- Formation Bio (New York, NY)
- …Affairs lead is responsible for developing and directing the regional regulatory strategy , objectives, policies, and programs pertaining to developing and ... marketing Formation Bio's assets. This role includes the lead regulatory responsibility for support of global...registration and life cycle support and the leadership of regulatory strategy for projects that are currently… more
- Merck & Co. (Rahway, NJ)
- … precedence and competitive intelligence to facilitate development of regulatory strategy .- Assist the global regulatory lead in authoring of ... collaboration skills and will work closely with a global regulatory lead (s) to help develop and implement...all aspects of planning and implementation of a global regulatory strategy and regulatory submissions… more
- Merck & Co. (Rahway, NJ)
- …Affairs, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance , Regulatory Affairs Management, Regulatory Compliance , Regulatory ... to define and implement user requirements, workflows, and metadata standards. Ensure compliance with global regulatory standards and internal SOPs for electronic… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director and Global Lead , Patient Advocacy & Strategic Alliances position resides in the Value & Implementation (V&I) organization, ... Affairs as well as Outcomes Research. This position executes the patient engagement strategy in alignment with our company priorities. This leader is innovative and… more
- Formation Bio (New York, NY)
- …of Quality Assurance are to develop and implement a comprehensive quality assurance strategy that ensures compliance with regulatory requirements and ... you will establish and manage the organization to ensure our organization's compliance with the highest standards, including Good Manufacturing Practices (GMP), Good… more
- Merck & Co. (Rahway, NJ)
- … regulatory , quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device Development & ... Responsibilities: Lead and set direction for the device development strategy for multiple drug-device combination product development programs ranging from… more
- Merck & Co. (Rahway, NJ)
- …executive level and build cross-functional partnerships.Solid understanding of security, compliance and regulatory requirements relevant to payments (PCI-DSS) ... Job DescriptionWe are seeking a seasoned IT SAP Finance Director to lead the design, delivery and continuous improvement of SAP Finance solutions across our… more
- Formation Bio (New York, NY)
- …clinical programs across various therapeutic areas and phases (I-IV), ensuring compliance with global regulations, delivering on timelines and budgets, and driving ... clinical trials comply with ICH-GCP, FDA regulations, and other applicable regulatory standards. Champion proactive risk management by identifying and mitigating… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …per TA. Partners compliantly with respective home office functions, including Commercial Strategy and Marketing, Insights & Analytics, privacy, compliance and ... center, powered by insight and foresight. We develop an end-to-end approach to strategy , focusing on every touchpoint that impacts our customers. We leverage data… more
- Lundbeck (Staten Island, NY)
- …issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/ Compliance - Apply knowledge of pharmaceutical and regulatory ... in the primary care and neurology settings. As an Account Manager, you lead the promotion of our psychiatry portfolio, executing sales and marketing strategies with… more
- Merck & Co. (Rahway, NJ)
- …experience-driven omnichannel engine across our US Animal Health portfolio. You will lead a team that owns digital demand creation and customer experience for ... may include, but are not limited to: -- Strategic Planning Communications: Lead the development and implementation of digital marketing plans to achieve business… more
- Merck & Co. (Rahway, NJ)
- …for delivering a fully integrated stage-appropriate CMC development and commercialization strategy which yields the target commercial product.-The specific role will ... DCT deliverables including - robust processes & analytics, an integrated control strategy , successful tech transfer packages, filing and approval, and a robust… more
- Merck & Co. (Rahway, NJ)
- …in cell culture commercialization and manufacturing operations- Strong understanding of regulatory requirements- Ability to lead without authority, build trust, ... be instrumental in supporting DS commercialization, process characterization, control strategy development, tech transfer to internal and external manufacturing… more
- Merck & Co. (Rahway, NJ)
- …Expertise in cell culture commercialization and manufacturing operations Understanding of regulatory requirements Ability to lead without authority, build trust, ... be instrumental in supporting DS commercialization, process characterization, control strategy development, tech transfer to internal and external manufacturing… more
- Merck & Co. (Rahway, NJ)
- …and stakeholder engagement for our Company communications teams. Key Responsibilities Product Strategy & Roadmap Lead and manage IT applications supporting ... and communications stakeholders to refine, scope, and deliver technology solutions. Regulatory & Compliance Ensure technology solutions for communications comply… more
- Merck & Co. (Rahway, NJ)
- … Lead will drive/execute the patient engagement and advocacy strategy in alignment with company priorities, work cross-functionally with various internal ... Job DescriptionRole SummaryThe Director Scientific Patient Engagement Lead is responsible for developing and implementing a global headquarters strategic patient… more
- Merck & Co. (Rahway, NJ)
- …point in the drug development process, working closely with scientific, regulatory , statistical, and modelling colleagues across the organization to translate the ... biomarker platforms.Development and execution of the early clinical development strategy for novel therapy/Immunology programs from Preclinical Candidate approval… more
- Merck & Co. (Rahway, NJ)
- …drug substance and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support ... strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible providing Center of Excellence… more
- Merck & Co. (Rahway, NJ)
- …priorities, and manage expectations.Work hand-in-hand with the Product Technical Lead to plan sprints and ship solutions.Work cross-functionally to ensure ... regulatory complianceEnsure completeness of system documentationManage escalations, risks and dependenciesHelp define future strategy for LIMS… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Reimbursement), HEOR, Marketing, Commercial Sales, Medical Affairs, and Legal & Compliance . External relationships include Customers as outlined in the Purpose of ... of the activities described below Drive Formulary Placement For NNI Products Independent lead within NNI to develop RFP response for the targeted customers, manages… more
