- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Commissioning and Qualification Project Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position ... systems within cell therapy manufacturing. The Commissioning and Qualification Project Manager will develop and manage all aspects of the qualification program… 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 ... protocol deviations and is a key driver for inspection readiness, regulatory compliance, and successful data submissions.The Associate Director will lead… 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
- Tris Pharma (Monmouth Junction, NJ)
- …products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.Our science and technology make us unique, ... Monmouth Junction, New Jersey, Tris has an immediate opening for a SR. Manager or Manager , Quality Management Systems (QMS). Title commensurate with… more
- Merck & Co. (Boston, MA)
- …team in R&D IT brings together product management, engineering, and data science expertise. We enable data, technology and services that accelerate our scientists' ... more productive and enable innovation.We are seeking a motivated and talented Product Manager to join the RaDS Product organization. The position will report to… 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 ... fit? Then we would love to have you join us!Overview: The Programming Manager supports the development of new therapies by ensuring integrity, consistency and… more
- Lundbeck (Oakbrook, KY)
- …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 (Fort Wayne, IN)
- …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
- 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 ... (ISS) for oncology submission compounds, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) annotation… more
- Lundbeck (Memphis, TN)
- …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 (Oakland, CA)
- …lives. Join us on our journey of growth! As a Neuroscience Account Manager , you lead the promotion of our psychiatry portfolio to Psychiatrist and Institutional ... Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and… more
- Merck & Co. (Durham, NC)
- …Carolina facility is seeking to hire an experienced and technically proficient people manager to lead a team of Validation engineers. This leader will collaborate ... on the customer. Author, review, and/or edit technical documents to support regulatory filings Author and approve validation procedures in accordance with our… 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 ... delivery of laboratory data for clinical trials, clinical development, and regulatory submissions. This position develops and proposes strategies for laboratory data… more
- Aequor (Aliquippa, PA)
- …remote schedule and be available at the committed times. Qualities/characteristics the hiring manager is looking for in candidates to work best with their team: ... go-getter, detailed oriented, customer service oriented Things the hiring manager is looking for when reviewing resumes that stand...Degree OR Bachelor's Degree and 2 years of Life Science or Business experience preferably in the biotechnology or… more
- Merck & Co. (Durham, NC)
- …engineering design standards, guidelines and business plan; receives guidance from manager when necessary.Provides & Implements technical guidance to given tasks, ... systems regarding functionally of equipment and relied on as SME during regulatory discussions for HVAC/R. PROBLEM SOLVING: Identifies and resolves technical and… 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 ... technical and career, of direct reports, and mentors or acts as functional manager of skip-level or ex-US staff. This position requires strong knowledge about RBQM,… more
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