The Association of Corporate Counsel (ACC) is the world's largest organization serving the professional and business interests of attorneys who practice in the legal departments of corporations, associations, nonprofits and other private-sector organizations around the globe.
Compliance, General Commercial/Contracts, Pharmaceuticals
Senior-level (Director or Senior Director) Life Sciences Regulatory Attorney based in Dallas, Denver or Teaneck. Responsible for providing regulatory legal advice to Cognizant Life Sciences business on global regulatory requirements pertinent to the company's services and software products.
Strong regulatory background on R&D/pharma/Contract Research Organization (CRO) requirements; Experience advising a CRO or technical service provider a plus.
Knowledge and experience providing advice to companies regarding application and compliance with global laws and regulations (US, EU, APAC) such as ICH Good Practices (GMP, GCP, GVP), MHRA, 21 CFR Part 11/Annex 11 (EU), and medical device regulations and related guidance.
Ability to work independently at a senior level with business stakeholders.
Understanding of IEEE GAMP guidance for development of systems and software for the pharmaceutical, biologic, and medical device industries.
Familiarity with HIPAA privacy and security regulations and GDPR as applied to life sciences and clinical research data collected at clinical sites globally.
Proven experience creating and implementing legal strategies and tactics; legal risk management; and standardized contract language for contractors of pharmaceutical, biologics and/or medical device companies; Intellectual property experience a plus.
Knowledge and experience developing and reviewing contracts, SOWs and other agreements to flag and address key regulatory compliance requirements.
Advanced communication skills (verbal, written, listening, negotiating) including ability to communicate professionally with regulators, executives, clients and operations staff at all levels in a fast-paced environment.
Experience managing multiple direct and indirect reports.
A minimum ten years of experience providing legal advice within the life sciences industry.
JD from accredited law school and active bar licensure in at least one state.
Negotiate regulatory terms in service agreements for some or all of life science services (BPO, BPaaS, PaaS, SaaS delivery models), life science’s products and platforms, lines of business and other tools used in support of regulated activities.
Provide legal advice to business clients and commercial attorneys on regulatory requirements related to products and services provided to life science clients.
Assist in the development of new products and services by identifying applicable regulatory requirements.
Support corporate compliance in the development and implementation of policies and procedures, oversight, internal advisory/consulting and monitoring/reporting activities to ensure compliance with all applicable global regulations.
Work with internal business and product teams to determine any applicable licenses necessary to support the products and/or services provided.
Identify and mitigate regulatory risk across all life sciences lines of business.
Manage the implementation of new global laws and regulations affecting regulated activities and products.
Interpret and communicate pending and adopted legislation and regulations to the appropriate departments and groups. Review relevant life sciences legal proceedings, court judgments, and case law, and apply lessons learned.
Coordinate and collaborate with life sciences management, business delivery and development teams to ensure awareness of regulations and regulatory expectations relevant to life sciences lines of business.
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