Compliance

• At Rho, we are not just a typical CRO; we inspire innovation in the life sciences. Join our dedicated team where curiosity fuels progress, collaboration is encouraged, and every day brings an opportunity to impact the world of clinical research.
• Provide strategic and tactical leadership to Rho clients and project teams in support of our clients’ interdisciplinary pharmaceutical, biologic, and medical device development programs and regulatory submissions.
• Serve as an integrated product development and regulatory expert at Rho, responsible for product development activities and services required to support the development programs and regulatory submissions of Rho’s clients, including gap analyses, strategic planning, development of integrated regulatory and clinical strategies and development plans, design of clinical studies, and authorship and review of study protocols, study reports, and regulatory submissions.
• On behalf of Rho’s clients, lead integrated pharmaceutical, biologic, and medical device product development programs consisting of clinical, nonclinical, chemistry, manufacturing and controls, and regulatory components.
• Provide leadership, guidance, and support to teams, programs, or projects of large scope, as well as to the Program Management discipline within the company.
• Mentor and advise staff in areas of expertise by providing strategic and tactical guidance to team members, creating a strong sense of team unity and team identity, and providing regular and ongoing positive and corrective feedback to team members.
• Proactively identify risks and critically analyze problems affecting the programs and develops contingency plans as needed.
• Facilitate achievement of strategic goals for a program.
• Monitor ongoing progress of key deliverables against Global Integrated Product Development Plan goals, including the identification of potential risks and contingency plans.
• Ensure effective, accurate and timely communication of key issues and progress to project stakeholders and senior management.
• Manage the strategic, regulatory authorship, biostatistical, and data submission components of regulatory submissions projects including INDs, IMPDs, IDEs, NDAs, BLAs, MAAs, and PMAs or portions thereof and is comfortable with all requirements related to electronic submissions.
• Author Integrated Summaries of Safety, Integrated Summaries of Efficacy, and other complex regulatory documents.
• Develop and review clinical study protocols, investigator’s brochures, clinical study reports, and other key clinical development documents.
• Lead the planning, preparation, and conduct of regulatory authority meetings, and participates in discussions with regulatory authorities as appropriate.
• Manage scope of work, budget, and timelines for external vendors, including consultants, external medical writers, nonclinical toxicology houses, and other vendors.
• Moderate regulatory authority meetings.
• Participate in business development activities, including assisting in the identification and assessment of new opportunities, representing Rho at conferences and meetings, and conducting capture activities for anticipated proposals; serve as a proposal leader for commercial proposals with specific responsibility for the development and articulation of the technical strategy sections of the proposal; provide guidance and input to the budgets and business submissions of proposals.
• Mentor other technical leads in business development and proposal creation activities.

Associate Director – Regulatory Strategy

Administration

• Serve as subject matter expert on federal award terms (contract and cooperative agreement) for review, drafting, and modification of all types of agreements related to federally funded projects as well as teaming, consulting, sponsored research, clinical site, vendor, and other services-related agreements, using corporate templates as appropriate under the circumstances.
• Engage with capture and proposal teams supporting proposal development and pre-award negotiations: review and analyze RFP/RFA terms and conditions, participate in risk assessments, and assist the pre-award team in representing Rho’s interests during contract and cost/price negotiation.
• Provide post-award support and expertise to internal teams by negotiating modifications; interpreting, educating, and advising internal teams regarding award requirements; attending Government customer and internal program/project meetings; and identifying and helping to successfully resolve issues or changes that may arise during project performance.
• Liaise with Government contracting and grant administration staff for post-award authorization requests, modifications, reporting, and compliance activities.
• Collaborate with internal and external subject matter experts to resolve issues affecting company compliance, satisfaction of award requirements, and Rho and customer objectives.
• Build and maintain effective and collaborative working relationships with internal and external customers in support of Rho’s business objectives.
• Maintain knowledge of the Federal Acquisition Regulations (FAR), contracting methods, and contract terms and conditions and regularly advise management of contractual rights and obligations, escalating complex risks appropriately.
• Maintain knowledge of federal cooperative agreement terms and conditions, particularly those contained in the NIH Grants Policy Statement.
• Manage and document contract close-out activities and deliverables in compliance with contract clauses and applicable regulations.

Director, Federal Award Administration

Analyst

• Work with P&C leads to support development of client documents
• Collaborate with Rho operational team members and Business Development to develop high-quality client documents including budgets, assumptions, and scope of work text, in response to commercial sponsors' Request for Proposals (RFPs)
• Prepare RFPs for services from 3rd party vendors (e.g. electronic data capture, laboratory services, ePRO, or IP Management) including outlining scope of services, responsibilities, and other project-specific requirements to ensure alignment with project and client needs
• Prepare project specific contract documents, which accurately reflect the scope of services and agreed upon budget
• Support initiatives by researching special topics and gathering information and materials from internal stakeholders
• Assist with a variety of content development and administration tasks

Associate Proposal and Contract Analyst

Accountant

• Assist in month-end and year-end close process, including preparation of journal entries, reconciliations, accruals, and financial statement analysis.
• Ensure accuracy and integrity in financial reporting and compliance with US GAAP, tax laws, regulatory requirements and company policies.
• Prepare and analyze financial statements, identifying trends and variances.
• Collaborate with internal teams to ensure the completeness and accuracy of financial data.
• Assist in the development and implementation of financial policies and procedures to improve efficiency and compliance.
• Manage and respond to audit requests, ensuring timely and accurate submission of financial data.
• Assist in tax filings, regulatory reporting, payroll reporting and compliance with local, state, and federal laws.
• Identify and implement process improvements, automation opportunities, and best practices to enhance operational efficiency.
• Stay updated with changes in accounting regulations, financial reporting standards, and industry best practices.

Senior Accountant

Manager

• Overseeing the clinical monitoring team within Europe, ensuring compliance with regulatory standards, protocols, and quality expectations.
• Managing a team of Clinical Research Associates (CRAs) and collaborating with leadership to achieve project objectives.
• Optimizing monitoring processes and fostering a culture of continuous improvement.
• Providing mentorship and support to CRAs; meeting routinely to discuss development and performance.
• Supporting assessment of clinical monitoring employee resources to meet client expectations.
• Reporting monthly on CRA staffing development progress and addressing any gaps or needs.
• Performing periodic monitoring field assessment visits of CRAs to ensure compliance and performance standards.
• Providing dynamic mentorship and serving as a technical expert for employees and clients.
• Collaborating with project teams to ensure customer satisfaction and high-quality deliverables.

Associate Director – Regulatory Strategy

Director, Federal Award Administration

Associate Proposal and Contract Analyst

Associate Proposal and Contract Analyst

Senior Accountant

Manager, Clinical Monitoring – EU