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Food And Drug Administration Attorney Jobs in In-House

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Company
In-House
Experience
Min 5 yrs required
Location
Redwood City, CA
Posted Date
Feb 27, 2020
Info Source
Employer
Total Views
19
Senior Counsel RESPONSIBILITIES: Maintain a current working knowledge of the various laws, regulations, and industry guidance relevant to the compliant commercialization of pharmaceutical products. This includes the Federal Anti-kickback Statute, False Claims Act, Food Drug and Cosmetics Act, the OIG and DOJ guidelines, PhRMA Code, US state and local marketing compliance laws and recent government enforcement actions. Utilize knowledge to advise on and assist in the review... read more
Company
In-House, Alexion Pharmaceuticals, Inc.
Experience
Min 12 yrs required
Location
Boston, MA
Posted Date
Feb 26, 2020
Info Source
Employer
Total Views
47
Director, US Market Access and Patient Services Compliance Business Partner Duties: Independently drives the development, implementation and management of the compliance program, including policy, process, training, communication, programs and systems for the Market Access and Patient Services teams. Serves as a Compliance subject matter expert and partners with Market Access and Patient Services leadership to set the strategic tone and align tactical direction for the o... read more
Company
In-House
Experience
Min 8 yrs required
Location
North Chicago, IL
Posted Date
Feb 26, 2020
Info Source
Employer
Total Views
12
Senior Counsel, U.S. Market Access Duties: Responsible for compliance with applicable policies and procedures. Develop in-depth knowledge of business, company imperatives, and keep abreast of changes in laws that affect client areas. Provide clear advice to business clients and senior legal management on U.S. laws focusing on market access contracting, FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, and competition law. Responsible for preparing, re... read more
Company
In-House
Experience
Min 10 yrs required
Location
Mountain View, CA
Posted Date
Feb 19, 2020
Info Source
Employer
Total Views
3
Senior Counsel, Head of Compliance The candidate will be responsible for the design, implementation and continual improvement of the Compliance Program to support the vision, values and corporate goals of the company. Will partner with functions such as Commercial, Medical Affairs, Research & Development, Regulatory Affairs and Human Resources to understand their business priorities, and provide compliance support on the strategy and tactics to achieve their objectives. Wi... read more
Company
In-House, Fulcrum Therapeutics, Inc.
Experience
Min 12 yrs required
Location
Cambridge, MA
Posted Date
Feb 25, 2020
Info Source
Employer
Total Views
46
General Counsel Responsibilities: Develop functional plans for managing legal matters, including activities to be performed in-house or through outside counsel to best manage company’s legal activities and minimize risk for the business. Manage and advice on corporate governance, business development transaction, securities, law compliance, general transaction support, license agreements, employment law, regulatory matters, risk management, financing activities, and gene... read more
Company
In-House
Experience
Min 10 yrs required
Location
Milwaukee, WI
Posted Date
Feb 18, 2020
Info Source
Employer
Total Views
3
Chief Regulatory Counsel The candidate serves as the principal legal advisor with regard to global medical device and pharmaceutical laws and regulations. Supports the **MEMBERS ONLY**SIGN UP NOW***. Chief Quality Officer and works closely with the quality, regulatory, legal and business teams around the world to analyze quality and regulatory laws and regulations affecting **MEMBERS ONLY**SIGN UP NOW***.. Provide tactical and strategic legal advice on laws, regulations and regulatory guidance; Directly part... read more
Company
In-House, AbbVie Inc.
Experience
Min 8 yrs required
Location
North Chicago, IL
Posted Date
Feb 26, 2020
Info Source
Employer
Total Views
27
Senior Counsel, U.S. Market Access Duties: Responsible for compliance with applicable policies and procedures. Develop in-depth knowledge of business, company imperatives, and keep abreast of changes in laws that affect client areas. Provide clear advice to business clients and senior legal management on U.S. laws focusing on market access contracting, FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, and competition law. Responsible for preparing, re... read more
Company
In-House
Experience
Min 3 yrs required
Location
Somerset, NJ
Posted Date
Feb 26, 2020
Info Source
Employer
Total Views
4
Senior Counsel The candidate’s duties include: Draft, review, analyze, structure and negotiate manufacturing, packaging, pharmaceutical development, purchase, supply, license and master service agreements. Advise business unit personnel with respect to compliance policies, customer and vendor relations, contract matters, and regulatory issues. Assist in merger and acquisition activity. Assist in corporate governance activity. Provide general advice to management on a day... read more
Company
In-House, Amgen, Inc.
Experience
Min 4 yrs required
Location
Thousand Oaks, CA
Posted Date
Feb 26, 2020
Info Source
Employer
Total Views
17
Senior Counsel—Strategic Transactions Candidate will be part of a legal team that supports Business Development group in a variety of life sciences transactions, including mergers and acquisitions, divestitures, collaborations, and in-licenses and out-licenses involving biotech and pharmaceutical products and technology, while working closely with other functional groups (R&D, Finance, Operations, Commercial), and coordinating with various members of the Law Department. ... read more
Company
In-House
Experience
4-6 yrs required
Location
New York City, NY
Posted Date
Feb 22, 2020
Info Source
Employer
Total Views
38
Legal Counsel - Claims Responsibilities: Act as Principal contact person in the claims review. Perform legal and compliance review of advertising copy in all forms of media including but not limited to, television, digital media, packaging, print, public relations and other promotional materials. Reviews test reports test designs and literature to determine if sufficient for claims support. Create claims dossiers and provide substantiation dossiers to authorities in the US... read more
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