- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with stability studies program performance in accordance with internal procedures and regulatory requirements in connection with contract testing laboratories to ... for support and manage Quality Management System (QMS) in accordance with regulatory requirements and to ensure the adherence to the Quality Manual. Responsible… more
- Merck & Co. (North Wales, PA)
- …drug /vaccine projects in Late Development Statistics.Interacts with Clinical, Regulatory , Statistical Programming, Data Management, and other company Research ... clinical trials, and in coordinating the statistical activities for clinical drug /vaccine projects. May interact with Contract Research Organization (CRO).This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth ... knowledge of regulatory authority's requirements.Typically has administrative responsibility for recruiting, retaining, developing, and managing employees. Guide… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted ... Health Authorities globally with some supervision. This position also guides contract research organization (CRO) programmers and statisticians in preparing analysis… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted ... to address various project needs. The position works closely with contract research organization (CRO) programmers and statisticians and collaborates with internal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …studies in which Medical Monitoring activities are conducted by the Contract Research Organization (CRO) Medical Monitor (MM):Provides oversight to the CRO ... the Target Product Profile (TPP)Development of clinical sections of trial-level regulatory documents (eg, response to HAs, briefing book, etc.) in conjunction… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …For studies in which Medical Monitoring activities are conducted by the Contract Research Organization (CRO) Medical Monitor (MM):- Provides oversight to the CRO ... the Target Product Profile (TPP)- Development of clinical sections of trial-level regulatory documents (eg, response to HAs, briefing book, etc.) in conjunction with… more
- Tris Pharma (Monmouth Junction, NJ)
- …with all Tris functions that contribute to the partnership, including R&D, Regulatory , CMC, Finance, Legal, and more. Understand their roles, their strategic ... to maintain high morale across teams and within organizations.Contribute to contract -related activities. Understand contract structure and obligations and… more
- Aequor (Providence, RI)
- Description 3 year contract 100% remote Shift/Schedule: 8:00 -4:30 pm (flex) -Monday - Friday **Candidates must have GMP and pharmaceutical experience** What you ... diverse functional areas including Supply Chain, Manufacturing, Quality Control, Regulatory , Quality Assurance, Quality Engineering, International Quality and Process… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …identify appropriate biomarker tests and technology solutions in DS wet labs, contract research organizations, and specialty labs for DS clinical trials; 2) provide ... training, clinical sample analysis, archiving of biomarker test results, and regulatory submission activities for Daiichi Sankyo clinical development. Contribute to… more
- Merck & Co. (North Wales, PA)
- …for price control as part of the Inflation Reduction Act, state Prescription Drug Affordability Boards, Medicare, Medicaid, and 340b, while planning for the loss of ... Integrated Account Management (IAM), Finance, the Washington DC Office, Commercial Contract Management (CCM), Business Development (BD), Global Market Access (GMAX),… more
- Insmed Incorporated (San Diego, CA)
- …including interpretation of results and reporting that stands up to regulatory inspection.Demonstrate expert knowledge of scale-up principles with respect to viral ... and procedures suitable for inclusion in pre-IND, IND, or equivalent regulatory submission;Must be familiar with BSL-II lab safety requirements;Participate in… more
- Spectraforce Technologies Inc (Atlanta, GA)
- Job Title: Product Management Contract Associate (100% REMOTE) Duration: 3+ Months Schedule Notes: Mon to Fri (8 - 5) Job Description Summary The Product Management ... Contract Associate has responsibilities for following processes related to...product support role (health systems, pharmacies, PBMs, insurance companies drug wholesalers, logistics, etc) No credentialing required, preference for… more
- Fidelity TalentSource LLC (Westlake, TX)
- …(ERISA, Internal Revenue Code, HIPPA, data privacy laws etc.)Identification of legal, regulatory and business risk, in concert with business partners, and proactive ... skills, which you will readily use to simplify sophisticated contract and business issues for straightforward, practical analysis and resolution.Executive-level… more
- T3i, Inc. (San Antonio, TX)
- …and acquisition of programs Develops strategies and oversees activities, including contract and task management, cost projection and tracking, budgeting, and ... regulatory compliance Develops and directs training and deployment of...exempt Travel: > 50 percent (CONUS and OCONUS) T3i Drug Free Workplace Statement: As a Federal Government Contractor,… more
- Fidelity TalentSource LLC (Boston, MA)
- …trading platforms and protocols, focusing on scalability, security, and regulatory compliance. Spearheading the design and development of innovative tokenization ... assets to realize the benefits of blockchain and smart contract and related technologies.Communications and Collaboration: Effectively communicating product plans,… more
- U of C NORC (Bethesda, MD)
- …regulatory complianceDemonstrated comprehensive knowledge of the Medicare prescription drug coverage and payment policy rules, regulations, and guidelines.Expert ... and policy projects, with an emphasis on those related to pharmaceutical drug pricing practices and costs.NORC recognizes that talented and skilled researchers live… more
- Hired by Matrix (Newark, DE)
- …calibrators. Products support testing for drugs of abuse and therapeutic drug monitoring. Following area procedures and manufacturing work instructions. Proper ... by following Good Documentation Practices. Complying with the quality system and regulatory agency requirements: FDA, DEA, ISO, OSHA, etc. Interaction with cross… more
- nrg (Princeton, NJ)
- …with corporate governance requirements (including charters and regulatory requirements)Provide corporate secretarial support, including preparing and ... management, due diligence, credit agreements and capital markets transactions, contract administration, and Sarbanes Oxley compliance.Perform additional functions and… more
- Community Hospital Corporation (Plano, TX)
- …chain processes, cost-savings initiatives, materials management efficiencies, and contract negotiations for owned, managed, and affiliate healthcare facilitiesThis ... strategic alliances to enhance the organization's competitive advantage.GPO & Contract Management:Spearhead GPO compliance and conversion initiatives to maximize… more
