- Merck & Co. (Rahway, NJ)
- …agencies and/or subsidiaries for all applications and submissions and be responsible for regulatory review and final approval for all submissions and associated ... Job DescriptionThe Director / Principal Scientist, Regulatory Affairs Liaison...approval by agencies for conduct of clinical trials.Participate in regulatory due diligence activities for licensing candidate review… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to address regulatory questions from Global Health Authorizes (HAs) during review of device submissionsIn collaboration with CDx lead work with Dx partners to ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CMC regulatory experienceSuccessful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and EMA Competencies: Advanced ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Associate Director , Utilities Electrical Engineer is a member of the Plant Engineering team providing technical support to the Durham Site.- The ... Global Vaccine Technology (GVTE), Automation, and Quality approvers.-Perform a thorough review of design & engineering records and related Good Manufacturing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …practices.Collaborate effectively with IT to align system development with business and regulatory expectations. Review systems for affiliate companies to assess ... other research areas centered around rare diseases and immune disorders. SummaryThe Sr. Director , Data Quality and Integrity (Global R&D & PV QA) ensures high… more
- Eisai, Inc (Exton, PA)
- …Development groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of ... profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible...R&D and CMO personnel. Provide technical support and document review for phase III and PV at CMOs at… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... pharmacodynamic endpoints/platforms, and early phase vaccine trials.Reporting to the Executive Director and Head of TMS (in EDS/BARDS), the incumbent will manage… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAbout the Role:-As a Technical Lead, you will report into Director , Chemical Technical Operations, External Manufacturing API Technology, and play a ... diligence assessments and provide expert consultation on chemical manufacturing matters. Review process change requests and deviation reports while ensuring … more
- Eisai, Inc (Raleigh, NC)
- …If this is your profile, we want to hear from you. The Director Western Supply Chain Management (SCM) Unit is accountable and/or responsible for providing ... production plans and/or transition plans to meet the demand forecast. The Director , Western SCM Unit will lead a cross-functional team driving excellence in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ultimately negotiated with PBM/payer customers. Relationships Reports to the Executive Director , Strategic Pricing & Contracting. Responsible for leading a team of ... Presents at Pricing Committee and Pre-PC for aligned accounts and leads review of business case and financial impact scenarios. Ensures appropriate stakeholder… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the vision and ... position requires strong knowledge about RBQM, and related processes, policies, regulatory requirements and ICH guidance. This position requires excellent project… more
- Merck & Co. (Durham, NC)
- …Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director ).-This role serves as a Virtual Plant Manager - responsible for ... all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a strong business… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionOur company seeks to add an Associate Director . Veterinarian Services at our Millsboro, Delaware location. This position will have overall ... documentation, and other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory inspections… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as well as other research areas centered around rare diseases and immune disorders.SummaryThe Director , Clinical Safety, will be a product safety lead or part of a ... surveillance, signal detection and management, important safety topics, and regulatory submissions. This individual will ensure proactive safety monitoring and… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionThe Director of Medical Writing will be responsible for developing and implementing ... writing strategies and operational plans.Responsibilities Leads and manages the writing, review , and finalization of clinical development documents such as protocol… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …this position possesses advanced knowledge of clinical operations and relevant regulatory requirements. This position has advanced experience working on Phase I-IV ... therapeutic areas and is capable of leading DM activities to support regulatory submissions and inspections. Finally, this position has advanced skills in continuous… 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 ... that audit targets for MA audits are in place. Review risk assessment documents stemming from audit outcome to...preparedness for the respective MA inspections in alignment with regulatory and company strategy. Act as management representative for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Executive Director , Head of Center of Excellence (CoE), Global Medical Safety will ... product safety team in critical areas such as individual case medical review , risk management, aggregate safety reports, and translational medical safety. This role… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Liaisons to ensure successful implementation of CDx and data collection Supports Regulatory affairs in providing content and providing review of documents ... clinical trial sample testing activities and data capture to support CDx regulatory submission or associated drug regulatory submissions. Contributes to CDx… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …decision. By guiding other internal programmer or by self, perform programmatic review of Study Date Tabulation Model (SDTM) and analysis (including Analysis Data ... effective vendor programming implementation, and expedite the preparation of regulatory submissions. Responsibilities include: make strategic programming decision and… more
