- Merck & Co. (North Wales, PA)
- …Material(s):Required Skills:Business Development, Business Development, Business Management, Clinical Documentation , Clinical Investigations, ... Clinical Judgment, Clinical Reporting, Clinical Research, Clinical Trial Documentation , Clinical Trial Planning, Consultative Approach,… more
- Merck & Co. (Upper Gwynedd, PA)
- …License:Hazardous Material(s):Required Skills:Animal Vaccination, Animal Vaccination, Biological Field Work, Clinical Development, Clinical Documentation , ... --The Senior Director will report to an Associate Vice President in the Oncology Clinical Research Group. Under the guidance of a supervisor, the Senior Director has… more
- Insmed Incorporated (San Diego, CA)
- …and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical Quality Assurance ... compliance related to GCPs, acts as quality lead on the gene therapy clinical development team, and collaborates on other related activities performed by Clinical… more
- Merck & Co. (North Wales, PA)
- …of programming deliverablesProduce SAS transport files and associated documentation for regulatory submissionsEducation and Minimum Requirement:BA/BS in Computer ... or related field plus 5-9 years SAS programming experience in a clinical trial environmentMS in Computer Science, Statistics, Applied Mathematics, Life Sciences,… more
- Insmed Incorporated (San Diego, CA)
- …to cross-functional teams and senior leadership, as neededCollaborate with Clinical Development, Clinical Operations, CMC, QA/QC, Nonclinical, Program ... risk mitigation plans for key partnersProvide regulatory review of documentation prepared by other technical functions supporting product development activities… more
- Merck & Co. (Boston, MA)
- …the path to market. The goal of this product is to inform-pre- clinical development, dose selection-and target discovery utilizing modeling, pathway analysis and ... Collaborate with external vendors supporting target identification, validation, and pre- clinical /non- clinical development to evaluate opportunities, influence their… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …activities- Oversee the quality and timeline of vendor work- Collaborate with study clinical or medical lead and biostats to ensure availability of necessary data- ... of authorship agreements, financial disclosures and author approvals- Ensure documentation of compliance with authorship and publication guidelines as stipulated… more
- Merck & Co. (Rahway, NJ)
- …company's biologics pipeline. We work closely with colleagues in Discovery, Pre- clinical and Early Development to rapidly develop manufacturing processes for diverse ... biotherapeutics and efficiently manufacture material to supply clinical trials. We are also responsible for commercial process development and the development and… more
- Insmed Incorporated (Miami, FL)
- …assigned budget parametersIs accountable for the accurate and timely documentation of all activitiesIdentify Medical Experts, consultants, investigators, and ... a local medical and scientific resource to Insmed for product planning, clinical insights, and intelligence. Bring together, synthesize and deliver HCP derived… more
- Merck & Co. (Upper Gwynedd, PA)
- …skills, and a background in pharma/biotech. Previous experience with implementing and managing clinical and regulatory data standards is a big plus.- If you believe ... are not limited to:Identifying, evaluating & implementing new scientific, clinical and regulatory reference data sourcesEnsuring timely authoring, publication and… more
