Set up, maintain, reconcile, and archive electronic and paper Trial Master Files
Track study status, enrollment, regulatory documentation, laboratory samples, and site start-up status for assigned clinical projects
Actively order and maintain ancillary clinical study supplies required for the conduct of clinical studies
Vedanta Biosciences is a late-stage biopharmaceutical company developing medicines for the treatment of gastrointestinal diseases. The company’s pipeline has been built using the company’s industry-leading product engine for the development of therapies based on defined consortia of bacteria grown from pure clonal cell banks.
Provide operational oversight and support for multiple clinical research sites within the network.
Ensure adherence to GCP, FDA regulations, ICH guidelines, HIPAA, and sponsor protocols.
Build and maintain strong working relationships with Sponsors, CROs, and external partners.
Hawthorne Health is a leading community site network and home research visit solution provider, with 20+ sites and more than 2,000 research experienced healthcare professionals across the U.S. They leverage convenient, trusted healthcare locations, identified patient data, and intelligent technology to accelerate patient access, improve retention, and reduce study costs.
Own the end-to-end lifecycle of FDA premarket applications, with an immediate focus on authoring and steering 510(k) submissions to clearance.
Operationalize and maintain compliance across diverse and intersecting jurisdictions, including FDA (Device, Drug & Compounding) and CMS (CLIA/CAP).
Build and scale the "Technical Playbook" for medical product operations, ensuring the company stays ahead of shifting state, federal, and international regulations.
Hims & Hers is a health and wellness platform committed to better health by offering affordable and personalized care. As a public company traded on the NYSE, they are normalizing health & wellness challenges and innovating on their solutions to make better health outcomes easier to achieve.
Author, review, and manage clinical, regulatory, technical, and medical documents including protocols, study reports, and regulatory submissions.
Ensure strategic alignment and consistency of scientific messaging across documents while maintaining compliance with global regulatory requirements.
Drive the end-to-end writing process, manage timelines, and lead cross-functional reviews to deliver high-quality, on-time deliverables.
Kiniksa Pharmaceuticals is a commercial-stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, focusing on cardiovascular indications. The company fosters a highly collaborative, patient-first culture led by accomplished life sciences leaders, empowering talented individuals to make a real impact.
Supports all phases of clinical development and execution.
Ensures high quality data by being the study protocol expert and key site resource for questions.
Maintains and tracks clinical study data and supports investigator qualification selection.
SI-BONE is a medical device company focused on minimally invasive sacropelvic solutions. They aim to help patients with sacroiliac pelvic conditions and have provided over 90,000 procedures to date using their iFuse Implant System.
Serve as technical SME for CDISC SEND and SENDIG-AR (2019).
BryceTech is a trusted leader in complex technology domains, delivering data-driven solutions in aerospace, biosecurity, and defense. With a proven track record, they present a compelling opportunity for strategic partnerships in the GovCon space.
Preparation of Initial Investigational New Drug (IND) applications and amendments.
Provide guidance and support to other in‑house units in the preparation or review of manuals, training guidelines, and similar documentation.
Serve as a resource for new medical writers, offering direction, feedback, and support as needed.
Theradex Oncology is a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe and Asia. Their focus is cancer, understanding the science behind each potential cancer therapy and the challenges of moving therapies from mice to man.
Works collaboratively within CMC regulatory and technical operation teams on writing projects for early, late-stage development, and commercial programs.
Contributes to drafting, reviewing, and finalizing CMC content and regulatory documents such as Module 3 sections for INDs, BLAs, and MAAs.
Plans and manages writing projects, ensuring documents meet quality standards and adhere to corporate SOPs and evolving global regulations.
Iovance Biotherapeutics aims to be the global leader in developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are an innovative biotechnology company pioneering a transformational approach to treating cancer by harnessing the human immune system.
Monitor the progress of clinical studies at investigative sites or remotely, ensuring trials are conducted per protocol, SOPs, and regulatory requirements.
Conduct monitoring visits, review source documentation, verify data, and ensure accurate reporting of adverse events and protocol deviations.
Develop trial materials, contribute to SOPs, and maintain high-quality monitoring documentation and reports in required timelines.
Orca Bio is a late-stage biotechnology company developing next-generation purified cell therapies to redefine the transplant process for blood cancer patients. The company fosters a fast-paced, collaborative, and entrepreneurial start-up culture with a passionate team driven by core values and a mission to improve patient lives.
Develops/maintains project timeline inclusive of startup through completion.
Drives development, approval, and distribution of study-related documents and study tools.
Manages distribution, collection and tracking of regulatory documentation.
Penumbra, Inc. is a global healthcare company focused on innovative therapies. They design, develop, manufacture, and markets novel products and has a broad portfolio that addresses challenging medical conditions.
Partner with Clinical Operations leadership to support clinical trial execution.
Lead site feasibility, selection, initiation, and greenlight activities for clinical trial sites.
Provide guidance and oversight to CRAs, including trip report review and training support.
Immatics is dedicated to making a significant difference in the lives of cancer patients. They are a global frontrunner in precision targeting of PRAME, found in over 50 cancers, with cutting-edge science and a strong clinical pipeline.
Own a portfolio of jurisdictions and act as the operational lead for everything regulatory that happens in those geos.
Partner closely with engineering and product to drive requirements development and shape how registration and compliance products are customized per market.
Translate policy and legal direction into operational playbooks and translate field signal back into product priorities.
Breezy is a global, two-sided marketplace company.
Enter clinical trial data into EDC systems accurately and on time per study protocols and sponsor requirements.
Perform routine data quality checks, identify and resolve discrepancies, and support query resolution to keep studies on track.
Track data entry timelines across multiple concurrent studies and support database lock activities with organized, audit-ready documentation.
Profound Research partners with community physicians to offer clinical trials as a therapeutic option for their patients, handling all infrastructure and operations. It is a collaborative organization that invests in professional growth and offers competitive benefits.
Coordinates activities related to human subject research.
Assists in recruitment and screening, reviewing databases and records.
Ensures data collection and adherence to protocols, communicating with sponsors.
The University of Rochester is committed to the ideal of Meliora - Ever Better, with values like equity, leadership, and integrity. As one of the world’s leading research universities in western New York, Rochester has a tradition of breaking boundaries through learning and questioning.
Plan, lead, and manage clinical trials, developing comprehensive project plans for timelines, budgets, and deliverables.
Ensure regulatory compliance by working with the Compliance Team and preparing for audits, adhering to GCP guidelines and company SOPs.
Serve as a primary communication point for sponsors and internal teams, providing regular updates and building client relationships for future business.
Paradigm Health is a company rebuilding the clinical research ecosystem by enabling equitable patient access to trials and enhancing trial efficiency. The team, backed by leading investors like ARCH Venture Partners, is multidisciplinary and committed to creating equitable access to clinical trials for any patient, anywhere.
Support Omada’s research program by coordinating day‑to‑day study operations for assigned protocols.
Contact study participants to facilitate timely, complete and accurate participation in study.
Maintain accurate study documentation and trackers so the team has a current view of study status.
Omada Health is reverse engineering the way healthcare is delivered in America, putting the space between doctor visits at the center of care. Omada has served more than two million members since launch across 2,000+ employers and strives to build an inclusive culture.
Partner with Regulatory leads to manage regulatory filing subteams and subteam operations.
Develop and maintain high level and detailed regulatory timelines that utilize project management software tools.
Resolve submission execution issues by managing contingency plans with cross-functional stakeholder input and resolving delays or potential delays.
Ultragenyx is a biopharmaceutical company committed to addressing unmet medical needs in the field of rare diseases. With a focus on innovation and patient-centricity, they strive to develop life-changing treatments and improve the lives of patients and caregivers.
Use SQL to pull, analyze, and interpret data, sizing and prioritizing issues.
Serve as a collaborative partner to Legal, Engineering, Supply, and Scaled Operations teams.
Identify and implement opportunities to simplify, streamline, and automate regulatory workflows.
Breezy is a company that is seeking a data-driven, entrepreneurial operator to join its Regulatory Operations team supporting two emerging business verticals inside a global technology platform. They are looking for someone who values curiosity, learning, and pragmatic innovation.
Support US state privacy law operations and enhance the client privacy program by assisting with implementing and operationalizing state and federal privacy law requirements.
Ensure timely completion of consumer privacy requests by supporting Data Subject Access Request (DSAR) processes and privacy-related issue resolution.
Maintain privacy compliance documentation and support ongoing privacy initiatives by collaborating cross-functionally to integrate privacy practices into business processes.
The company utilizes Breezy HR software for recruitment but specific business details are not disclosed in the job posting. Based on the role's focus on privacy compliance, it likely operates in a regulated industry handling consumer data, but size and culture are unspecified.