Assoc General Counsel - EU​/Data Privacy - Clinical & Commercial

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Regular Legal & Regulatory All Virtual Locations, Home Based Position, USA, Remote, US

As a pharmaceutical support industry leader, UBC is devoted to empowering health solutions for a better tomorrow. We take pride in improving patient outcomes and advancing healthcare. At UBC, we provide services to enhance the entire drug development process and commercialization lifecycle
- From clinical trial support to real-world evidence generation.

Embark on a rewarding career journey with UBC! Grow your career while making a meaningful impact on the world around you. UBC fosters a culture built on our Core Values being:
Collaborative, Conscientious, Curious, Consultative, and Compassionate. We believe in an inclusive workplace that fosters creativity.

If you are seeking a career that will challenge, inspire, and reward you, join us at UBC!

Brief Description
:

The Associate General Counsel will provide (a) primary strategic legal counsel on clinical and commercial (i.e., patient access and support, and copay, programs) and healthcare regulatory matters, including US and EU clinical trials, and (b) provide support to UBC’s Data Privacy and other Legal team members with regard to privacy and data protection, both with a focus on supporting regulated biopharmaceutical, clinical research, and commercial healthcare services, and operations.

This role will also advise cross-functional business, compliance, clinical and commercial operations, EU (and as necessary, US) human resources and employee relations, information security, quality, and other UBC stakeholders and teams on complex legal and regulatory issues.

The successful candidate will bring broad and deep clinical trial and commercial regulatory knowledge and sound judgment, a firm understanding and experience with privacy and data protection (sufficient to support Privacy and Legal team functions and, as needed be a primary source of counsel in advising business-side stakeholders), and practical knowledge of EU employment law, including multi-jurisdictional employee relations, workforce transitions, employee privacy, works council or employee representative engagement, and employment-related data protection issues.

The role requires comfort operating in a highly regulated and dynamic environment and partnering closely with business stakeholders to manage legal risk while enabling responsible innovation, compliant clinical research activities, and legally sound workforce decisions.

Specific job duties:

• Serve as a primary/lead legal adviser with respect to the Company’s clinical and commercial biopharma services operations, regulatory, pharmacovigilance, real-world evidence, data management, and business teams on legal and regulatory issues arising in clinical and commercial CRO/biopharma services programs.
• Provide legal support for clinical trial and commercial program regulatory documentation and operational processes, including informed consent language, authorization/enrolment form language, subject recruitment materials, investigator/site communications and agreements, trial data use, and cross-border data transfer considerations.
• Support Privacy and Legal teammates with respect to, and serve as a primary resource in, advising business stakeholders on, compliance with privacy and data protection frameworks, including GDPR, UK GDPR, HIPAA state consumer privacy laws, health data privacy requirements, breach notification laws, and other applicable federal, state, and international requirements.
• Monitor legal and regulatory developments…