- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global ... medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of...Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory ... diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and… more
- Lundbeck (Waco, TX)
- …to stakeholders in the primary care and neurology settings. As an Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... resources. Pharmaceutical Environment/Compliance - Apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies… more
- Lundbeck (Fort Wayne, IN)
- …the way in creating positive customer experiences! As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand creation ... Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including Lundbeck policies and procedures and FDA regulations… more
- Lundbeck (Joliet, IL)
- …transform lives. Join us on our journey of growth! As a Psychiatry Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and… more
- Merck & Co. (North Wales, PA)
- …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
- Genmab (NJ)
- …compassionate, candid, and purposeful, and our business is innovative and rooted in science . We believe that being proudly authentic and determined to be our best ... Then we would love to have you join us!The Role:The Senior Statistical Manager acts as a biostatistician supporting the clinical development of compounds as compound… more
- Genmab (NJ)
- …Senior Medical Writing Manager to help us tell the story of our science through compelling clinical and regulatory documents. You'll be at the heart of ... compassionate, candid, and purposeful, and our business is innovative and rooted in science . We believe that being proudly authentic and determined to be our best… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and ... language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of… more
- BioAgilytix (San Diego, CA)
- At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver ... you enable life-changing, life-saving therapeutics to the patients who need them.The Manager II will lead scientific and operational activities in support of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and ... research areas centered around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance, GCP/Document Audits supports end-to-end audit activities… more
- Genmab (NJ)
- …compassionate, candid, and purposeful, and our business is innovative and rooted in science . We believe that being proudly authentic and determined to be our best ... we would love to have you join us!The Programming Manager supports the development of new therapies by ensuring...pre-defined in the SAP), answers to questions posed by regulatory authorities or ethics committees, answers to in-house questions… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The Senior Manager Health Care Professional Marketing will be responsible for supporting the development and ... and finance teams to ensure alignment with business objectives and regulatory requirements. Essential Functions Brand/Therapy Area Management o Support the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Enterprise Insights, Supply Chain, Procurement, Public Affairs, Public Policy, Regulatory , Legal, IT, Trade, Patient Safety and Compliance. External relationships ... seek out new ideas and put people first as we push the boundaries of science , make healthcare more accessible, and treat, prevent, and even cure diseases that affect… more
- Merck & Co. (North Wales, PA)
- …Drug Development, Ethical Standards, ICH GCP Guidelines, Life Science , Medical Writing, Motivation Management, Ophthalmology, Prioritization, Regulatory ... study materials (eg, ICF documents / amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection in alignment… more
- Genmab (NJ)
- …compassionate, candid, and purposeful, and our business is innovative and rooted in science . We believe that being proudly authentic and determined to be our best ... methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role… more
- Merck & Co. (Rahway, NJ)
- … Science , Medical Writing, Motivation Management, Prioritization, Problem Solving, Regulatory Compliance, Regulatory Documents {+ 4 more}-Preferred Skills:Job ... . , ICF documents/ amendments); Partners with the Study Manager on study deliverables. Ensuring CRF design supports data...clinical scientists. Core Skills Solid knowledge of clinical research regulatory requirements (e . g . , GCP and… 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 ... work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs.--The AVP provides leadership and direction through senior-level and… more
- Merck & Co. (Rahway, NJ)
- …Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our ... to solve problems, including strong background and experience in separations science , extensive experience with UPLC/HPLC analysis of biologics (eg SEC, RP,… more
- BioAgilytix (Durham, NC)
- At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver ... is seeking a Scientist III to serve as Bioanalytical Project Manager (BPM)/Principal Investigator (PI), overseeing all aspects of bioanalytical studies-including… more
