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General Counsel
Consulting
provided
exceptional
service in helping
my organization
recruit for a hard
to fill position.
They did extensive
work on the front
end to understand
our needs and
our culture and
began referring
highly qualified
candidates almost
immediately.

Melinda Burrows
Deputy General Counsel
- Litigation and
Compliance, Progress
Energy Service Company
LLC

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Counsel Jobs > Senior Counsel, Healthcare Law and Compliance Job in Massachusetts > Senior Counsel, Healthcare Law and Compliance

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YOUR WINDOW TO A WORLD OF OPPORTUNITIES

Senior Counsel, Healthcare Law and Compliance

Refer job# VNWO139763

Senior Counsel, Healthcare Law and Compliance The candidate will be playing a lead role in providing legal advice on regulatory issues, including FDA regulatory matters and compliance with laws, regulations, industry standards and company policies that arise throughout the pharmaceutical product life cycle. Will counsel and provide legal service to a wide range of internal clients, including firm clinical operations, regulatory, operations and manufacturing teams on matters arising from federal, state and local regimes, as well as regulatory matters under counterpart regimes in other countries. Work closely with the C-suite executive team, business leadership, the legal, finance, and clinical operations departments, and outside counsel, to further the Company s ambitious agenda. Leveraging prior pharmaceutical/biotech industry experience along with public company and/or large law firm experience. Manage outside counsel to meet expectations of internal team. Establish healthcare compliance program, including policies and training materials, spanning patient community activities and medical affairs interactions. Interact with pharmacovigilance group and act as primary counsel for early stage research activities. Act as Chief Privacy Officer responsible for compliance with US and EU privacy requirements; develop privacy breach response plan in conjunction with IT Group. Work with communications department to ensure consistency and accuracy in outward communications and public interactions. Assist with management of commercial agreements including partnership, manufacturing, quality and raw material purchase. Provide legal advice and support in a wide array of practice areas and special projects as needed. The candidate must have 7-10 years experience with heavy focus on public company biotech or pharmaceutical regulatory and compliance function. Should have 3 years in the healthcare practice of a strong law firm. A combination of both law firm and in-house public company experience is ideal. Bachelor s degree plus JD from an accredited law school; active membership in at least one state Bar is needed. A thorough understanding of healthcare laws, including the Food, Drug and Cosmetic Act, and laws related to development and commercialization of pharmaceutical products (including healthcare fraud and abuse laws) is must. Experience advising on complex regulatory issues relating to novel biologics is must. An understanding of the explicit procedures and requirements of regulatory regimes as well as practical approaches for navigating agency dynamics and informal channels is required.

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