- Merck & Co. (Rahway, NJ)
- …Required experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement ... Training Programs, FDA Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance, Regulatory Compliance, … more
- Merck & Co. (Upper Gwynedd, PA)
- … regulatory issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... Job DescriptionGRACS CMC - Associate Principal Scientist, CMC, R4 - Pharm Pre-approval...Regulatory Compliance, Microbiology, Molecular Microbiology, Pharmaceutical Process Development, Regulatory Affairs Compliance, Regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... 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
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for ... & International). Eisai Salary Transparency Language:The base salary range for the Associate Director, Global Medical Affairs Training and Education is from… more
- Abbott (San Diego, CA)
- …for diversity, working mothers, female executives, and scientists. The Opportunity This position, Associate Director Regulatory Affairs , works out of our ... (NPI) team, reporting to the Director of Global NPI and US Regulatory Affairs . We're empowering smarter medical and economic decision-making to help transform… more
- ADMA BIOMANUFACTURING LLC (Boca Raton, FL)
- …then consider ADMA Biologics. We currently have an exciting opportunity available for an Associate Director, Regulatory Affairs - Plasma Services in Boca ... Raton, Florida! The Associate Director, Regulatory Affairs - Plasma Services is responsible for the regulatory compliance of the Plasma Services… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. Associate Director, Medical Education - Oncology, is responsible for the strategic planning and ... of relevant medical communications deliverables aligned with the Medical Affairs strategic plan for assigned therapeutic area(s). These deliverables include… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/ Associate Director, has primary responsibility for ... is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The incumbent… more
- Insmed Incorporated (San Diego, CA)
- …also key duties. Collaboration with R&D, Process Development, Quality Control, and Regulatory Affairs is essential, as is facilitating technology transfers and ... 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… more
- Genmab (NJ)
- … regulatory policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr. Director, Labeling, ... we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director...us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading the… more
- AUROBINDO (Durham, NC)
- …with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs . In addition to several formulations under manufacture, we ... have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.Job OverviewDedicated, knowledgeable, responsible/ reliable employee who can work in a fast-pace warehouse environment.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders ... design pull you in? Are you ready to experiment with us? The Position The Associate Director of Nephrology Key Opinion Leader Marketing will be a pivotal driver in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The Associate Director Consumer Marketing will be responsible for supporting the development and execution ... and finance teams to ensure alignment with business objectives and regulatory requirements. Essential Functions Brand/Therapy Area Management Develop and execute… more
- Merck & Co. (North Wales, PA)
- …work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs .--The AVP provides leadership and direction through senior-level ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- DermBiont (Emeryville, CA)
- …employees to do their best work. Overview: We are seeking a highly motivated Regulatory Affairs and Quality Assurance (RA/ QA) experienced professional to join ... with the highest probability of success in the clinic, defining clear regulatory strategies, and conducting efficient clinical trials. DermBiont works continually to… more
- Corporal Michael J Crescenz Department of Veterans Affairs… (Philadelphia, PA)
- …equitable patient care. Ensures compliance with accreditation and regulatory standards. Aligns nursing/clinical objectives with organizational strategic outcomes, ... mission. The NM maintains knowledge and ensures compliance with all regulatory and accreditation standards, Directives, policies, and standard operating procedures… more
- System One Holdings, LLC (Tarrytown, NY)
- …report teams. Collaboration with Signal Management , Medical Safety , Clinical , Regulatory Affairs , and Biostatistics groups. Experience in matrix team ... Job Title : Temp - Associate Director, Aggregate Reporting, GPS Type : Contract...Safety (GPS) and with functional areas (Epidemiology, Clinical Development, Regulatory Affairs , Statistics, etc.) contributing to aggregate… more
- Revolution Medicines (Redwood City, CA)
- …and experienced technology leader to join the Information Sciences (IS) team as Associate Director, Commercial & Medical Omnichannel Systems. In this role, you will ... marketing automation and orchestration platforms supporting our Commercial and Medical Affairs organizations. As a key partner to cross-functional leadership, you… more
- Nurix (San Francisco, CA)
- …These responsibilities involve working closely with Clinical Operations, Clinical Development, Medical Affairs , Regulatory Affairs , Clinical Trial Sites and ... new script to outmatch disease. Responsibilities and Duties: The Senior Manager/ Associate Director of Clinical Quality Assurance Auditor is responsible for… more
