Help manage the day-to-day technical aspects of the established compliance program, including administration of the compliance training program and supervision of the compliance process review program.
Work closely with employees of each business unit, including senior management, to foster a team approach to managing compliance risk by strengthening internal controls and employee training.
Plan and conduct compliance reviews, prepare detailed reporting of findings, and ensure corrective action is taken while monitoring new and pending changes to laws and regulations.
First Bank & Trust is an independent community bank that contributes to the success of its local communities. The company employs almost 700 people and fosters a family-like, collaborative culture where employees are part owners through an ESOP.
Author, maintain and implement study-specific Clinical Quality Audit Plan(s) for assigned clinical program(s).
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, they are developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.
Assist in preparation and review of policies, procedures, and agreements.
Research diverse topics; review internal operations and practices to ensure compliance.
Collaborate with teams across marketing, cybersecurity, IT, product, finance, and business functions.
Topstep is an engaging company that exists in both remote and hybrid environments. They foster a culture of collaboration by keeping cameras on during meetings and maintaining a robust Slack environment for communication.
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.
Develop and execute medical affairs strategies aligned with company goals.
Build and maintain strong relationships with HCPs, KOLs, and patient advocacy organizations.
Collaborate with the CMO to establish high-integrity, compliant processes for HCP and KOL engagement.
Capricor Therapeutics is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. Every program reflects their commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most.
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.
Develop and execute QC strategy to support clinical product testing and commercial launch.
Lead and provide oversight of analytical method validation and lifecycle management.
Lead complex investigations and champion data integrity principles.
Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka is building its core team and is looking for top talent who are passionate about making a difference.
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.
Execution of the risk-based branch exam program in FINRA-registered and non-registered Private Client Group branches across the country.
Clear communication of all exam findings to branch management, exam managers and compliance leadership.
Ensure risks and adverse trends are identified and escalated.
Raymond James is a diversified financial services company providing wealth management, capital markets, asset management, banking and other services to individuals, corporations and municipalities. They have locations and subsidiaries across the United States, Canada, the United Kingdom and Germany.
Strategically orchestrate the end-to-end journey for complex key account customers globally.
Partner with Marketing, Sales, and Product Management to ensure CX strategy supports objectives and product launches.
Ensure all customer touchpoints comply with global healthcare regulations and cGMP.
LGC delivers Science for a Safer World through research and impactful disease diagnosis. They foster an environment that encourages scientific advancement, cultivating passion for discoveries and role development.
Develop a deep understanding of customer workflows.
Champion Qualio's agentic compliance solutions.
Become an in-house expert on Qualio's product.
Qualio is an agentic quality and compliance management platform that helps regulated organizations get products to market faster with reduced risk. The Qualio team is an all-remote, globally distributed workforce with teammates in over ten countries.
Lead day-to-day oversight of commercial manufacturing operations, process engineering activities, and continuous improvement initiatives.
Drive process optimization, troubleshooting, scale-up, PPQ, validation, and lifecycle management activities for commercial products.
Support regulatory CMC strategy, including development and review of Module 3 CTD submissions and health authority responses.
Deciphera Pharmaceuticals is committed to improve the lives of people with cancer. They offer a dynamic team environment and opportunities for personal and professional growth.
Provide daily operational and compliance support for import and export processes of traded goods.
Maintain internal controls and procedures to ensure compliance with trade regulations.
Serve as subject matter expert for general trade compliance and customs relations.
LGC Biosearch Technologies delivers mission critical genomics to its diverse customer base in molecular diagnostics, pharma/biotech, and agrigenomics. The company has manufacturing sites across the US, UK, Germany and Denmark, and plans to continue growing with a collaborative team culture.
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.
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.
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.
Collaborate closely with the Merchant Risk team to identify, assess, and mitigate compliance risks associated with merchant and platform partners.
Review and approve financial services marketing materials to ensure they comply with regulations and industry standards.
Work cross-functionally with departments such as Compliance, Legal, Risk, and Revenue to complete reviews and address compliance issues and their root causes.
Affirm is reinventing credit to make it more honest and friendly, giving consumers the flexibility to buy now and pay later without any hidden fees or compounding interest. They are a remote-first company, with a dedicated group of professionals committed to helping Affirm scale, innovate, and provide outstanding products.
Responsible for CMC regulatory activities globally for assigned projects and adapts swiftly to changing events and priorities.
In charge of CMC strategy development, with management support, for CMC submission dossiers to support lifecycle management.
Ensures that information submitted in support of life cycle maintenance applications meets regional requirements, allowing maximum flexibility in supply, manufacturing and quality.
Alphanumeric recruits for one of the largest pharmaceutical companies in the world, headquartered in Montreal, Quebec. They are helping them find a Responsable des affaires réglementaires internationales CMC to work remotely in Quebec or Ontario.
Contribute to the design of early/late-stage protocols across multiple therapeutic areas.
Develop and write statistical analysis plans, and perform statistical analyses for interim and final reports.
Support submission activities, including design, analysis and reporting of integrated summaries for safety and efficacy.
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. With over 4,000 professionals in more than 20 countries, they focus on quality, professional development, and a supportive culture.