- Insmed Incorporated (Westerville, OH)
- …mission to transform the lives of patients. They must possess a high clinical aptitude and experience in portfolio selling environment to engage key customers. Along ... field-based role and can be located in or around Westerville, Ohio.Responsibilities Develop, lead , and execute a sales plan with specific goals and targets to… more
- Merck & Co. (Rahway, NJ)
- …with company requirements and regulations are delivered and sustained. The Sr CCQM Lead supports large to medium size country/cluster clinical trial operations ... Quality Management (RCQM), and in collaboration with the Clinical Research Director(s), the Sr CCQM Lead ...performs QC activities (incl. QCVs) and conducts ad hoc site visits upon request.-On a regular basis and in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with DS standards. The Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO, 3rd Party Vendor Management and ... Has primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including critical… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Clinical Research Manager (CRM) - General Medicine (REMOTE) This role is primarily accountable for the end-to-end performance ... country in compliance with International Conference on Harmonization Good Clinical Practice(ICH/GCP) and country regulations,-Our Company's policies and procedures,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …LeadershipHas primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical study plan ... including critical path activities and interdependencies for assigned clinical stud(ies) utilizing Microsoft Project or equivalent. Lead the creation of the cross… more
- Merck & Co. (North Wales, PA)
- …of study start up by reducing the time from study initiation to first site ready.Remove obstacles and enable the Global Clinical Trial Organization to focus ... relies on accurate data collected from patients who are part of Clinical Trials. Trial Standards, Trial Design, Trial Data Collections, Trial Data Integrations,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … lead statistician on SAP update, as needed. Provides input to Clinical Operations on site issues. Contributes to development of CSR.External collaboration: ... immune disorders. Summary Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... compounds in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of clinical development,… more
- Insmed Incorporated (Bridgewater, NJ)
- …environment and provide oversight to external vendors.ResponsibilitiesResponsibilitiesFunction as a Clinical Pharmacology lead supporting assigned programs in ... in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director of Clinical Pharmacology role within Clinical Development organization will provide… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilitiesSummaryThis position will be the Clinical Science Group Lead in late phase development in the ... at the Senior Director level for each respective programThis Clinical Science (CS) Group Lead will be...with a focus on patient safety and data integrity, site scientific engagement, and HA responsesInteractions with the internal… more
- Catalent (PA)
- …pricing and ensure strong connectivity between the various Biologics sites.Assist and/or lead strategic continuous improvement projects at the site to develop ... Proposal Lead I Summary Catalent Biologics is a fast-growing...Program Management, Business Development, Commercial Operations, clients, and key site stakeholders on the timely generation of and pricing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …veterans and people with disabilitiesSummaryThe Associate Director, Global Oncology Clinical Development (GOCD) Functional Excellence supports the development and ... a library of educational slides to be used for Investigator Meetings, Site Initiation Visits (SIVs) and other educational needs across assetsPartners with IT… more
- Merck & Co. (Rahway, NJ)
- …enables gain of critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training ... project, and people management responsibility. - This SSO Facility Lead role within the SSO Pilot Plant leverages significant...members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of the processes, and… more
- Catalent (Manassas, VA)
- …sourcing and procuring materials, services, and capital for the site . The Site Procurement Manager will lead site procurement team and initiate ... Site Procurement ManagerPosition Summary Catalent is a global,...sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more… more
- Catalent (St. Petersburg, FL)
- Supplier Quality Regional Lead Position Summary: Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the ... of the Global Supplier Quality Management team, the Supplier Quality Regional Lead will be responsible for management and leading the Supplier auditors performing… more
- Merck & Co. (North Wales, PA)
- …Portfolio Marmeting Team, Integrated Account Management , Learning and Development, Clinical Review Teams, Legal and Compliance. In addition, this individual will ... with brand teams to understand priorities and synergies with commercial engagement.- Lead the development of resources through the promotional approval process;… more
- Merck & Co. (Rahway, NJ)
- …in the pharmaceutical industry (eg, Medical Affairs, Regulatory Affairs, Clinical , Pharmacovigilance).- - Required experience and skills: Project management skills ... working a Hybrid work consisting of three total days on- site per week, generally Tuesday, Wednesday and either Monday...or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and supports Supply Chain Management with technical issues post first CPV.Responsibilities- Lead and coordinate the Site -Launch activities and associated teams ... or gaps at the manufacturing sites.- Conduct scouting activities and recommend CDMOs for clinical and launch site selection from Tech Mgmt. (mAb, Drug Substance,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a QA Investigations Lead (2nd or 3rd shift) as part of the Quality team based in Raritan, ... NJ. Role Overview The QA Investigations Lead has the responsibilities for providing quality oversight over...production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Lead QC Microbiology Data Reviewer as part of the Quality team based in Raritan, ... New Jersey. Role Overview The Lead QC Microbiology Data Reviewer is an exempt level...the manufacturing facility utilized for cell therapy products for clinical trials and commercial operations in a controlled GMP… more
