- Merck & Co. (Rahway, NJ)
- …Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance , Regulatory Compliance , Regulatory Labeling, ... experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement experience… more
- Merck & Co. (Rahway, NJ)
- …(BLA), Electronic Common Technical Document (eCTD), Immunochemistry, International Regulatory Compliance , Microbiology, Molecular Microbiology, Pharmaceutical ... Job DescriptionGRACS CMC - Associate Principal Scientist, CMC, R4 - Pharm Pre-approval...Process Development, Regulatory Affairs Compliance , Regulatory Affairs Management, Regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... listings, SAP, Data Management plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in… more
- Merck & Co. (Rahway, NJ)
- …in West Point, PA / Rahway, NJ is seeking a curious and collaborative Associate Director to support our robust infectious disease and vaccines pipeline. - As an ... Associate Director, you will represent QP2 on cr o...vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJoin Our Team as an Associate Principal Scientist/ Associate Director in Biologics Drug Substance Commercialization!Are you ready to make a ... cross-functional teams to foster collaboration and innovation.Document Excellence: Author regulatory and technical documentation, ensuring all processes align with… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… more
- Merck & Co. (Rahway, NJ)
- …matters.Review process change requests and deviation reports while ensuring regulatory compliance .Education and Minimum Requirements:Bachelor's degree in ... Relationships, Lean Manufacturing, Manufacturing Processes, Manufacturing Support, Pharmaceutical Manufacturing, Regulatory Compliance , Root Cause Analysis (RCA), Stakeholder… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... of decision-making at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas. - This Associate… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/ Associate Director, has primary responsibility for ... reimbursement and market access, and provide input into clinical, regulatory , payer/access, marketing and evidence generation strategy and programsIn collaboration… more
- Merck & Co. (Rahway, NJ)
- …Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance , Risk Management, Sourcing and Procurement, ... as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines ,- strategies… more
- Merck & Co. (Rahway, NJ)
- …process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the ... next generation process development and characterization, process validation, and regulatory submission authoringIn this role, the successful candidate will be… more
- Merck & Co. (Rahway, NJ)
- …engagements. This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability to manage competing ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Merck & Co. (Rahway, NJ)
- …in Rahway, New Jersey.The Sterile Process Engineer role at the Associate Director level will leverage the individual's leadership, technical, and communication ... selected candidate will lead and contribute to the launch and regulatory certification of the facility, concluding startup and operational readiness activities.Once… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Pediatrics will focus on driving strategy, development, and life-cycle ... the external community (Key Scientific Leaders, Patient Community, Payers, Regulatory Agencies)Responsible for managing, coaching, and mentoring Clinical Directors… more
- Merck & Co. (Rahway, NJ)
- …for establishing a strong business partnership and ensuring excellence in Compliance , Supply, Continuous Improvement, and Cost Management.--The Associate ... - Knowledge of lean principles, equipment design, and preventative maintenance.- Regulatory - Global regulations and compliance requirements governing… 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
- Eisai, Inc (Nutley, NJ)
- …price reporting, patient support, as well as other pharmaceutical regulatory counseling. Essential Functions: Provides proactive and day-to-day legal support, ... support, patient assistance programs, adherence support).Works to ensure Eisai's compliance with pharmaceutical laws and industry guidelines including the… more
- Eisai, Inc (Nutley, NJ)
- …exchange.Maintain scientific credibility and ensure operational excellence (20%) Ensure compliance with regulatory and other ethical guidelines relevant ... your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education...to the pharmaceutical industry, and to ensure compliance with Eisai policies & standard operating procedures.Self-study to… more
- Eisai, Inc (Nutley, NJ)
- …and provide input into CME budget and website portal as needed. Ensure compliance with regulatory and other ethical guidelines relevant to the pharmaceutical ... is your profile, we want to hear from you. Associate Director, Medical Education - Oncology, is responsible for...industry, and to ensure compliance with Eisai policies & procedures.Provide support for new… more
- Kenvue (Summit, NJ)
- …Key Responsibilities: Lead and manage global package testing laboratories, ensuring compliance with regulatory and industry standards. Lead supplier (direct ... Kenvue is currently recruiting for a: Associate Director, Global Package Testing What we do...and design teams to ensure testing enables speed and compliance across early-stage prototyping to commercialization. Establish global governance… more
