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Food & Drug Administration Attorney / Litigation - General Attorney in Plainsboro, NJ

Novo Nordisk A/S. Mar 28,2019 Dec 26,2018 Location Plainsboro NJ
This job is expired...

In-House

Attorney

Litigation - General (consumer)

Litigation - Regulatory Enforcement (SEC, Telecom, Energy, etc.)

Min 8 yrs required

Profile

Counsel - Clinical Medical and Regulatory The candidate is responsible to provide legal support to Clinical Trial Management team, CMR Operations (including functions such as Product Safety, Medical Education, Med Info, and Quality), and Regulatory Affairs. Draft, review and negotiate contracts, particularly clinical trial agreements and service agreements. Oversee clinical trial contract review process, including substantial oversight of individuals involved in contract review process (e.g., paralegals, Global Service Center resources). Assist with the development or revision of policies and relevant training as needed. Keep abreast of regulatory developments affecting Company and generate legal strategies to resolve issues. Anticipate potential obstacles in obtaining desired regulatory outcomes and work with key stakeholders to generate and implement response strategies. Assist Quality organization and Regulatory Affairs in handling for audits and inspections by regulatory authorities, responding to Food and Drug Administration (FDA) Form 483s and warning letters, developing remediation work plans, and conducting market withdrawal/recall/field action analyses. Advise on compliance with post-market regulations, including adverse event reporting and pharmacovigilance, recalls, and good manufacturing practices. Draft comments on proposed laws and regulations, FDA guidance documents, and industry group policy positions impacting clinical development.

Qualification and Experience

The candidate must have a Bachelor's degree, JD degree and state bar admission. Minimum of 8 years legal experience is needed. Some government agency and in-house experience is preferred. Experience advising on laws, regulations, and industry standards impacting the life sciences industry is required. Comprehensive knowledge and understanding of legal concepts, principles, and practices is needed. Must display expertise in FDA regulatory law including: Good Clinical Practices (GCP); Good Manufacturing Practices (GMP); Good Pharmacovigilance Practices (GVP); PhRMA/BIO codes; Risk Evaluation and Mitigation Strategy (REMS) requirements. A deep understanding of the pharmaceutical and biotechnology industry and business model is required. Strong communication and time management skills, the ability to handle multiple projects simultaneously, and effective collaboration with other functional support groups and line of business is necessary. Strong ability to collaborate, work independently, and utilize problem- solving skills, creativity, and initiative. Strong commitment to ethical standards is necessary.

Additional info

Requisition ID: 59101BR

Company info