- Formation Bio (New York, NY)
- …product release, stability programs, change management, and vendor oversight. The Sr. Director ensures compliance with cGMP standards, oversees QA activities at ... bring new treatments to patients faster and more efficiently.About the PositionThe Sr. Director , GMP Quality Assurance will lead the GMP QA strategy and execution… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. JOB SUMMARYThe Associate Director , GMP QA Process Excellence is accountable to collect information, analyze ... the organization.This role will focus on driving operational efficiency, ensuring compliance with industry standards, and fostering a culture of continuous… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …studies and applicable changes that may require DS support. Ensure respective compliance with applicable DSI and or DS relevant procedures, standards and ... along with first-hand knowledge of drug manufacturing, packaging, QA, compliance and audit.Experience with biological manufacturing and technical transfer required… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management ... Data Validation and Reporting resources, CROs, and vendors to ensure compliance with the programming standards and practices, SOPs, external/internal data standards,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Strategy:Align with the Head of Clinical Development Operations or Senior Director , Clinical Operations on plans for successful implementation of studies. ... so both can be managed appropriately.Provide oversight of the CRO to ensure compliance with Daiichi Sankyo's quality measures. Leads the creation of the Risk… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by managing labeling development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to Core Data Sheets for ... as well as for the review of country labeling deviations.Ensure Compliance with Labeling Regulations and Guidance: Researches applicable Health Authority labeling… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration ... with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL)Study Planning and Execution: Provides input on major milestones of trial, clinical trial plan and contingency planning; Analyzes and updates management on potential risks to study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to other study sites.Introduce and implement methods to detect fraud or site non- compliance such as: different approaches to data review in conjunction with Data ... Management and Clinical Science, audit trail review for non-logical timing of entry and/or source data collection, use of statistical control charts to identify trends, or use of statistical methods to identify site differentials.Participate in CRO / vendor… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and data analytics to enhance decision-making and streamline operations. Ensure compliance with regulatory requirements and industry standards in all improvement ... initiatives.Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university) Bachelor's Degree BS degree with relevant… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technical and service management principles for HRIT support, data security and compliance as well as functional and solution knowledge pertaining to Performance, ... Compensation, Variable Pay and proficiency in relevant software and tools are essential.Business Expertise: Good understanding of industry and comprehensive knowledge of HR functional areas and processes and understanding how they interact and contribute to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …operations and activities for all US (multi-state) and Canada regions, ensuring compliance with company policies and statutory regulations. This position will be ... and liaise with Human Resources, Finance & Accounting, Tax, Compliance and Legal team members to ensure compliance... Compliance and Legal team members to ensure compliance with all relevant regulatory, accounting, tax and internal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …business teams introducing improved systems experience, cost savings, and compliance . - Stakeholder CollaborationAdvocate for the Global HRIS and collaborate ... with respective regional leads to align and incorporate system maintenance controls.Collaborate across each functional area of HR working with COEs, HR and Business leaders to understand their specific requirements building strong relationships based on trust,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director , Global Cardiometabolic Communications will be part of the Global Pharma communications team and will collaborate closely with ... support of the US- and global cardiometabolic business.The Associate Director will report to the Director , Global...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Rahway, NJ)
- Job Description Overview: The Director , Global Media Relations, is responsible for developing and executing a global media strategy that showcases our company's ... development, product approvals, thought leadership, policy, and overall performance. The director will build and maintain strong working relationships with pharma,… more
- Merck & Co. (Rahway, NJ)
- …and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical Development organization and ... communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Director - Pharmacometrics, Quantitative Pharmacology and PharmacometricsThe Quantitative Pharmacology and Pharmacometrics (QP2) department ... at our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate Director … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the guidance of a senior leader, a director has primary responsibility for developing value evidence strategies, and planning/managing real ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Merck & Co. (Rahway, NJ)
- …strategies and robust forecasts for in-flight and emerging discovery programs.The Director , Global Brand Lead is focused on developing a future-focused view ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Merck & Co. (Rahway, NJ)
- …decision-making at our company, this position offers an opportunity for the Director to drive pipeline impact and mentor/coach a talented group of ... pharmacometricians.The Director -Pharmacometrics will work with scientists within QP2 by proactively...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Rahway, NJ)
- …Analytical Enabling Capabilities Department has an exciting opportunity for a Director of Nuclear Magnetic Resonance (NMR).- The NMR Lead provides strategic ... partners across Discovery Chemistry, Process Development, and Pre-Clinical Development.The Director reports to the Executive Director , Structural Elucidation… more
