- Merck & Co. (Millsboro, DE)
- …Process Improvements, Project Management, Regulatory Affairs Compliance , Regulatory Affairs Management, Regulatory Compliance , Regulatory ... 10%Flexible Work Arrangements:HybridShift:Not IndicatedValid Driving License:NoHazardous Material(s):N/ARequired Skills:Adaptability, Audits Compliance , Communication, Detail-Oriented, Drug Regulatory Affairs, Employee… more
- Merck & Co. (Rahway, NJ)
- …and effective implementation and oversight model to maintain best in industry regulatory compliance .The Vice President Regulatory Affairs, General Medicine ... activities in the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to… more
- Merck & Co. (Upper Gwynedd, PA)
- …(BLA), Electronic Common Technical Document (eCTD), Immunochemistry, International Regulatory Compliance , Microbiology, Molecular Microbiology, Pharmaceutical ... Process Development, Regulatory Affairs Compliance , Regulatory Affairs Management, Regulatory CMC, Regulatory Strategy Development, Regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This ... electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards.… more
- Merck & Co. (Rahway, NJ)
- …Process Improvements, Project Information Management, Project Management, Project Planning, Regulatory Compliance , SAS Macros, Social Collaboration, Software ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Twist BioScience (South San Francisco, CA)
- …continuous improvement, technical excellence, robust software development practices, and regulatory compliance .Software Development & Implementation: Oversee the ... Sr . Director, Manufacturing Execution System (MES) (Hybrid in...our proprietary MES technologies will ensure strict adherence to regulatory requirements, optimize complex biological manufacturing processes, and align… more
- Merck & Co. (Rahway, NJ)
- …Guidelines, Life Science, Medical Writing, Motivation Management, Prioritization, Problem Solving, Regulatory Compliance , Regulatory Documents {+ 4 ... clinical scientists. Core Skills Solid knowledge of clinical research regulatory requirements (e . g . , GCP and...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (North Wales, PA)
- …Risks, Life Science, Medical Writing, Motivation Management, Prioritization, Project Management, Regulatory Compliance , Regulatory Documents, Science {+ 4 ... specific partners and/or vendors.Core Skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing… more
- Eisai, Inc (Phoenix, AZ)
- …approved promotional clinical trials, patient access to medication, and regulatory / compliance guidelines preferred.Experience with account planning and ... If this is your profile, we want to hear from you. The Senior Oncology Sales Specialist is responsible for meeting/exceeding sales goals through promoting Oncology… more
- Merck & Co. (Rahway, NJ)
- …Mentorship, Neuroanatomy, Pharmaceutical Development, Pharmacovigilance, Psychiatry, Regulatory Affairs Compliance , Regulatory Compliance , Regulatory ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing… more
- Formation Bio (New York, NY)
- …early development through commercialization. You will oversee internal and external teams, ensure regulatory compliance , and play a key role in scaling our ... development, formulation, analytical methods, and technology transfer to manufacturing sites. Regulatory Compliance & Submissions Ensure all CMC activities… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Merck & Co. (Rahway, NJ)
- …Plant Maintenance, Preventative Maintenance Programs, Process Control Systems, Project Management, Regulatory Compliance , Regulatory Requirements {+ 3 ... NJ Site.Develop, implement, and maintain HVAC operational strategies that ensure compliance with GxP (as applicable) and other regulatory requirements.Lead… more
- Merck & Co. (Durham, NC)
- Job DescriptionJoin our dynamic Engineering, Maintenance, & Utility Department as a Senior Specialist, where you will play a crucial role in enhancing asset ... leadership skills to empower teams, solve complex technical challenges, and ensure compliance with industry standards while making a tangible impact on our… more
- Merck & Co. (Durham, NC)
- …Multi-Management, People Leadership, Physical Sciences, Production Management, Project Management, Regulatory Compliance {+ 2 more}-Preferred Skills:Job Posting ... North Carolina.- The Durham EHS Lead influences site leadership ensuring compliance with regulatory requirements, corporate standards, policies, and procedures… more
- Merck & Co. (North Wales, PA)
- …Guidelines, Life Science, Medical Writing, Motivation Management, Ophthalmology, Prioritization, Regulatory Compliance , Regulatory Documents, Rheumatology, ... engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …Will utilize prior industry experience to optimize resource allocation, ensure regulatory compliance , and uphold rigorous scientific standards. Understanding ... Oversight: Uphold the highest standards of quality and compliance with all regulatory bodies to include...attained. Requires a minimum of 5 years of demonstrated senior managerial experience leading large and diverse teams performing… more
- Merck & Co. (Rahway, NJ)
- …controls approach within Device Development and with external suppliers.Understand and apply regulatory / compliance requirements relative to design controls and ... from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This position will interact… more
- Aequor (Thousand Oaks, CA)
- …of DP technical process, manufacturing operations, scientific method, basic regulatory compliance expectations, and quantitative / analytical troubleshooting ... senior leadership team. Additional Responsibilities include: Engaging with Quality and Regulatory teams to ensure alignment and compliance across the network… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …actionable marketing strategies to guide customer experiences Strong understanding of regulatory , compliance , and ethical considerations in engaging with ... consistency with brand/therapy area vision and message. Relationships Reports to Senior Director of Cardio Renal Marketing Responsible for providing interface with… more
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