Oversee operational preparation and execution of regulatory submissions, ensuring technical compliance and timely delivery.
Manage routine submissions like INDs, CTAs, and health authority responses, while supporting complex filings and maintaining submission plans.
Compile, publish, and validate eCTD packages, coordinate submission delivery, and maintain accurate records in Veeva RIM.
A partner company of Jobgether, a pharmaceutical and biotechnology organization focused on developing innovative oncology therapies. The company values regulatory precision and operational efficiency across global programs, with a remote-first culture.
Prepare and publish regulatory submissions including eCTD packages for IND, CTA, and Health Authority responses.
Maintain submission plans, follow up on document readiness, and perform document- and submission-level technical QC.
Support Veeva RIM records, promotional submissions (Form FDA 2253), and submission-related projects.
Summit Therapeutics is a biopharmaceutical oncology company focused on improving quality of life and resolving serious unmet medical needs. Its global team is driven by core values of integrity, collaboration, and purposeful urgency, with multiple Phase 3 clinical studies in oncology.
Serve as the primary resource for lease, contract, and transaction-related legal documentation, configuring and testing document tags in lease/loan systems.
Create, review, and maintain documentation per legal and compliance requirements, performing quality checks to ensure audit readiness.
Support process improvements and project coordination, creating job aids, templates, and standard work instructions.
GE HealthCare is a leading global medical technology and digital solutions innovator focused on improving lives. The company fosters a culture of care, collaboration, and support, offering career opportunities and a collaborative environment.
Lead or co-lead medical writing and document quality projects, managing timelines.
Collaborate with cross-functional study teams to develop content strategies.
Review and verify documents against source materials for accuracy and compliance.
This partner company works in pharmaceutical and biotech development, creating scientifically rigorous medical content for evidence-based healthcare decisions. It emphasizes collaboration, professional development, and an inclusive culture.
Manage daily team operations, resources, and performance metrics for RFP reviews and testing determinations.
Provide subject matter expertise, escalation support, and training to team members and internal and external partners.
Collaborate with operational and scientific teams to improve processes, maintain client relationships, and ensure accurate proposal responses.
ACM Global Laboratories provides specialized clinical laboratory and scientific affairs services supporting clinical trials. The company is dedicated to being patient-driven, with global teams focused on high-quality work and operational excellence.
Design and execute stability studies across the gummy portfolio, tracking timepoints and sharing data with stakeholders.
Validate analytical methods, identify detection limits, and negotiate with external testing labs.
Own the complete documentation suite for every SKU, ensuring audit-ready specs and paper trails.
This high-growth product organization develops a diverse gummy supplement portfolio. They operate as a fully remote, high-trust team with biannual in-person off-sites.
Provides administrative and project support for quality assurance and program activities.
Coordinates project logistics, documentation, procurement, and compliance processes.
Maintains records, tracks deliverables, and supports audit-ready documentation across workstreams.
This organization is dedicated to international development and quality assurance programs. It fosters a collaborative, mission-driven culture with a focus on inclusion and professional growth.
Execute functional and regression tests on completed campaign builds to verify timing, routing, and message behavior end to end.
Own a queue of QC cases from intake to documented close, prioritizing by urgency and launch dates.
Partner with Build and Product Engineering to document and communicate defects clearly.
Drips engages people in two-way, compliance-governed SMS conversations through automated text and phone campaigns, helping organizations connect with customers at scale. Drips is a remote-first team that values accuracy, thoroughness, and clear documentation.
Support end-to-end eQMS implementations for life sciences organizations, coordinating timelines, deliverables, and risks.
Participate in system configuration, data migration, validation documentation, and UAT to ensure regulatory and data integrity compliance.
Collaborate with Quality, IT, Validation, vendors, and client teams across all implementation phases, including go-live and post-implementation support.
The hiring partner company supports end-to-end Quality Management System implementations for life sciences clients. They offer a remote contract-to-hire opportunity with potential for long-term growth.
Lead medical writing for one or more clinical programs and drive content strategy for clinical and regulatory documents.
Author and manage high-quality clinical study protocols, investigator's brochures, clinical study reports, and global regulatory submissions.
Collaborate cross-functionally, mentor direct reports, and incorporate process improvements to support R&D needs.
Deciphera is a biopharmaceutical company dedicated to developing innovative medicines for people living with cancer. They value diversity and offer a competitive compensation and benefits package, fostering a culture of collaboration and professional growth.
Review and verify credentialing documents, licenses, and background reports against client-specific standards.
Collaborate with onboarding teams to ensure files are accurate, complete, and ready for approval.
Monitor document trends and support continuous improvement to reduce errors and enhance efficiency.
This company provides healthcare staffing services with a focus on clinician credentialing and onboarding. While the company size is not specified, it fosters a collaborative, service-oriented culture emphasizing accuracy and compliance.
Create and maintain technical documentation for the Solid Rocket Motor program, including operations, maintenance, and repair instructions.
Collaborate with engineering teams to gather and verify technical data and ensure materials follow established standards.
Manage document approval, distribution, modification, and retention in compliance with policies and regulations.
General Dynamics Ordnance and Tactical Systems designs and produces munitions, energetics, weapons, and missile subsystems for the U.S. military and allies. The company fosters a culture of integrity, innovation, customer satisfaction, and collaboration, offering a robust total rewards package.
Own firm-wide document quality standards, templates, formatting, and final-production QA.
Serve as the advanced Microsoft Word expert and manage proposal production, including PDF assembly and submission-package QA.
Act as Confluence/SharePoint librarian and drive AI-enabled document workflows.
Sabot Consulting is a management consulting company focused on providing technical and management consulting to IT executives and managers. The company emphasizes expert staff with the knowledge, experience, and professionalism to engage clients at all levels.
Review and approve validation of software and AI products to ensure full compliance with regulatory requirements and company policies.
Prepare for and support external regulatory audits; lead internal or vendor audits related to maintaining GxP and regulatory compliance.
Develop and maintain digital/software components of quality management systems, including AI quality management systems.
Care Access brings world-class research and health services directly to communities that often face barriers to care. With hundreds of research locations, mobile clinics, and clinicians across the globe, they are reimagining how clinical research and health services reach the world.
Lead preparation of state authorization applications, renewals, annual reports, and related filings.
Research and monitor state regulatory requirements affecting academic programs and distance education.
Develop and maintain compliance calendars, tracking systems, and documentation repositories.
Saybrook University is a non-profit, regionally accredited university known for humanistic studies and rigorous research. It offers advanced degrees in psychology, counseling, and organizational systems, and fosters a diverse and inclusive community.
Lead regulatory operations across the portfolio and build/manage the Regulatory Information Management System.
Drive submission planning and execution for regulatory submissions, including DSURs, IBs, and marketing applications.
Establish efficient processes for regulatory records, document management, publishing, and health authority correspondence.
Erasca is a clinical-stage precision oncology company focused on discovering, developing, and commercializing medicines for patients with cancer. The company fosters a casual, collaborative, and entrepreneurial culture in a small or mid-sized biotech environment.