- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/ Associate Director , has primary responsibility for ... authors study protocols, develops measurement questionnaires, case report forms, data analysis plans, final study reports, scientific presentations, and… more
- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionGRACS CMC - Associate Principal Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr Principal ... global regulations and guidances, and is-responsible for the preparation and submission of CMC dossiers for all assigned development products. -Primary… more
- Genmab (NJ)
- …love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading the development and ... maintenance of global labeling documents (eg, Core Data Sheet, USPI, EU SmPC and related patient information)...Regulatory Affairs (GRA) and will report to the Sr. Director , Labeling, Policy and Intelligence. The position may be… more
- Genmab (NJ)
- …feel like a fit? Then we would love to have you join us!The RoleThe Associate Director acts as a statistical expert supporting the clinical development of ... as trial responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to support BDM analysis and reporting, such as R shiny apps for data surveillance, visualization, modeling and simulations, and safety signal detection. Lead the ... (ie, ILD). Collaborate with Clinical Development and Clinical Sciences for effective data surveillance Qualifications: Successful candidates will be able to meet the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …evaluation study integration of an assay into clinical testing (before testing) and once data is ready for CDx submission (after testing)Serve as the Point of ... critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for each country/region, both before and after CDx testing, for… more
- Repligen (Waltham, MA)
- OverviewThe Director of SEC Reporting and Accounting is responsible for overseeing the company's external financial reporting and ensuring compliance with SEC ... requires expertise in SEC reporting, US GAAP, and financial controls. The Director will work closely with senior leadership, auditors, and cross-functional teams to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with AROs/CROs. Drafts development plans, protocol profiles, and sections of submission documents under guidance of higher level. Reviews and oversee completion ... Teams.Responsibilities: Study Strategy: Provides the strategic direction to Biostatistics Data Management & Data Ops for EDC, edit checks, data quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is accountable ... QA RDPVQA, and oversees multiple levels of direct reports (Directors, Associate Directors, Managers, contractors as applicable) across the Global Quality teams… more
- Merck & Co. (Rahway, NJ)
- …regulatory submissions.-Under the general scientific and administrative direction of the Director in Biologics Cell Culture Sciences group and working in conjunction ... generation process development and characterization, process validation, and regulatory submission authoringIn this role, the successful candidate will be… more
- Immunome, Inc. (Bothell, WA)
- …undisclosed targets with expression in multiple solid tumors. Position Overview The Associate Director , DMPK will develop and implement comprehensive plans to ... data for all assets from research through regulatory submission for drug approval. Executes on plans to provide...communicate complex information succinctly. WA State Salary Range - Associate Director , DMPK: $185,683 - $214,200 WA… more
- Kura Oncology (Boston, MA)
- …Veeva. Ability to travel up to approximately 10% of the time. The base range for an Associate Director is $175,183 - $204,532 per year and for a Director it ... points of view. Solid understanding of drug development, clinical research, data analysis, Common Technical Document (CTD), ICH guidelines, GxP, regulatory… more
- Arrowhead Pharmaceuticals (Pasadena, CA)
- …bring new therapies to patients in need. The Position We are seeking an Associate Director , Medical Publications to drive the development and execution of ... supporting both pre-launch and post-launch initiatives. Reporting to the Senior Director of Publications, this role will lead the Medical Publications Strategic… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to support BDM analysis and reporting, such as R shiny apps for data surveillance, visualization, modeling and simulations, and safety signal detection. Lead the ... (ie, ILD). Collaborate with Clinical Development and Clinical Sciences for effective data surveillance Qualifications: Successful candidates will be able to meet the… more
- Flagship Pioneering, Inc. (Cambridge, MA)
- …Company's annual list of the World's Most Innovative Companies. The Senior Manager/ Associate Director , Strategic Business Operations and Analytics will be on ... knowledge, financial knowhow and business acumen to build models, interpret data , draw conclusions, and make recommendations that deliver results, drive… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. The Opportunity This Associate Director Regulatory Affairs - APAC will work on-site at ... Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs, APAC (Asia Pacific)...Lead cross functional groups in the development of relevant data to complete a regulatory submission . Develop… more
- BioSpace (South San Francisco, CA)
- …* Must be able to come onsite 3 days per week Purpose: The Associate Director , Statistical Programming leads the whole stat programming team within CDOR ... for OED all clinical projects conducted by CROs. The associate Director leads the recruitment and training...related to CRF designs and database designs. Derivation Programming, Submission Data Sets and Programs: Demonstrated proficiency… more
- Alkermes (Waltham, MA)
- …and clinical pharmacology; experience having direct interaction with FDA, including submission of IND, NDA and other regulatory documents is required. Writing: ... Experience in non-compartment and model-based PK and PK/PD analyses and inclusion of data in the preparation of manuscripts, study reports and sections of regulatory… more
- ICL (New York, NY)
- …5. May be directed to provide oversight in submission of statistical data . Assist the Program Director in Assuring Fiscal Control and Accountability: 1. ... JOB SUMMARY The Associate Program Director is responsible for...discharge planning is provided. 7. Supervises the development of data , records and/or reports as requested and required by… more
- HUMAN TECHNOLOGIES CORPORATION (Rochester, NY)
- …Creating Employment for People with Disabilities is Our Mission We are hiring an Associate Director for Environmental Services in the Rochester, NY area. Human ... we can make a significant and meaningful impact. The Associate Director will support our mission to...and off the job. 6. Responsible for providing operational data and support for Contract Renewal and/or Modification processes,… more
