Job Details

Food & Drug Administration Attorney / Health Care Attorney in Rockville, MD

Organization Type

In-House

Job Type

Attorney

Posted on

Oct 17, 2020

Years of Experience

Min 10 yrs required

Location

Rockville, MD, United States
Practice Area
Food & Drug Administration >> Food & Drug Administration
Health Care >> Health Care
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Associate General Counsel
Duties: Provides effective legal support for matters regarding the research, development and commercialization of products and product candidates and ensure that current decisions are not in conflict with long-term goals. Provides advice, guidance and counsel to the commercial and related functions, as well as to the General Counsel, on commercial and product strategies, programs, policies, practices and initiatives in compliance with all healthcare laws, guidance documents or opinions, and industry codes. Provides legal feedback and direction on scientific, corporate or other materials proposed for publication or other external disclosure. Assists with the oversight or development of review processes for a variety of potential business activities, including but not limited to, promotional review committees or similar. Reviews and provides legal guidance concerning, and trains employees on interactions with, health care professionals, patients and others who may be in a position to influence health care decisions (e.g., payers, advocacy groups, distributors, etc.) to ensure compliance with applicable laws and regulations and standards. Supports and advises the General Counsel on the design, execution and maintenance of a robust compliance program, including compliance policies and procedures, and risk assessments. Collaborates with all departments to develop plans to improve compliance and governance infrastructure. Defines risks and clearly communicates and explains those risks to appropriate internal decision-makers for discussion and resolution. Coordinates with senior leadership for each operational group with respect to legal support to meet corporate priorities. Interacts with various internal clients and functional groups to effectively address legal and business questions and provide guidance as well as practical solutions. Supports administrative law activities as needed, such as reviews of government agency actions or requests for agency interpretation of regulatory enforcement issues. Advises on privacy and related legal regimes, such as HIPAA, data privacy and security issues and on complex business issues, compliance matters or risk assessments Leads legal department oversight on contracting efforts, including contract management process, clinical trial contracting, and others. Drafts, reviews, revises and negotiates a variety of agreements for the Company and advises on interpretation of existing agreements. Reviews and assists with the preparation of responses to communications from regulatory authorities. Provides counsel and support when necessary to any internal investigations, contract disputes, or other legal matters. Supports any litigation that arises. Provides additional support to the General Counsel on other matters and assume other responsibilities, as assigned, including the preparation and review of regular or recurring securities filings.

Qualification and Experience

Qualifications: JD Degree from an ABA-accredited law school. License to practice as an attorney in at least one US jurisdiction. 10+ years of relevant experience. Experience working in the legal department of a commercial-stage pharma/biotech company. Experience providing legal counsel on new product commercialization activities. Significant knowledge and expertise of either FDA or health care compliance considerations relevant to the biopharmaceutical industry. In-house experience providing risk assessments and legal counsel regarding financial interactions with health care professionals, scientific or product communications with health care professionals or payors, and healthcare compliance. Must be able to manage conflicting priorities in fast-paced environment, and work independently on a wide range of issues and projects, while delivering high-quality work under a tight timeline. Familiarity with corporate compliance programs; comprehensive understanding of legal terms, and excellent negotiation skills . Proven ability to develop and implement legal strategies that support business and financial objectives. Strong attention to detail. Excellent communication skills (verbal and written). Ability to apply legal concepts and practical judgment to dynamic business needs. Strong interpersonal skills with ability to effectively communicate with all levels of personnel. High energy level and high degree of self-motivation, with a sense of urgency to achieve stated business goals. Demonstrate ability to think creatively and devise solutions to challenging problems. Ability to mentor legal staff in areas of expertise. Sound judgment and commitment to ethical conduct. Strong knowledge and understanding of all healthcare laws, guidance documents or opinions, and industry codes relating to the discovery, development and commercialization of biopharmaceutical products, including but not limited to FDCA, FDA guidance Documents, Fraud and Abuse laws, Anti-kickback Statute, federal and state transparency laws, and OIG Advisory Opinions, etc. Preferred: A combination of both in-house experience in a biotechnology company and law firm practice. Degree in a scientific discipline.

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