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General Counsel
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provided
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Melinda Burrows
Deputy General Counsel
- Litigation and
Compliance, Progress
Energy Service Company
LLC

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Counsel Jobs > Senior Corporate Counsel, Clinical Development Legal Job in New York > Senior Corporate Counsel, Clinical Development Legal

In House Legal Job Listings

YOUR WINDOW TO A WORLD OF OPPORTUNITIES

Senior Corporate Counsel, Clinical Development Legal

Refer job# BBIE139532

Senior Corporate Counsel, Clinical Development Legal The candidate will provide legal support to the Clinical Development Legal (CD Legal) team on matters relating to clinical research collaborations, registry research, clinical data transfer, and other clinical development transactions. Will also focus on legal requirements applicable to the use of digital approaches and social media in clinical trials, as well as other clinical trial innovation matters. The position will primarily support Global Product Development (GPD) organization, responsible for clinical development, clinical trial conduct, and oversight of vendors developing mobile applications and other digital tools for use in clinical research. This role will also work on digital health initiatives across the team, including Worldwide Research and Development (WRD), Business Technology (BT), Strategy and Commercial Operations (StratCo), Medical and Corporate Affairs. Provide regulatory compliance advice to the Clinical Innovation team within Global Product Development, the Patient Engagement team within the Medical division and other groups in involved in clinical innovation activities. Assist with the development and implementation of digital and data initiatives and provide transactional support for supported clinical trials globally, such as mobile applications, use of social media for subject recruitment, electronic informed consent (eConsent), and integration of electronic medical records and clinical trial records (eSource). Support GPD, and other stakeholders within Medical, Business Development and other stakeholders with respect to diligence, initiation, negotiation and execution of transactions, consulting with subject matter experts as needed, including agreements related to clinical innovation initiatives. Assist with the development and implementation of digital and data initiatives and provide transactional support for supported clinical trials globally, such as mobile applications, use of social media for subject recruitment, electronic informed consent (eConsent), and integration of electronic medical records and clinical trial records (eSource). Communicate regularly with Clinical Development Legal and other attorneys (including country/regional, privacy, and regulatory counsel) to ensure consistent legal support on relevant issues across the portfolio worldwide. Advise clinical study teams overseeing trials with digital tools in specific countries/regions. Develop and support implementation of relevant policy and guideline updates. Lead efforts to understand regulatory frameworks and local requirements for use of eConsent and medical software that may be regulated as software medical device changes in laws impacting clinical trials globally. Implement updates to various agreement templates, related guidance and other instructional documents, as needed. Provide subject matter expertise, and legal support and guidance on the development and application of standard operating procedures (SOPs) and related supporting procedural documents. Provide ad hoc legal support on special projects as needed. Excellent academic credentials including a qualifying law degree is essential. Must be admitted to practice law and member in good standing in the relevant jurisdiction. Must have 10+ years legal experience in the pharmaceutical or biotech industry, with substantial transactional experience, grounding in clinical development legal issues preferably including advice re Good Clinical Practice (GCP) and FDA/other biopharma regulatory compliance.

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