Genentech discovers, develops, manufactures and commercializes treatments for patients with serious and life-threatening medical conditions. Backed by North Carolina Biotechnology Center.
About the role
Proactively providing strategic business and legal advice and education related to the following: FDA laws, regulations and guidance and other laws and regulations governing the research and development of biotech/pharmaceutical products;
More about this role
As a member of the Roche Global Legal Pharma’s R&D Legal team, this Senior Corporate Counsel role will support global business functions within Roche’s Pharmaceutical division, such as Research and Early Development, Clinical Operations, Global Product Development, and Medical Affairs, by providing strategic legal advice to advance the company’s pipeline; this pipeline includes drug, device, digital and integrated solutions.
The Opportunity
Proactively providing strategic business and legal advice and education related to the following:
FDA laws, regulations and guidance and other laws and regulations governing the research and development of biotech/pharmaceutical products;
Early research through interventional trials, including drug, biologics, advanced therapy medicinal product, software as medical device, and biomarker and omics research,
Use of AI in research and development activities
US and global data privacy
Real World Data and non-Interventional studies
Data Sharing
Human subject protections
Advising, drafting, and negotiating complex research collaborations and data sharing agreements with academic institutions, healthcare institutions, government entities and other...
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