development organization is ... are strongly preferred. This position will report to the Director of International Strategy and Business Development for the Weapon Systems Division. This… more
- Lockheed Martin (Colorado Springs, CO)
- …impacting countries in the Indo\-Pacific region * Ability to direct and enable International Strategy & Business Development and Lockheed Martin Government ... **Description:** The C4ISR Global Command & Control \(GC2\) Business Development role is responsible to lead the planning and execution of new business opportunities… more
- dsm-firmenich (Princeton, NJ)
- …dsm-firmenich can differentiate + Proven track record of data-driven decision-making in strategy development and execution + International experience and ... **Director/Sr. Director, Global Strategy Development , Beverages** **Location: Princeton, NJ, US or Brussels, Belgium; Delft, Netherlands; Sharnbrook, UK** With a… more
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