Corporate Counsel - Global Clinical Operations - Pharma

Profile

Corporate Counsel - Global Clinical Operations - Pharma

The candidate will provide substantive legal advice on all laws, regulations and rules regarding the conduct of clinical studies of pharmaceutical product candidates and products, including laws and regulations promulgated by the Food & Drug Administration (FDA). Manage legal risks relating to key topics in the clinical area, including payments to clinical sites and investigators, patient recruitment and advertising, payments/reimbursement to patients, anti-kickback and anti-corruption compliance generally, patient injury and reimbursement, product liability issues, and data integrity. Provide legal support with respect to pharmacovigilance and safety reporting. Provide substantive legal advice with respect to regulatory inspections, inspection readiness, and responses to regulatory authorities (e.g., FDA, EMEA) in connection with Shionogi development programs, New Drug Applications (NDAs), or Marketing Authorization Applications abroad. Lead the Data Privacy Program for the company to ensure compliance with global regulations regarding data privacy. Coordinate with Shionogi affiliates regarding Data Privacy across different geographic regions. Provide contract drafting and agreement review relating to clinical trials, including Service agreements with global Clinical Research Organizations (CROs), Agreements with service providers and vendors in support of R&D activities, such as central laboratory services, statistical analysis, data management, regulatory support, special software applications and Advisory Committee preparation, Agreements with clinical investigators and individual study sites, including academic sites, Clinical disclosure related documents such as patient Informed Consent Forms, IRB approvals, clinical trial advertising ensuring that recruitment initiatives are compliant with applicable laws and regulations, Agreements relating to the conduct of observational studies and data aggregation studies for the purpose of generating real word evidence (RWE) regarding how pharmaceutical products are used by the medical community. Ancillary documentation such as letters of indemnification, letters of representation, and documentation relating to safety monitoring boards. Work closely with Shionogi Headquarters and its affiliates to ensure global standards for clinical contracts are established and observed in a coordinated and consistent fashion. Provide contract review and support for other types of contracts encountered in the pharmaceutical business. Participate as an engaged member of the Legal Group to handle other legal issues as they may arise.

Additional Information

Requisition Number: REQCL001548.

Company info

Shionogi Inc.
100 Campus Drive
Florham Park
New Jersey
United States 07932
Website : https://www.shionogi.com/