TMF and Inspection Readiness Lead

6 days ago


Waltham, Massachusetts, United States Dyne Therapeutics Full time

About Dyne Therapeutics

Dyne Therapeutics is a clinical-stage biotechnology company focused on developing innovative therapeutics for genetically driven diseases.

Job Summary

The Senior Manager, TMF and Inspection Readiness will be responsible for managing technical documents, ensuring quality, and leading inspection readiness activities.

This role requires a scientific or health-related degree with at least 7 years of clinical operations and technical document management experience.

Key Responsibilities

  • Manage technical documents, ensuring accuracy and completeness
  • Lead inspection readiness activities, ensuring compliance with regulatory requirements
  • Collaborate with cross-functional teams to ensure seamless document management
  • Develop and implement processes to improve document quality and efficiency
  • Provide training and support to team members on document management and inspection readiness

Requirements

  • Scientific or health-related degree
  • At least 7 years of clinical operations and technical document management experience
  • Strong communication and leadership skills
  • Proficiency in Microsoft Excel, Word, and PowerPoint

Dyne Therapeutics is an equal opportunity employer.



  • Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Position OverviewDyne Therapeutics is a pioneering organization in the realm of muscle disease therapeutics, dedicated to the development of groundbreaking treatments for genetically driven conditions.Role ResponsibilitiesThe Senior Manager, TMF and Inspection Readiness will play a crucial role in overseeing the management of Trial Master File (TMF)...


  • Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Position OverviewDyne Therapeutics is a pioneering organization in the field of muscle disease, dedicated to developing cutting-edge therapies for genetically driven conditions.Role ResponsibilitiesThe Senior Manager, TMF and Inspection Readiness will play a crucial role in overseeing TMF documentation, ensuring compliance with quality standards, and...


  • Waltham, Massachusetts, United States Dyne Therapeutics Full time

    About Dyne TherapeuticsDyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative therapeutics for genetically driven diseases.Job SummaryThe Senior Manager, TMF and Inspection Readiness will be responsible for managing TMF files, ensuring quality, and leading inspection readiness activities.Key ResponsibilitiesManage and...


  • Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Position OverviewDyne Therapeutics is a pioneering organization in the realm of muscle disease, dedicated to the development of groundbreaking therapies for genetically influenced conditions.Role ResponsibilitiesThe Senior Manager, TMF and Inspection Readiness will take charge of overseeing TMF documentation, ensuring adherence to quality standards, and...


  • Waltham, Massachusetts, United States Visterra Full time

    Job OverviewPosition Title: Clinical Trial ManagerSalary: CompetitivePosition Summary:Visterra is in search of a Clinical Trial Manager (CTM) who will play a pivotal role within our Clinical Operations division. The CTM is instrumental in overseeing the execution and administration of clinical trials, reporting directly to the Associate Director of Clinical...


  • Waltham, Massachusetts, United States Visterra Full time

    Job OverviewPosition Summary:The Senior Clinical Trial Manager plays a pivotal role within the clinical operations division, facilitating the execution and oversight of clinical trials. Reporting directly to the Associate Director of Clinical Operations, this position is essential for ensuring the success of clinical studies.Key Responsibilities:Directing...


  • Waltham, Massachusetts, United States Hancock Claims Consultants Technicians Full time

    Job OverviewElevate your career and embrace the American Dream by partnering with a leading provider in roof and property inspection services. As an independent contractor, you will work closely with insurance companies and adjusters in your region.We are in search of skilled inspectors to become part of our proactive field team. Hancock offers a unique...


  • Waltham, Massachusetts, United States Hancock Claims Consultants Technicians Full time

    Position OverviewElevate your career and embrace the American Dream by becoming a vital part of a leading provider in roof and property inspection services. This role involves working collaboratively with insurance companies and adjusters in your locality. Please note that this is an independent contractor role.We are on the lookout for skilled inspectors to...


  • Waltham, Massachusetts, United States Hancock Claims Consultants Technicians Full time

    Position OverviewCLIMB to New Heights...And embrace the American Dream.Become part of a significant initiative by contracting with a leading provider of roof and property inspection services collaborating with insurance companies and adjusters in your vicinity. This role is structured as an independent contractor position.We are in search of skilled...


  • Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time

    Job OverviewCompany Overview:Deciphera Pharmaceuticals is a pioneering biopharmaceutical organization dedicated to the discovery, development, and commercialization of transformative therapies aimed at enhancing the lives of individuals battling cancer. Our innovative switch-control kinase inhibitor platform, combined with our profound knowledge in kinase...


  • Waltham, Massachusetts, United States Visterra Full time

    Job OverviewPosition Title: Senior Clinical Trial ManagerSalary: CompetitiveSummary:The Senior Clinical Trial Manager plays a pivotal role within the clinical operations division, overseeing the execution and administration of clinical trials. Reporting directly to the Associate Director of Clinical Operations, the ideal candidate will possess a B.S. degree...


  • Waltham, Massachusetts, United States Elevatebio Full time

    ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.The Role:ElevateBio...


  • Waltham, Massachusetts, United States Visterra, Inc. Full time

    SummaryThe Senior Clinical Trial Manager is a key member of the clinical operations team and supports the execution and management of clinical trial(s). The Senior Clinical Trial Manager reports to the Associate Director, Clinical Operations. The ideal candidate should have B.S. degree in science or healthcare and a minimum of seven years of clinical...


  • Waltham, Massachusetts, United States Upstream Bio Full time

    Job SummaryWe are seeking a seasoned professional to lead our clinical site management and monitoring efforts. As a key member of our clinical operations team, you will be responsible for establishing and overseeing site management and monitoring activities across global clinical trials.Key ResponsibilitiesSite Management and Monitoring Oversight: Plan,...


  • Waltham, Massachusetts, United States CSL Behring Full time

    About the RoleCSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. Our company is committed to delivering medicines that improve their lives.We are seeking an experienced Associate Director Clinical Portfolio Execution to join our...


  • Waltham, Massachusetts, United States Upstream Bio Full time

    Job DescriptionJob Title: Director, Clinical Site ManagementCompany: Upstream BioJob Summary:We are seeking a seasoned professional to lead our clinical site management efforts. As a key member of our clinical operations team, you will be responsible for establishing and overseeing site management and monitoring activities across global clinical trials.Key...


  • Waltham, Massachusetts, United States National Grid Full time

    About National GridWe are a leading energy company that delivers safe and secure energy to homes, communities, and businesses. Our mission is to connect people to the energy they need for the lives they live.We are committed to shaping the sustainable future of our industry by anticipating the needs of our customers, reducing the cost of energy delivery, and...


  • Waltham, Massachusetts, United States National Grid Full time

    Job SummaryWe are seeking a highly skilled Lead Engineer to join our Gas Engineering Team at National Grid. As a key member of our team, you will be responsible for providing engineering decision-making abilities for the development and maintenance of the Gas Distribution network.Key ResponsibilitiesInterface with major industrial and commercial customers,...


  • Waltham, Massachusetts, United States Alkermes, Inc. Full time

    Job Summary:The Director of Quality Assurance and Pharmacovigilance is a key leadership position responsible for overseeing the Clinical Quality Assurance Department at Alkermes, Inc. This role plays a critical part in ensuring the quality and integrity of post-marketing pharmacovigilance practices and commercial operations that contribute to the company's...


  • Waltham, Massachusetts, United States Upstream Bio Full time

    Job SummaryWe are seeking a seasoned professional to lead our clinical site management and monitoring efforts. As a key member of our clinical operations team, you will be responsible for establishing and overseeing site management and monitoring activities across global clinical trials.Key ResponsibilitiesSite Management and Monitoring Oversight: Plan,...