- Merck & Co. (North Wales, PA)
- Job DescriptionPrincipal Scientist / Director, GLOBAL REGULATORY CMC Biologics (R5)Under general supervision of an Executive Director/Senior Director, the ... Document for projects of increasing complexity.Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an ad hoc ... processes for record keeping and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality… more
- Merck & Co. (North Wales, PA)
- …and medical education programsMinimum 18 months of experience in US and ex-US Regulatory , Compliance and Risk Management aspects and ability to lead contracting ... Job DescriptionRole Summary The Senior Specialist Global Professional Engagement is a member of the...an annual plan of programs that considers status of product life cycles, as well as the business goals… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …outcomes, identify market opportunities, address regulatory requirements, and shape product development strategies Regulatory Compliance : Ensure early ... This role may also serve as a liaison with global teams. This role will have Product ...regulatory guidelines and industry standards, working closely with regulatory affairs teams to address any compliance -related… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are currently recruiting for Global Oncology Marketing Director, Prostate Cancer . Our Marketing team is passionate about bringing our medicines ... require outstanding leadership in market assessment, disease state strategy, product strategy, market development, forecasting, and stakeholder management. Primary… more
- Merck & Co. (North Wales, PA)
- …Digital Marketing and Content Management Strategies with demonstrated success in building global product teams that can develop, enhance, maintain, deploy, and ... modern operating excellence.-The IT Director of the Content & Promotional Lifecycle Automation Product Line is a key leadership role in the Customer Engagement &… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …audits and independent audits; manage audit responses and observation resolution.Drive site compliance to regulatory , enterprise, and global requirements ... Company InformationLegend Biotech is a global biotechnology company dedicated to treating, and one... Compliance - Lead Auditor CAR-T is responsible for regulatory compliance supporting the production of autologous… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member and independently provides strategic ... new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety...milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …MDR and relevant vendors. Internal stakeholders: Global Safety, QPPV office, Global Development, Product Supply, Regulatory Affairs (NNI/NNCI) marketing, ... processes and activities are compliant with NAO regulations and NAO regulatory authority and inspectors' expectations; Ensure compliance with applicable… more
- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Program Leadership and Technical ... performance of team members, fostering a collaborative and innovative team environment. Regulatory Compliance and Quality Assurance:Ensure that all activities are… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …accordance with 21CFR part 58 (Good Laboratory Practice (GLP), and other global regulatory authority requirements, and industry best practices.Ensure /support ... Health Authorities in the GxP area; profound understanding of the science of product development.Must have experience within a global pharmaceutical company with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the development of internal procedures to ensure adherence to the implementation of global and harmonized Quality Standards and regulatory requirements for GMP ... Annual Product Review as per internal procedures and current regulatory requirements tracking all the complaints, deviations and change control related with… more
- Merck & Co. (Rahway, NJ)
- …software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product development to ... Job DescriptionOur company is a global health care leader with a diversified portfolio...technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …critical role in partnering with other NNI teams to drive health systems strategy Regulatory and Compliance Alignment: Ensure that all aspects of the diagnostic ... closely with cross-functional teams, including therapy area marketing teams, global commercial team (cardio renal and emerging therapy area),...and precision health strategy align with regulatory requirements and compliance standards.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Strategy, Insights and Analytics, IT, Data Strategy, Commercial Excellence, Legal, Compliance , Privacy, Regulatory Affairs, and other relevant NNI departments ... with broader TA and asset plans Work collaboratively with medical, market access, regulatory , legal, compliance , privacy and public affairs functions to support… more
- Merck & Co. (Rahway, NJ)
- …areas of focus include (1) the assurance of deliverable quality and process compliance , (2) effective deliverable development utilizing global and TA standards ... using global and TA standards and according to quality, compliance and timeliness requirements.-Expertise in SAS and clinical trial programming including data… more
- Daiichi Sankyo, Inc. (Bernards, 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 ... compound and multi-compound level deliverables. Lead the development of global harmonization of programming processes supporting global … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Bernards, 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 ... of Daiichi Sankyo (DS) in the US, EU, Japan, and other global sites. These business functions include: Clinical Operations, Clinical Development, Biostatistics and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …process changes/improvement.Partner with all stakeholders to implement process improvements.Assure regulatory compliance and technical feasibility of proposed ... Company InformationLegend Biotech is a global biotechnology company dedicated to treating, and one...help identify true root cause of investigations and assess product quality impact. This individual will provide technical support… more
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