- Merck & Co. (Rahway, NJ)
- …responsible for the business process and related activities associated with Global Regulatory Affairs and Clinical Safety (GRACS) Business Development Execution. ... Mergers and Acquisitions (M&A), Negotiation, Out Licensing, People Leadership, Pharmaceutical Regulatory Affairs , Pharmacovigilance, Regulatory Affairs … more
- Haleon (Warren, NJ)
- …and + identifying emerging regulatory trends and evolving FDA expectations. **The Regulatory Affairs Co -Op Associate** The objective of the Regulatory ... providing visibility to potential gaps. In this role, the Co -Op Associate will be provided with the opportunity...wide format used for submissions to the FDA. The Regulatory Affairs Co -Op will be… more
- Organon & Co. (Jersey City, NJ)
- …questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... Description** **The Position?** Reporting to the Director in Organon Regulatory CMC,?the Associate Principal Scientist is responsible for?developing and?implementing… more
- Merck & Co. (Rahway, NJ)
- …studies.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Neuropathic Pain, Neuroscience, Neuroscience Research, Pain Management, Pharmaceutical Development, Regulatory Affairs Compliance, Regulatory Compliance,… more
- Merck & Co. (Rahway, NJ)
- …--Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Management Process, Medical Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance, Regulatory Compliance {+ 5… more
- Merck & Co. (Rahway, NJ)
- …the Final Study ReportMaintain contact with all stakeholders (project leader, regulatory affairs , quality assurance etc.) and keeps them informed ... and report clinical laboratory and field studies that will support the regulatory approval of new companion animal and livestock products. The position requires… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Director May Be… more
- Merck & Co. (Rahway, NJ)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Key Functions: Specific Responsibilities Evaluating pre-clinical… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May Be… more
- Merck & Co. (Rahway, NJ)
- …and executing integrated development plans that align clinical, medical affairs , commercial, manufacturing, regulatory , analytical, and epidemiological ... design and implementation of clinical studies, familiarity with biostatistics, and/or regulatory review process is desirable Proven leadership skills with the… more
- Merck & Co. (Rahway, NJ)
- …position resides in the V&I organization, which includes Global Medical and Scientific Affairs as well as Outcomes Research.Under the guidance of a senior leader, ... incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial, and country affiliates and may… more
- Organon & Co. (Jersey City, NJ)
- …questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... Position** Reporting to the Director or Executive Director in Organon Regulatory Chemistry, Manufacturing and Controls (CMC), the Associate Principal Scientist is… more
- Organon & Co. (Jersey City, NJ)
- …collaboratively with cross-functional colleagues in preclinical science, data science, clinical operations , regulatory affairs , chemistry, manufacturing and ... 2a study protocols, in collaboration with internal (biostatistics, clinical operations ) and external (contract research organization [CRO], bioanalytical and/or… more
- Eisai, Inc (Nutley, NJ)
- …field sales resources, and media assets. This role represents a key opportunity for a talented, passionate marketer to lead important and innovative commercial ... identify opportunities for optimization Provide support to Advocacy & Government Affairs teams for early AD patient identification screening initiatives Work… more
- Merck (Rahway, NJ)
- …responsible for the business process and related activities associated with Global Regulatory Affairs and Clinical Safety (GRACS) Business Development Execution. ... Mergers and Acquisitions (M&A), Negotiation, Out Licensing, People Leadership, Pharmaceutical Regulatory Affairs , Pharmacovigilance, Regulatory Affairs … more
- Sanofi Group (Morristown, NJ)
- …opportunities, transforming concepts into business-ready solutions that future-proof Sanofi's Global Regulatory Affairs (GRA). Reporting to the Head of ... for scale. This role is ideal for an experienced regulatory affairs professional who has expanded into...to ensure smooth handoffs across the innovation funnel. + Co -create with Innovation Leads, Capability Analysts, and Process Owners… more
- J&J Family of Companies (Raritan, NJ)
- …profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... optimization and next-generation submission transformation. A key member of the ** Regulatory Operations & Digital Innovation** ( **RODI) Senior Leadership… more
- J&J Family of Companies (Raritan, NJ)
- …closely with the Global Regulatory Leader (GRL) and partners across Global Regulatory Affairs as well as Project Management, Medical Writing, Clinical and ... of a Bachelor's degree is required, preferably in Life Sciences, Business Management, Regulatory Affairs or a related discipline. Advanced degree preferred. + A… more
- Pfizer (New York, NY)
- …You Will Achieve** You will represent Pfizer as an approval liaison in the regulatory affairs team assisting with diagnostics regulatory tasks. You will ... and accomplishments. + Liaise with and provide input/direction to Clinical Trial Regulatory Operations , Clinical Diagnostics, and other key stakeholder to ensure… more
- Organon & Co. (Jersey City, NJ)
- …Position** Leading the Regulatory Policy and Intelligence activities for Global Regulatory Affairs covering all Therapeutic Areas and products, as well as ... of the world of interest to Organon. **Responsibilities** + Provide Global Regulatory Policy and Intelligence insights to the organization to guide product… more
