Regional Regulatory Manager

🕒 Setembro 18

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 10%

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Flourish Research

SiteLinkedInTodas as Vagas

201 - 500 funcionários

🏥 Saúde

💊 Farmacêutico

Healthcare • Pharmaceuticals

A Flourish Research é uma rede nacional de estudos clínicos com vários sites e uma operadora de locais que conduz estudos clínicos pagos em todo os Estados Unidos. Ela oferece soluções completas de pesquisa clínica — desde estudos de fase I, os primeiros em humanos e iniciais em pacientes, até ensaios de fase II-IV — e faz parcerias com patrocinadores farmacêuticos e CROs para acelerar a execução dos ensaios utilizando sites próprios, pesquisadores experientes, tecnologia de recrutamento e acesso a populações de pacientes diversas e sub-representadas. A empresa opera dezenas de locais de clínicas em muitos estados dos EUA, especializa-se em áreas terapêuticas como cardiometabólico, oncologia, neurociência, doenças infecciosas e vacinas, e enfatiza o cuidado centrado no paciente, alta retenção e entrega de estudos com qualidade regulatória.

Descrição

• Oversee, manage, and coordinate regulatory documents and activities throughout clinical research studies across regional sites • Ensure compliance with company SOPs, policies, federal regulations, medical ethics, ICH, GCP, IRB requirements, and sponsor protocols • Work closely with site leadership, principal investigators, site staff, sponsors, CROs, and IRB staff • Provide guidance and support to ensure regulatory requirements and deadlines are met • Manage employee CVs and maintain current licenses and certifications on file • Serve as regulatory lead for audits and inspections • Oversee regulatory start-up timelines and staff for awarded clinical research trials • Prepare, submit, and maintain regulatory documents, including IRB submissions, amendments, and renewals • Provide administrative and regulatory guidance across the assigned region • Establish communication channels and disseminate key information among regulatory teams, site management, delegates, and RDO • Collaborate with management on staff development, department structure, and employee retention • Develop strategies, systems, and tools to improve regulatory efficiency and quality • Serve as regional subject matter expert • Manage assigned team activities to improve organizational performance • Lead, mentor, manage, and train team members • Assist with screening, interviewing, and hiring team members • Conduct annual performance reviews and foster continuous improvement • Identify trends and contribute to process improvement initiatives • Perform disciplinary procedures when necessary • Manage team time-off requests and schedules to ensure adequate staffing • Abide by HIPAA regulations and maintain sponsor confidentiality • Create error-free written documents and reports • Perform duties in a time- and cost-effective manner • Represent Flourish Research professionally when interacting with staff, clients, and vendors • Perform additional duties as assigned • Travel may be required up to 50% • Participate in participant care and monitor/sponsor customer service • Work occasional evening and weekend schedules

🎯 Requisitos

• High School Diploma required • College degree preferred, but not required • Minimum of 5+ years’ experience in clinical or biological research • Minimum of 3 years in the department plus 2 years in a related role within the clinical research industry • Exceptional knowledge of clinical research methods • Strong management and leadership skills • Demonstrated ability to collaborate and align with operations • Excellent written and oral communication skills • Moral and ethical decision-making when interacting with patients, sponsors, IRB representatives, physicians, staff, and employees • Strong work ethic and commitment to accuracy and quality • Ability to develop and implement departmental initiatives • Ability to identify and implement process improvements • Ability to build and foster relationships across teams • Ability to serve as preceptor, mentor, and subject matter expert in the department • Strong critical thinking, decision-making, and sound judgment • Excellent computer skills, including Office365 products • Strong problem-solving, risk assessment, and impact analysis abilities • Demonstrated experience in process improvement • Flexibility and ability to multitask and prioritize competing demands • Ability to think independently and influence when appropriate

🏖️ Benefícios

• Health, dental, and vision insurance plans • 401(k) with a 100% employer match on the first 4% of employee contributions • Tuition reimbursement • Parental leave • Employee referral program • Employee assistance program • Life insurance • Disability insurance • Generous PTO plan covering vacation, sick, personal days and 8 paid holidays