The role supports the US and International Privacy Leads and acts to support the Company’s Global Privacy Program (with a focus on LATAM) to ensure that affiliates and business stakeholders are given a framework to secure compliance with complex privacy laws and adherence to industry best practices. The role is responsible for supporting internal privacy procedures and processes and responding to business and stakeholder inquiries as assigned. Responsibilities may be for specific program elements and processes and/or regional in focus.
The responsibilities include, but are not limited to:
Privacy Program Management - Support US and International Privacy Leads, and act as a resource for functional and affiliate employees, to ensure the Company is executing in compliance with complex laws, including the GDPR, e-Privacy Directive, LGPD, Clinical Trials Regulation, HIPAA, FDA and Common Rule and local data protection laws.
Business Consultation - Provide practical and timely advice to internal clients on specific projects to design processes in compliance with applicable data protection requirements, while addressing legal risks and protecting the Company’s integrity and reputation. Execute and manage key privacy risk assessment processes including Vendor Risk Assessments, Data Protection Impact Assessments and contract reviews to ensure the proper diligence and privacy-by-design elements are considered and incorporated into Biogen’s business practices and initiatives.
Privacy Operations - Ensure timely processing of inquiries and notices from stakeholders, data subjects and vendors. Ensure these engagements are researched, tracked and driven to resolution in a timely manner. These include data subject requests, marketing opt outs, notices of data incidents and potential data incidents, questions related to clinical trial site setup, process questions. Triage the privacy mailbox and communicate with external stakeholders who contact the Company related to privacy.
Monitor and Audit - Support ongoing measurement and auditing on overall effectiveness of the Privacy office and execution of privacy policies and standards, both internally and by third party vendors.
Requirements
Significant experience providing privacy advice; strong preference for pharmaceutical industry or related experience (e.g. CRO, pharma vendor); experience working within a sophisticated enterprise with global operations; specialized knowledge of statutes, regulations and guidance concerning data protection in relevant jurisdictions across the globe; ability to constructively counsel and influence clients in making the right decisions; ability to balance risks in ambiguous and complex situations; demonstrated teamwork and collaboration skills; demonstrable experience taking ownership of assigned activities and providing timely, actionable advice; high ethical standards and very good legal judgment; hands-on problem-solving with strong business acumen and common sense; excellent communication skills and can effectively explain complex concepts in simple ways.
- Undergraduate degree in law or related area
- Bar or equivalent admission in a relevant jurisdiction preferred
- Data protection certification (CIPP, or CIPT from IAPP or a similar accredited body) preferred
- 5-7 years’ experience in jobs of increasing responsibility in legal/compliance/regulatory; 2-4 years’ related experience in privacy and data protection; life sciences/life sciences-related privacy role preferred; full professional fluency in English (other languages desirable, particularly Portuguese and/or Spanish)
- Based in Mexico
Biogen
Biogen is a global biotechnology company focused on discovering, developing, and delivering treatments for patients with neurological and neurodegenerative diseases.
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