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Corporate/Counsel/In House/Marlborough, Massachusetts

Company Name:
BITSOFT INTERNATIONAL, INC.
Counsel II
Duties: Will support the clinical group, with a particular focus on clinical trials, clinical trial audit and monitoring, and clinical quality matters. Supports global regulatory and quality emphasizing projects that address new product requirements under new or modified regulations. Drafts, reviews and negotiates agreements for clinical studies including consulting agreement, services agreements and pre and post-marketing study agreements with investigators, hospitals/sites, government facilities, and academic medical centers. Partners with Clinical Research Organizations and Academic Research Organizations managing studies on company's behalf. Trains and supports Clinical Sciences on legal issues, process and policy. Provides general advice on global clinical study related legal issues. Support both company-initiated and regulatory body (e.g. FDA) initiated audits of clinical trial sites and regulatory body audits of Boston Scientific clinical trials. Assists in the formation of a clinical trial, which includes input into informed consents, protocols, management of data privacy matters, selection of centers, and other aspects of trail development when needed. Keep current on legislative issues, statutes, decisions, and regulations of the FDA, EU, and other regulatory bodies with respect to clinical matters.

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