- Merck & Co. (Rahway, NJ)
- …and change management.Familiarity with United States and European Union GMP and Safety compliance regulations.Ability to convert new drug product attributes and ... (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …supporting early clinical safety for our Rare Disease/Specialty Medicine portfolio. SummaryThe Director , Clinical Safety , will be a product safety lead ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...safety team, and be responsible for overall product safety strategy or specific areas of safety … more
- Merck & Co. (Rahway, NJ)
- …developing, and scaling-up the formulation, device, and manufacturing process.- Driving drug product design from the benchtop to current Good Manufacturing Practice ... manufacturing facilities, our scientists use cutting edge science to transform drug delivery and manufacturing technology to positively impact patients.The … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJoin Our Team as a Biologics Drug Substance & Cell Banking Leader!Are you ready to take your career to the next level? We are seeking a dynamic and ... visionary-Biologics Drug Substance & Cell Banking Leader-to spearhead our cutting-edge cell banking and biologics commercialization within the expansive Biologics… more
- Merck & Co. (Rahway, NJ)
- …drugsAnalyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical ... Job DescriptionThe Senior Director (Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or… more
- Genmab (NJ)
- …have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading the development and maintenance ... will be within Global Regulatory Affairs (GRA) and will report to the Sr. Director , Labeling, Policy and Intelligence. The position may be based in our Princeton,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …experience in PV; required10 or more years of experience within Drug Safety /Pharmacovigilance experience, including both investigational and marketed products; ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Tris Pharma (Monmouth Junction, NJ)
- …(FDA), Drug Enforcement Administration (DEA), and Occupational Health and Safety Administration (OSHA) regulations, as well as all applicable company compliance ... in our Monmouth Junction, NJ facility for an experienced, hands-on SR. Director / Director , Procurement. Title and salary commensurate with experience. The … more
- Genmab (NJ)
- …the CSRAttend trial and investigator meetings if/as neededCollaboration with Genmab Global Drug Safety :Participate in definition, review, and approval of data ... would love to have you join us!The RoleThe Associate Director acts as a statistical expert supporting the clinical...and technical progress within the field of biostatistics in drug development and advise of new methodologies that may… more
- Merck & Co. (Durham, NC)
- …is seeking a dynamic and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate ... Director ).-This role serves as a Virtual Plant Manager -...test complex injection molded Device Components, Device Constituents, and Medical Devices used to deliver Pharmaceutical, Biologic, and Vaccine… more
- Eisai, Inc (Exton, PA)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... If this is your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and building a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to determine risk factors with and for other technical departments (eg, Clinical, Medical , Safety , Data Management, Statistics). This position requires skills in ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets… more
- Merck & Co. (Rahway, NJ)
- …drugsAnalyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical ... Job DescriptionThe Director (Principal Scientist) has primary responsibility for the...of generating early clinical development plan and Investigational New Drug applicationsDeveloping of clinical development strategies for investigational or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …external stakeholders to ensure consistent, accurate communication of medical and drug information. Relationships Reports to a Director level employee in ... in NNI. Key relationships include Medical & Scientific Affairs, Field Medical Affairs, Product Safety , Customer Care, Sales, and Marketing. Essential… more
- Merck & Co. (Rahway, NJ)
- …drugs;Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical ... Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new… more
- Merck & Co. (North Wales, PA)
- …drugs.Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical ... Job DescriptionThe Director (Principal Scientist) has primary responsibility for the...of generating early clinical development plan and Investigational New Drug applications.Developing of clinical development strategies for investigational or… more
- Merck & Co. (Rahway, NJ)
- …areas- Ability to manage complex operations and projects under accelerated timelines- Scientific, medical and/or safety writing and reporting (at least one is ... improve the lives of patients worldwide. Through clinical trials, we ensure the safety and efficacy of our pipeline and existing products to produce safe, effective,… more
- Eisai, Inc (Phoenix, AZ)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... oral markets with approved indications, helping targeted customers, such as Medical Oncologists, Hematologists, Endocrinologists, and nurses, etc. learn about the… more
- University of Colorado (Aurora, CO)
- ** Medical Director for the Heart Institute Quality and Patient Safety -Associate Professor** **Description** **University of Colorado Anschutz Medical ... Campus** **Department: Pediatrics - Cardiology** **Job Title:** ** Medical Director for the Heart Institute Quality and Patient Safety ** **Position #:… more
