- Merck & Co. (Rahway, NJ)
- …experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement experience ... date: -As soon as possible.Job Description: Seeking a full-time Business System Associate for the Labeling Operations area within the GRACS Regulatory … more
- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionGRACS CMC - Associate Principal Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director/Director/Principal Scientist/Sr Principal ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic ... products.Responsibilities: CDx development : Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for ... The lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be...and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr.… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. The Opportunity This Associate Director Regulatory Affairs - APAC will work on-site at ... in the Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs, APAC (Asia Pacific) is to combine knowledge of scientific, … more
- Kyowa Kirin North America (Princeton, NJ)
- …offices in California, North Carolina, and Mississauga, Ontario. Summary: The Associate Director, Regulatory Affairs, Advertising and Promotion Compliance will ... for an assigned product to ensure compliance with US regulatory requirements. In addition, the associate director...with US regulatory requirements. In addition, the associate director will be responsible for supporting preparation of… more
- Genmab (NJ)
- …feel like a fit? Then we would love to have you join us!Role:The Associate Director acts as a statistical expert supporting the clinical development of compounds as ... trial responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and plans.Responsibilities:Compound/Indication… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDevice Development Associate Principal Scientist - Development Strategy, Design Controls( Associate Director Equivalent) Our company's Device ... from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This position will interact… 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. (San Francisco, CA)
- …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 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
- Insmed Incorporated (San Diego, CA)
- …lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to take care of ... technical issues. Contributes to method qualification and validation according to regulatory guidelines such as ICH, FDA, and cGMP, evaluating method characteristics… more
- Merck & Co. (Omaha, NE)
- …the right time. -We are seeking a Growth and Improvement minded Associate Specialist, Logistics who can help drive our Strategic Operating Priorities.Strategic ... SummaryThe Associate Logistics Specialist will be responsible for export of...closely with freight forwarders, QA departments, USDA and other regulatory officers. Provide data to the Finance department so… more
- Merck & Co. (North Wales, PA)
- …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
- Aequor (Thousand Oaks, CA)
- …and laboratory logbooks. Preferred Qualifications ? Ability to adhere to regulatory requirements, written procedures and safety guidelines? Ability to evaluate ... documentation/data according to company and regulatory guidelines? Ability to organize work, handle multiple priorities and meet deadlines? Strong written and oral… 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)
- …process change requests and deviation reports while ensuring regulatory compliance.Education and Minimum Requirements:Bachelor's degree in engineering, chemistry ... Relationships, Lean Manufacturing, Manufacturing Processes, Manufacturing Support, Pharmaceutical Manufacturing, Regulatory Compliance, Root Cause Analysis (RCA), Stakeholder Engagement, Stakeholder… more
- Merck & Co. (Rahway, NJ)
- …as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines ,- strategies ... Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance, Risk Management, Sourcing and Procurement, Strategic Planning… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking a Warehouse Operations Associate III as part of the Technical Operations team based in Raritan, NJ. ... efficient utilization of the warehouse space. This individual will assist in regulatory inspections, perform safety and quality audits, and answer relevant questions… more
