Patent Attorney, Electrical, Computer Science, Physics or Math

Compliance Director – Pharmaceutical Company The pharmaceutical company seeks a Compliance Director with a strong knowledge of the PhRMA Code, FDA, and OIG standards governing the sales and marketing of pharmaceuticals. Candidates must have pharmaceutical or medical device compliance experience (in‑house, law firm, consulting firm, and/or government agency). Responsibilities: Provide direct oversight for complex elements of the company’s compliance program at the franchise, business unit, regional, divisional or corporate level. Direct the development and administration of Office of Ethics and Compliance education and training, and develop and implement a divisional monitoring plan, identifying compliance risk areas and communicating them to division management with action plans. Lead compliance with applicable Corporate and Divisional Policies and procedures. Provide leadership, guidance and support to key divisional business functions on complex ethics and compliance issues, including policy interpretation, compliance risk assessment, trend analysis and best practice recommendations. Resolve complex ethics and compliance matters that significantly impact the company. Direct and conduct periodic reviews and updates of Office of Ethics and Compliance policy and divisional procedures to ensure clarity, applicability and compliance with external requirements. Develop, update, implement and deliver Office of Ethics and Compliance’s comprehensive training program. Provide oversight to corporate and/or divisional monitoring processes, review industry trends and internal results, and recommend corrective actions. Partner with the Ethics Compliance Officer on compliance audits, oversee fulfillment of auditors’ requests, act as liaison during onsite activities, evaluate and respond to preliminary findings, and guide the business in preparing corrective actions. Oversee all Compliance Review Committees at the divisional or affiliate level and provide input on the violation process, reviewing internal trends and implementing corrective actions. Provide leadership and guidance on proposed commercial programs, identify complex legal and regulatory issues, analyze alternatives, and collaborate with legal to propose solutions. Possess in‑depth knowledge of the company’s businesses and the broader business impact. Lead cross‑functional teams on complex issues or projects. Accountability / Scope: Accountable to Ethics and Compliance Officer and senior divisional management. Assigned matters/business units have significant impact on the company’s compliance program. Operate with autonomy and limited supervision. Provide guidance and direction to Coordinators, Compliance Analysts and Compliance Managers as needed. Requirements: Minimum of 8 years experience in compliance, legal, regulatory affairs, government affairs, or finance. BA/BS required; CPA, Masters, JD, or equivalent work experience strongly preferred. Proven leadership experience in compliance programs. Associate General Counsel – FDA (Biopharma) Pharmaceutical company seeks an Associate General Counsel focusing on FDA regulatory matters related to R&D activities. The attorney will work with the Legal Department on investigational and approved products, regulatory submissions, clinical trials, drug safety management, labeling, and R&D compliance regulations. The position reports directly to the VP, Chief R&D Counsel. Responsibilities: Review and advise on key global regulatory filings (sBLA/BLA) and briefing documents. Work with the cross‑functional pre‑launch team to develop product target profiles and labeling, anticipating and advising on label and approval challenges. Provide regulatory environment (US and ROW) updates on key activities at FDA, EMA and other global agencies affecting product approvals and marketed products. Advise Drug Safety on recent risk‑management developments. Proactively identify and manage risk profiles of products in development to prevent and address clinical trial and post‑marketing liability claims. Work with Drug Safety to ensure compliance with safety reporting, risk management and other post‑marketing commitments. Requirements: JD 10+ years experience with global regulatory requirements in biotechnology or pharmaceutical industry. Experience with regulatory submissions, requirements and drug safety management. Experience with government affairs, FDA and EMA regulations. Excellent interpersonal, decision‑making and communication skills. Legal Counsel – Technology Company Technology company seeks Legal Counsel to provide legal services for global operations, focusing on commercial matters including IT and outsourcing. The candidate must have a strong commercial background with broad technology experience and be able to support senior executives and work on cross‑functional projects. Responsibilities: Draft and advise on technology contracts (SaaS, software development, IT services, software licenses). Draft and advise on business process outsourcing contracts (data processing, call centres, etc.). Draft and advise on commercial agreements (supply/purchase contracts, services agreements, NDAs). Draft and advise on data contracts (hosting agreements, data processing agreements). Requirements: Legally qualified. 5–7 years of general commercial and technology law experience at a major firm and/or in‑house department. Excellent communication and drafting skills. Strong analytical mind and problem‑solving aptitude. Proactive in developing internal business relationships. Team player with a global perspective. Commercial and pragmatic judgment in advice and solutions. Motivated, enthusiastic, and a “can‑do” attitude. Senior Counsel – Research (Medical Device) Medical device company seeks a Senior Counsel, Research responsible for structuring and negotiating research arrangements with key sites, participating in the research review processes, and providing legal support for research activities. Responsibilities: Partner with research, technology/engineering, product P&L, and IP teams to review and formalize research opportunities, resolving legal issues in ongoing research arrangements. Draft, review, negotiate, and manage strategic research agreements. Advise the business on GCP, fraud and abuse, regulatory, privacy, advertising/promotional matters and other legal issues arising in research. Participate in company research approval processes. Provide regulatory and compliance advice with regulatory, finance, and compliance specialists. Develop and deliver research training and associated resources. Consult with Medical Affairs and Clinical Affairs on adverse event evaluation and reporting. Manage outside counsel when required. Apply combined business and legal judgment to research arrangements and compliance matters. Requirements: JD (or equivalent) with active bar membership. 8+ years of legal experience, at least 4 years in healthcare at a large law firm, corporate legal department, government agency or research organization, including drafting and negotiating research agreements. Well‑versed in GCP principles and research regulations with some experience enforcing research compliance. Experience with IP issues related to research projects. Experience in the healthcare industry and exposure to medical industry regulations (FDA, Medicare/Medicaid anti‑kickback, privacy). Demonstrated ability to identify and resolve legal issues quickly and effectively. Experience prioritizing conflicting demands from multiple business clients in a fast‑paced environment. Desired Characteristics: Experience working on global research projects. Experience with contract research organizations. Demonstrated experience providing legal advice in a highly regulated environment. Experience or familiarity working with academic research centers. Patent Attorney – Technology Company Company seeks a Patent Attorney to support business teams in intellectual property matters, including patent and trademark preparation, product clearances, agreement drafting and negotiation, and litigation. Responsibilities: Ensure the company has the right to make and sell newly developed products. Work with R&D to secure invention disclosures and follow product development projects for patent application preparation. Prepare and prosecute patent applications before the USPTO and abroad. Supervise outside counsel in the preparation and prosecution of patent and trademark applications. Draft and negotiate intellectual property agreements. Manage and support outside counsel regarding potential litigation matters. Address intellectual property aspects of acquisitions and divestitures. Requirements: J.D. plus admission to a state bar and the USPTO. 4–8+ years of patent law practice experience. Prefer a Bachelor of Science in electrical engineering, physics, mathematics and/or computer science, but candidates without that specific background will be considered if they have significant electrical or computer science patent law experience. Strong business acumen. Regulatory Counsel – Sales & Marketing (Medical Device) Medical device company seeks Regulatory Counsel to support sales and marketing activities and serve as the primary attorney for regulatory and quality assurance teams. Duties: Provide practical, timely, and effective legal support to minimize potential legal risks. Offer high‑quality guidance to regulatory and quality assurance teams and business units on healthcare and medical device regulatory matters. Handle FDA regulatory matters, advertising and promotion, healthcare fraud and abuse, antitrust, and anti‑corruption. Implement policies and procedures. Coordinate cross‑functional, regional teams. Oversee compliance monitoring with the Compliance Department. Assess risks and establish metrics for effectiveness. Participate in investigations when required. Develop a thorough understanding of the company’s business, products, markets, facilities, customers, and competitors. Identify training needs and assist in development and presentation of training and education regarding regulatory requirements. Perform special assignments or projects if necessary. Requirements: JD. Licensed and admitted to practice law in good standing in at least one U.S. state. At least 7 years of experience in private practice, in‑house counsel and/or government (FDA). Demonstrated experience in FDA regulatory law. Experience with U.S. device marketing, advertising and promotion regulations. Ability to analyze and interpret efficacy and safety data. Decision‑making ability and experience. Problem‑solving: able to find practical solutions and provide guidance. Accountable, hands‑on, self‑starter, results‑oriented. Desire to understand products and business. Ability to build trust and solid relationships with business clients and Legal Department colleagues. Ability to manage multiple high‑priority projects simultaneously. Desired Experience: At least 2–3 years as in‑house counsel in medical device or pharmaceutical industry. General understanding of medical device regulation outside of the U.S. Director of Compliance – Medical Device Medical device company seeks a Director of Compliance to head compliance at one of its subsidiary sites, responsible for operational excellence and enhancement of the subsidiary compliance program. The Director will be an integral member of the Corporate Compliance Leadership Team. Key Responsibilities: Develop and implement annual and long‑term strategic compliance plans in collaboration with Compliance Operations, reflecting the seven elements of an effective compliance program for the subsidiary businesses. Ensure all compliance program policies, procedures, training, auditing and monitoring are in place, and support investigations of any allegations of non‑compliance related to these businesses. Implement and enhance international compliance initiatives. Provide compliance status reports to business partners, the Corporate Compliance Leadership Team and the EVP, Corporate Compliance & Business Practices. Advise clients on compliance with applicable policies and procedures. Maintain current knowledge of laws, regulations, and industry guidance affecting the corporate‑wide compliance program (federal and state government price reporting laws, fraud and abuse, anti‑kickback statutes, OIG, AdvaMed and PhRMA guidelines, state marketing compliance laws, anti‑bribery laws). Collaborate across the Corporate Compliance & Business Practices Department to ensure effective and sustainable enterprise‑wide compliance programs. Lead a team of two Corporate Compliance professionals. Requirements: Bachelor’s degree required; Law degree preferred. At least 8 years of medical device or pharmaceutical company compliance program experience (corporate compliance team, consultant, or outside counsel). Experience leading a team of employees and interacting with all levels of employees. Proven record in compliance policies, training, auditing, monitoring and investigations. Strong knowledge of laws, regulations, and industry guidance affecting corporate‑wide compliance programs. Effective public speaking skills and ability to communicate verbally and in writing with employees throughout the company. Excellent organizational and planning skills with capacity to handle complex confidential issues. Location: Minneapolis, MN #J-18808-Ljbffr Edge Consulting