- Merck & Co. (North Wales, PA)
- …stakeholders and is a member of several cross-functional teams, including the Promotional Review Team (PRT), and the US and Global Medical Affairs Teams. ... based on scientific evidence and clinical context.Member of Promotional Review Team (PRT) responsible for ensuring the...Coordination and Alignment-Proactively engage with Global Scientific Content (GSC) team lead and team members,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …entire project. Act as statistical expert in the assigned projects. Guides the project team in using the most efficient or innovative study design by considering the ... project; Leads the planning and analysis of integrated efficacy and safety data; Review the relevant sections of the electronic common technical document … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the direction of the Senior Director, GMA Oncology ADC (Global Medical Affairs team lead for compound), is responsible for assisting with defining ... review of investigator-initiated studies (IIS) and may serve as deputy compound lead in Global IIS Review Committee meetings.Leads external medical education… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and amendment processes (CDDS, USPI, SmPC, CHMP) as a member the Label Working Team - Lead development of the TPP through interaction with all regional ... indication(s) and/or tumor type(s) under the direction of the Global Brand Lead . Responsible for actively contributing to the development of the global brand… more
- Aequor (New Brunswick, NJ)
- …for the stability program on assigned brand (s) and acts as Stability Product Lead . Participates on transfer team for new products to internal and external ... program in support of the change Perform change control impact assessments and document the stability assessment in change controls. Review and endorse change… more
- Merck & Co. (North Wales, PA)
- …success together with risk mitigation measures. Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of ... sections for commercial or new biologics products. The Principal Scientist will lead the development and the implementation of internal regulatory strategies and… more
- Aequor (Thousand Oaks, CA)
- …new and supplemental drug applications/biologics license applications Serve as functional area lead on product teams (eg, Global Regulatory Team , Evidence ... Lead departmental and cross-departmental initiatives, as appropriate Generate document timelinesPreferred Qualifications: Experience leading writing activities for new… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study problems. ResponsibilitiesProtocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, ... medium complexity studies including study design, protocol development, CRF review , SAP development, analysis files development, statistical analysis accuracy… more
- Merck & Co. (Rahway, NJ)
- …The Specialist - Manufacturing Automation position will report to the Director, Engineering, Automation Lead position and will be a member of the EF Team at ... the Rahway site are calibrated and qualified as required.- Also, this role will lead any future changes to the system such as system expansion projects from either… more
- Merck & Co. (Boston, MA)
- …include the clinical pharmacology support of the Common Technical Document (CTD) and label, including relevant compound/program life-cycle management.The successful ... TMed at governance for the Immunology portfolio (discovery therapeutic area review , early and late-stage clinical governance), and fully supportive of external-based… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study problems.Responsibilities- Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, ... for complex studies including study design, protocol development, CRF review , SAP development, analysis files development, statistical analysis accuracy validation,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …sets that meet functional / non-functional business requirements Excellent technical writing, document organization, technical document review and analytical ... About the Department At Novo Nordisk, our Finance and Operations team is the engine that elevates holistic commercialization of our products. The Finance and… more
- Merck & Co. (Rahway, NJ)
- …The Specialist - Manufacturing Automation position will report to the Director, Engineering, Automation Lead position and will be a member of the EF Team at ... engineer role at the Specialist level will serve as technical SME and capital team member supporting the Modality Agnostic Chemistry Scaleup (MACS) Center. This is a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …mentor, develop, retain, and manage direct and indirect reports and/or matrix teams. Directly lead a team of >30 FTEs and contractors across regions including ... and with company objectives. The Head of GRA Global Labeling leads a team of labeling strategists, labeling operations, and compliance specialists located across the… more
- Catalent (Harman, WV)
- …requirements. They are responsible for establishing and maintaining the site metrics, management review , and building a Patient First culture at the site. The Head ... methods and other Quality Control procedures is performed on manufactured products. Review and approve Site Annual Product Reviews.Ensure that required validation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and refine our strategies based on real-world results. We are building an intentional team culture that is made up of diverse skillsets, united by the shared belief ... across multiple therapeutic areas/brands to ensure scalability, cost savings and alignment Lead and/or participate in key TA/Brand governance teams as well as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document . Collaborates as team member with AROs/CROs. Drafts development ... data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before database lock and quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study problems. Responsibilities Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, ... for complex studies including study design, protocol development, CRF review , SAP development, analysis files development, statistical analysis accuracy validation,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …on-the-job training, career development, appraising performance, and motivating their team and peers to perform at their best.Job ResponsibilitiesOversees, manages, ... the successful day-to-day operations of the Automation Engineering department.Generate, review , approve and control departmental documentation (eg, SOPs and system… more
- Merck & Co. (Rahway, NJ)
- …Associate Specialist - Manufacturing Automation position will report to the Director, Engineering, Automation Lead position and will be a member of the EF Team ... Chemistry Scaleup (MACS) Center :- This role could serve as technical and capital team member supporting the MACS Center capital project. This is a new potent,… more
