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Food & Drug Administration Attorney in Morrisville, NC

Syneos Health Oct 21,2021 Sep 09,2021 Location Morrisville NC
This job is expired...

In-House

Attorney

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

Min 12 yrs required

Profile

Managing Counsel Duties: Key legal advisor for global commercial activities involving medicines and devices including: US FDA promotional laws, regulations, guidance documents, industry codes, other state and federal laws, regulations and guidance (e.g., HIPAA, CAN-SPAM, Sunshine/Transparency, anti-kickback, antitrust, Lanham Act) and product liability laws; drug pricing, governance, market access considerations, and patient support programs; commercial programs supporting medicines (e.g., consulting, communications, HUB services), with a strong working knowledge of relevant laws, regulations, and related OIG guidance; Provide counsel regarding the external legal environment relating to the Commercial business, with a clear understanding of industry practices. Advise regarding agreements relating to the commercial business. Lead a team within the Office of General Counsel. Collaborate with Compliance and Ethics Office personnel on regulatory compliance requirements and related operational issues, including fraud, anti-kickback, off-label promotion, anti-corruption, etc. Engaging with cross-functional teams to support strategic business initiatives and effectively communicate complex information in clear and concise terms. Manage external counsel in accordance with outside counsel guidelines.

Qualification and Experience

Qualifications: U.S. JD Degree. Current member of a state bar in good standing. 12+ years relevant experience. Experience in US FDA promotional laws/regulations. Experience with global regulations relating to the approval, purchase, promotion, and distribution of medicines and devices. Working knowledge about US pricing and reimbursement for medicines.
Other preferred characteristics: Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk. Adept at managing individual and team performance, building strong relationships, managing trusted stakeholder relationships internally and externally. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Practiced at implementing change initiatives and leading change. Able to sustain energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Committed to developing people and building a talent pipeline. Able to translate strategy into action – build a compelling narrative, motivate others, sett objectives and delegation. Sense of humor is a plus.

Additional info

Ref. 21010424

Company info