Senior Legal And Compliance Counsel – Home Based

Within a clinical trial, recruiting patients to participate is frequently the most difficult and time-consuming activity. To conquer this, AutoCruitment has developed a targeted, direct-to-patient online marketing platform to recruit, screen, and refer patients for clinical trials and specialty procedures.

We are currently looking to strengthen our team at AutoCruitment and are seeking an experienced Senior Legal and Compliance Counsel. This role is focused on providing legal, compliance support, and counsel on various matters to a leading provider of technology-enabled patient recruitment services, serving the clinical research and broader biopharmaceutical industry. Your work will focus on legal and compliance matters, in particular US and international data protection and privacy laws (including GDPR compliance), assistance with compliance surveys and audits, contracting, and providing general support as needed for the Legal and Compliance functions.

Job Duties

As the Senior Legal and Compliance Counsel, you will be reporting directly to the General Counsel and Chief Compliance Officer. General responsibilities include:

• Partnering with the General Counsel and Chief Compliance Officer, and other internal stakeholders, to provide advice on legal, regulatory, and compliance issues, and drive projects to completion.
• Leading vendor compliance and vendor compliance surveys.
• Managing and providing guidance on the internal CAPA process and business continuity plan.
• Leading internal compliance audits across departments with a focus on privacy and data protection.
• Leading the completion of both initial and annual client-requested compliance surveys and the management of customer compliance and regulatory audits.
• Developing a deep understanding of the business and operational goals while developing and maintaining positive relationships with external customers and internal clients at all levels of the organization.
• Providing general legal ‘overflow’ support on customer and commercial transactions, and other general legal support as needed.
• Staying current on regulatory landscape and requirements (data privacy, data retention, etc)
• Identifying specific training needs and internal SOPs/practices/policies in the areas of data privacy and security, and with data breach investigations as needed.
• Providing legal support and regulatory guidance in the areas of US and international privacy and data protection law and compliance (including GDPR compliance). This will include advising on contractual provisions in customer contracts, privacy-related policies, consent forms, standard operating procedures (“SOP”s), and providing general legal advice in the areas of data privacy and security.
• Identifying business and legal risks while providing solutions to balance legal issues and business objectives.

Education and Experience

• Comprehensive knowledge of EU and U.S. data protection regulatory requirements is required.
• International Privacy Professional Certification or the equivalent is preferred.
• Technology experience in the healthcare industry, in particular with software-as-a-service, contract research organizations, pharmaceutical companies, or other healthcare organizations is a plus.
• Experience with clinical research and the associated compliance requirements is highly preferred.
• U.S. J.D., EU LLB, or an equivalent degree is required.
• AutoCruitment is looking for a licensed attorney who has 5+ years’ experience within a legal or compliance role in the field of privacy and data protection.

Knowledge, Skills, and Abilities

We are looking for someone who is:

• Strong in the area of verbal and written communication.
• Committed to excellence, collaboration, innovation, integrity, and who practices humility; these are the AutoCruitment values.
• Excitement for the mission: Improving lives by connecting people with clinical research, anytime, anywhere, accessible to anyone
• Knowledgeable and understanding of technology-related law and clinical research.
• Results and customer oriented, organized, and able to prioritize.
• Willing to travel occasionally if needed.
• Practical when it comes to business judgment and the ability to qualify actual practical risk.
• Able and willing to make rational but bold decisions under time pressure.
• Comfortable with complicated matters and able to work independently.