• Coordinate all aspects of regulatory and client audits (i.e., pre-site deliverables, mock audits, on-site visits, logistics, and written responses to audit reports and corrective actions) and coordinate across times to document and track completion to ensure audit success. • Synthesize audit-related information (i.e., scope, findings, recommendations, corrective action plans, and status) and provide Compliance and business operations leadership written and oral reports of ongoing and completed audits. • Simultaneously manage multiple audits and collaborate across multiple business areas to communicate gather necessary information within assigned due dates. • Develop compliance communications. • Problem solve and work closely with business partners on issue resolution. • Research, understand, and articulate regulatory and contractual requirements. • Educate business partners on regulatory audit processes as needed. • Manage, track and report data related regulatory and client audits and CAPs. • Coordinate with Legal Counsel as needed. • Perform additional duties as requested or required by management.

• Provide strategic oversight for Amgen’s global compliance platform (C3), ensuring the system effectively supports compliance program requirements and evolving business needs. • Define and drive the platform roadmap in partnership with Technology and compliance leadership, prioritizing enhancements that improve usability, scalability, and compliance oversight. • Establish and maintain governance structures, standards, and operating procedures for the platform, ensuring consistent global use and alignment with compliance policies and processes. • Monitor platform performance, adoption, and risk indicators to ensure the system continues to support effective compliance program execution. • Serve as the business product owner for the platform by governing enhancement intake, prioritization, and capability roadmap development in partnership with Technology teams responsible for configuration, development, and deployment. • Identify and prioritize opportunities to streamline compliance workflows, simplify user experience, and improve operational efficiency within the C3 platform, partnering with Technology teams to implement approved system enhancements. • Lead cross-functional initiatives to optimize platform processes, reduce manual work, and enhance system capabilities. • Ensure platform processes remain aligned with evolving regulatory expectations, compliance policies, and industry practices.

Company Overview TestPros is a successful and growing business, established in 1988 to provide Information Technology (IT) technical support services to a wide range of Commercial and U.S. Federal, State, and Local Government customers. Our capabilities include Program Management, Program Oversight, Process Audit, Intelligence Analysis, Cyber Security, NIST SP 800-171 / CMMC Assessment and Compliance, HIPAA, Privacy, Computer Forensics, Software Assurance, Software Testing, Test Automation, Section 508 and WCAG Accessibility Assessment, Localization Testing, Independent Verification and Validation (IV&V), Quality Assurance (QA), Compliance, and Research and Development (R&D) services. TestPros is an Equal Opportunity Employer. TestPros delivers innovative independent IT assessment solutions to critical challenges facing the nation and the world. We support the U.S. Federal Government and Commercial clients within the continental USA. TestPros is dedicated to making lives better, safer and more secure. Focus: HIPAA Assessment and Consultation Start: April 2026 Type: Part-time consulting Overview We are seeking a HIPAA Compliance Assessor / Consultant to support independent assessments of HIPAA compliance. This role will evaluate how websites, apps, or platforms collect, use, and protect user data, with a focus on minors/children. Key Responsibilities - Identify Electronic Protected Health Information (ePHI): Locate all systems holding sensitive data. - Identify Threats and Vulnerabilities: Determine potential, reasonably anticipated threats. - Assess Security Measures: Evaluate current safeguards. - Determine Likelihood and Impact: Evaluate the probability and impact of potential breaches. - Document and Prioritize Findings: Create the formal report and risk mitigation plan. Required Skills / Experience - 5+ years of experience with HIPAA Assessments and Reporting - 5+ years of experience with HIPAA guidelines, such as: - NIST Special Publication 800-66 Rev. 2: Implementing the HIPAA Security Rule - NIST Cyber Security Framework to HIPAA Security Rule Crosswalk - Health Information Trust Alliance (HITRUST)​​​​​​ - Hands-on experience conducting: - Privacy assessments / audits - PIA / DPIA - Strong understanding of: - Data flows & data lifecycle - User data handling in web/mobile applications - Experience reviewing: - Consumer-facing systems (apps, websites) - Consent, transparency, and privacy controls - Ability to translate regulations into practical findings and recommendations Nice to Have - Background in GRC, cybersecurity, or product compliance - Certifications such as: - CIPP, CIPM, CISM, or similar Work Setup - Part-time (consulting basis) - 1099 or Corp-to-Corp - Flexible hours - Project-based (initial assessment engagement) TestPros, Inc. is an Equal Opportunity Employer. EEO Statement All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, marital status, age, national origin, protected veteran status, or disability. VEVRAA Federal Contractor.

Due to ongoing global expansion, Indero is looking to hire a Regulatory Affairs Specialist. In this position, you will be responsible for preparation and submission of part I and/or part II following EU CTR and other applications created within or outside of the company to ensure documentation comply with applicable regulations and guidelines and contractual timelines are met. You will provide leadership for assigned projects regarding all regulatory activities that lead to start up of clinical trials. Responsibilities: - Preparation of regulatory documents, CTA packages, and submissions in assigned countries to ensure high quality standards - Coordination of regulatory timelines and deadlines for all assigned projects planned for CTIS submissions. Includes oversight of EU (mainly), APAC, and North America submissions. - Review of regulatory documents and submissions created outside of the company by subcontractors (eg, partner CROs, regulatory vendors) to ensure high quality standards before submission to CTIS - Point of contact for Sponsors and subcontractors/project management teams for all aspects related to study regulatory submissions - Preparation or review of country specific Patient Information Sheet/Informed Consent form documents. - Preparation or review of study-specific templates of regulatory forms. - Manages translation requests with vendor. - Regulatory support and advice to project teams and key internal/external customers on local requirements and EU submission strategy and technical expertise - Maintain high level knowledge about EU CTR and EU/EEA countries local requirements in the area of company interest. - Maintain the regulatory intelligence database - Participation in Kick-off meetings, audits, and other project related meetings according to the company / client needs Requirements Education - Bachelor's degree (or equivalent) in a scientific discipline Experience - Minimum of 2-3 years of clinical research experience (in CRO or Pharma) working in Poland regulatory affairs is required - Experience in initial CTA is essential - Experience in a sponsor facing role is an asset - Previous experience with CTIS is an asset - Hands-on experience preparing, reviewing, and submitting regulatory documentations Knowledge and skills - Excellent knowledge of applicable EU regional / national country regulatory guidelines (such as Poland, Spain, Germany, France, Netherlands) - Excellent knowledge of GCP and ICH standards - Fluency in English with excellent oral and written skills, required - Additional languages represent an asset - Excellent organization and communication skills, great attention to detail - Ability to organize own work, prioritize different assignments, and work under pressure; - Versatile and comfortable in a multitasking environment; - Respect established timelines, expectations, priorities, and objectives; Our company The work environment At Indero, you will work with brilliant and driven professionals. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. As a Regulatory Affairs Specialist you will be eligible for the following perks: - Permanent full-time position - Flexible schedule - Vacation - Home-based position - Ongoing learning and development About Indero Indero is a CRO specialized in dermatology and Rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in Romania. Description de poste null Profil recherché null Notre entreprise null