About Us: Gore is a materials science company focused on improving lives through discovery, product innovation and rewarding careers for our Associates. Learn More.
About the Industry: Saving lives and improving the quality of life for patients is at the core of everything we do. This meaningful work gives purpose to our lives and inspires us to create solutions that make a difference in the lives of others. Learn More.
About the Role: W.L. Gore is seeking an attorney to join our Global Legal Team in Flagstaff, Arizona. In this role, you will provide life sciences-based legal advice and regulatory support for the Gore medical device and pharm-bio businesses. Your practice will include Food & Drug Administration (FDA) regulation of the research, manufacture, approval / clearance, promotion, sales and stewardship of medical devices and technical products used in the development, processing, and packaging of pharmaceuticals and biologicals. This position requires knowledge of the laws and regulations applicable to clinical research, product development, product approval, manufacturing (QMS and cGMP), advertising and promotion (including social media), anti-kickback statutes, false claims, reimbursement and payers, data privacy and HIPAA. This senior counsel-level position will collaborate closely with other members of the Legal, Regulatory Affairs, Compliance, Clinical, Office of Medical Affairs, Marketing, and Quality teams.
Responsibilities: * Providing practical advice to allow Gore to meet its objectives through interpreting and applying the laws and regulations applicable to its life sciences businesses
* Responding to routine regulatory inquiries, new product submissions, inspections and audits by government agencies (including experience with FDA and MDSAP)
* Providing transactional advice and drafting related language for contracts that involve life sciences topics (research, product development, procurement, third party manufacturing, etc.)
* Identifying and coordinating legal advice for related life sciences issues, such as data privacy, ethics and compliance, product liability and litigation, anti-bribery and corruption, intellectual property and anti-trust law
* Partnering closely with other legal team members to provide efficient and integrated legal advice to business and functional clients
* Coordinating legal advice for matters with regional or global implications
* Developing and delivering internal training on legal and regulatory topics
* Providing advice and reviewing marketing and promotional activities
* Monitoring compliance with current life sciences related Enterprise policies and procedures
* Assisting with or leading investigations and resolving reports of alleged regulatory or life sciences related non-compliance; developing and implementing appropriate corrective action plans
* Monitoring and evaluating regulatory developments from government agencies and advisory bodies and industry trends to determine needed changes and to develop proactive approaches to emerging industry issues
Required Qualifications: * Juris Doctorate degree from an accredited university, admitted to practice in good standing in at least one U.S. state
* Minimum 6 years of relevant legal or regulatory work experience in advising clients in a regulated life sciences business
* Demonstrated knowledge of FDA laws and regulations, standards and guidance applicable to medical devices or other life sciences products; helpful to have experience with similar agencies and requirements in other jurisdictions (EMEA, Japan, South America)
* Preference for experience with value-based healthcare, risk-sharing arrangements, digital health and market access as related to reimbursement and payer matters
* Prior in-house experience preferred
* Excellent writing, communication, and organizational skills
* Strong business acumen, and understanding of strategic and tactical business issues
* Ability to work and problem-solve independently, as well as collaboratively, as part of a team in a matrixed organization
* Ability to travel up to 30%, including international destinations
Desired Qualifications: * Ability to:* Work with multiple functional areas, cultures and nationalities * And flexibility to prioritize and handle multiple tasks/projects
What We Offer: At Gore, we offer comprehensive, competitive rewards in the form of compensation and benefits. Among these are work-life balance and sports programs, 401(k) Plan with a gift, Associate Stock Ownership Plan, Health & Well-being program with full health plan, and a flexible working program. Within Gore, you will find a unique culture, diversity, equity, and inclusion initiatives, and opportunities for growth and development.
Learn more about: benefits, diversity, and growth & development.
We believe in the strength of a diverse workforce and inclusive work environment. In support of our values and continued success we are proud of Associates around the world who support an inclusive work environment, strive to reflect the diversity of the communities where we operate, and ensure all Associates and external partners are treated with fairness, dignity, and respect.
Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening.
Gore requires all applicants to be eligible to work within the U.S. Gore generally will not sponsor visas unless otherwise noted on the position description.
Gore is a M/F, Disabled and Vet EEO/AA employer. (Applies to all positions in the U.S.)
gore.com/change-life Our Talent Acquisition Team will be pleased to answer your questions via contact us.
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