Compliance Director, Pharmaceuticals

Chicago area, IL

Description

Pharmaceutical company seeks Compliance Director. The successful candidate will have a strong knoweledge of PhRMA Code, FDA, and OIG standards governing the sales and marketing of pharmaceuticals.  Only candidates with pharmaceutical or medical device compliance experience (in-house, law firm, consulting firm and/or government agency) will be considered.

PRIMARY JOB FUNCTION:

• Provides direct oversight for complex elements of the company’s compliance program at the franchise, business unit, regional, divisional or corporate level.
• Responsible for directing the development and administration of Office of Ethics and Compliance education and training, and development and implementation of divisional monitoring plan, identifying compliance risk areas and communicates such risk areas to division management along with action plans to address risk.

CORE JOB RESPONSIBILITIES: Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

• The Director performs the following with minimal supervision from Ethics and Compliance Officer. – Provide leadership, guidance and support to all levels of key divisional business functions on complex ethics and compliance issues, including policy interpretation and requirement, compliance risk assessment, trend analysis and best practice recommendations. Resolves complex ethics and compliance matters that have significant impact to the company.
• Directs and conducts periodic reviews and updates related to complex Office of Ethics and Compliance policy and divisional/affiliate procedures ensuring clarity, applicability and compliance to OEC policy and external requirements with minimal supervision from Ethics and Compliance Officer.
• Develops, updates, implements, and delivers Office of Ethics and Compliance’s comprehensive training program on complex Office of Ethics and Compliance and divisional/affiliate policies and procedures.
• Provides oversight to corporate and/or divisional monitoring process to ensure compliance with OEC/affiliate policies and procedures. Reviews industry trends and internal results, and recommends corrective actions.
• Partners with Ethics Compliance Officer and business on compliance audits, oversees the fulfillment of auditors requests, acts as liaison between business and auditors during on site activities, evaluates and responds to all complex preliminary findings and recommendations, guides the business in preparing corrective action to address complex and highly complex findings and recommendations.
• Oversees all Compliance Review Committees at the divisional or affiliate level and provides input on violation process. Reviews internal trends and implement corrective actions.
• Provides leadership and guidance on proposed commercial programs, identifies complex legal and regulatory issues, analyzes alternatives and works with legal, as appropriate, to propose solutions to the business.
• Possesses in-depth knowledge of the company’s businesses supported and knowledge of the broader business impact.
• Leads cross-functional teams on complex issues or projects.

POSITION ACCOUNTABILITY / SCOPE

Accountable to Ethics and Compliance Officer and senior divisional management.

• Assigned matters/business units have significant impact to the company’s compliance program.
• Operates with autonomy and limited supervision.
• Provides guidance and direction to Coordinators, Compliance Analysts, Compliance Managers as needed.

Requirements

Minimum of 8 years experience with, or exposure to, business functions such as compliance, legal, regulatory affairs, government affairs, and finance.

BA/BS required. CPA, Masters, JD, or equivalent work experience strongly preferred.

Associate General Counsel – FDA

Boston area, MA

Description

Pharmaceutical company seeks Associate General Counsel, FDA focusing on research and development activities. The successful candidate for this position will be someone with significant, specialized experience with global regulatory requirements in the bio/pharma industry and a strong team orientation. This attorney will work with other attorneys in the company’s Legal Department on matters relating to regulatory requirements for investigational and approved products, regulatory submissions, clinical trials, drug safety management, labeling and label modification, as well as R&D and clinical compliance regulations. The successful candidate will have direct client responsibility in support of a broad range of company R&D related activity and may also serve as a dedicated lawyer for one or more of the company’s late stage development programs. Position reports directly to the VP, Chief R&D Counsel.

Specific responsibilities may include:

• Review and advise on key global regulatory filings (sBLA/BLA) and briefing documents

• Work with cross functional pre-launch team to develop product target profile and target labeling; anticipate and advise on label and approval challenges.

• Provide regulatory environment (US and ROW) updates on key activities at FDA, EMA and other global agencies that may affect our product approvals and marketed products.

• Advise Drug Safety on recent developments in risk management

• Proactively identify and manage risk profile of products in development to be best prepared to prevent and address clinical trial and post marketing products liability claims.

• Work with Drug Safety to ensure compliance with safety reporting, risk management and other post marketing safety commitments.

Requirements

• JD
• 10+ years experience with global regulatory requirements in the biotechnology or pharmaceutical industry required.

• Experience with regulatory submissions, requirements and drug safety management is required.

• Experience with government affairs, FDA and EMA regulations are required.

• Must have excellent interpersonal, decision making and communication skills.

Legal Counsel, Technology Company

Philadelphia Suburbs

Description

Technology company seeks Legal Counsel. The role involves providing legal services in support of the company’s global operations functions. The role covers a wide variety of commercial matters, including IT, and outsourcing. The successful candidate must provide practical, commercial solution-driven advice and would need to have a strong commercial background with broad-ranging technology experience. The candidate should be enthusiastic and proactive and be able to work with minimal supervision. The candidate should be comfortable supporting senior executives and working on projects with cross-functional business teams.

The role involves a wide variety of work, including:

• Drafting and advising on a variety of technology contracts, such as software as a service agreements, software development agreements, IT services agreements and software licences (both fee bearing and open source).

• Drafting and advising on business process outsourcing contracts, including data processing activities, call centres, etc.

• Drafting and advising on a variety of commercial agreements, such as supply/purchase contracts, services agreements and non-disclosure agreements.

• Drafting and advising on a variety of data contracts, such as hosting agreements and data processing agreements.

Requirements

The successful candidate must complement the small, dedicated, collaborative and passionate, existing in-house team.

A good team spirit and a practical and commercial approach to problem solving are essential.

The successful candidate must:

• be legally qualified;
• have solid general commercial and technology law experience at the 5-7 year level obtained at a major firm and/or in-house law department;
• have excellent communication skills;
• demonstrate a strong analytical mind, an aptitude for problem solving and excellent drafting skills;
• be proactive at developing internal business relationships;
• be a confident team player with an encompassing attitude to the the entire Group Legal & Secretariat Team globally;
• exercise commercial and pragmatic judgment in the advice given and solutions provided;
• be motivated, enthusiastic and have a “can do” attitude; and
• demonstrate attention to detail.

Behavioural Competencies

• Communication
• Continuous Improvement
• Customer Focus
• Deliver Results
• Information Technology
• Interpersonal Skills
• Planning & Organising
• Problem Solving
• Self-Management
• Teamwork

Senior Counsel, Research

Wisconsin

Description

Medical device company seeks Senior Counsel, Research. The Senior Counsel, Research is primarily responsible for structuring and negotiating research arrangements with key research sites and participating in the company research review processes. These research arrangements may include a wide range of the company’s medical device equipment and software. His/her tasks would also include structuring contracts with research consortia and advising on related funding arrangements.

Essential Responsibilities

• Working with the research, technology/engineering, product P&L, and intellectual property teams as a business partner to review and formalize research opportunities, and to resolve legal issues that arise in ongoing research arrangements in order to drive business product development forward

• Drafting, reviewing, negotiating, and assisting in managing strategic research agreements

• Advising the business on Good Clinical Practices (GCP), Fraud and Abuse, Regulatory, Privacy, Advertising/Promotional matters and other legal issues that arise in the research context

• Participating in the company research approval processes

• Providing regulatory and compliance advice in conjunction with the Regulatory, Finance, and Compliance specialist areas in the company

• Develop and deliver research training and associated resource materials as needed

• Consult with Medical Affairs and Clinical Affairs on adverse event evaluation and reporting

• Managing outside counsel when brought in to assist

• Applying combined business and legal judgment to proposed research arrangements, ongoing research relationships and other issues requiring legal or compliance attention

Quality Specific Goals:

• Aware of and comply with the company Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position

• Complete all planned Quality & Compliance training within the defined deadlines

• Identify and report any quality or compliance concerns and take immediate corrective action as required

Requirements

• JD (or equivalent) with active bar membership

• 8 years of legal work experience, with at least 4 years of health care experience at a large law firm, corporate legal department, government agency, or research organization, including previous experience drafting and negotiating research agreements

• Well-versed in GCP principles and research regulations with some experience with enforcing research compliance

• Previous relevant experience with IP issues as related to research projects

• Experience in, or advising the Healthcare industry, and previous exposure to medical industry regulations (FDA, Medicare/Medicaid Anti-Kickback, Privacy)

• Previous experience in identifying and resolving legal issues quickly and effectively and ability to make challenging risk decisions

• Previous experience prioritizing conflicting demands from multiple business clients in an extremely fast paced environment

Desired Characteristics

• Experience working on global research projects

• Experience working with contract research organizations

• Demonstrated experience providing legal advice in a highly regulated environment

• Experience or familiarity working with academic research centers

Patent Attorney, Electrical, Computer Science, Physics or Math

Boulder, Colorado

Description

Company seeks Patent Attorney. The attorney will be an integral part of business teams for the company. Provide dynamic support in all aspects of intellectual property including patent and trademark preparation, product clearances, agreement drafting and negotiation, and litigation. Responsibilities include:

• Ensuring that the company has the right to make and sell newly developed products

• Working with research and development to secure invention disclosures and closely follow product development projects for preparation of patent applications in assigned areas of responsibility. -Preparing and prosecuting patent applications before the USPTO and abroad.

• Supervising outside counsel in the preparation and prosecution of patent and trademark applications.

• Drafting and negotiating intellectual property agreements concerning assigned areas of responsibility.

• Managing and supporting outside counsel concerning potential litigation matters.

• Addressing intellectual property aspects of acquisitions and divestitures.

Requirements

• J.D. plus admission to a state bar and the USPTO

• 4-8+ years patent law practice experience

• Prefer a Bachelor of Science in electrical engineering, physics, mathematics and/or computer science, but candidates without that specific academic technology background will be considered if they have significant electrical or computer science patent law experience.

• strong business acumen

Regulatory Counsel (Sales & Marketing), Medical Devices

Southern California

Description

Medical device company seeks Regulatory Counsel to support sales and marketing activities.  Position will be the primary attorney handling these matters in the legal department.

Duties:

• Facilitate the business objectives of the company by providing practical, timely and effective legal support, while minimizing potential legal risks

• Provide high quality guidance and support to the company’s regulatory and quality assurance teams and business units on healthcare and medical device regulatory matters

• FDA regulatory matters

• Advertising and promotion

• Healthcare fraud and abuse

• Antitrust (such as tying arranagements)

• Anti-corruption

• Implement policies and procedures

• Coordinate cross functional, regional teams

• Oversee compliance monitoring (in partnership with the Compliance Department)

• Assess risks and establish metrics for effectiveness

• Work in close cooperation with Compliance Department, including participation in investigations when required

• Develop a thorough understanding of and familiarity with: the company’s business, its people, products, markets, facilities, customers and competitors and use this knowledge in providing guidance and counsel

• Identify training needs and assist in development and presentation of training and education regarding regulatory requirements and developments

• Perform special assignments or projects if necessary

Requirements

Required:

• 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 US device marketing, advertising and promotion regulations

• Ability to analyze and interpret efficacy and safety data

• Decision-making ability and experience

• Problem solver—able to find practical solutions and provide practical guidance

• Accountable and hands-on, self-starter, results oriented

• Desire to understand products and business

• Able to gain the trust of and form solid relationships with various business clients and Legal Department colleagues

• Able 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 Compliance, Medical Device

Minneapolis

Description

Medical device company seeks Director Compliance to head up compliance at one of  its subsidiary sites. The Director will have direct responsibility for the operational excellence and enhancement of the subsidiary compliance program.  The Director will serve as an integral member of the Corporate Compliance Leadership Team and will be expected to influence the strategic direction of the company’s Corporate Compliance Program.

Requirements

To qualify for this role, you will possess:

• Bachelor’s degree required and Law degree preferred (but not required).

• At least 8 years of medical device or pharmaceutical company compliance program experience as either a member of a corporate compliance team, consultant, or outside counsel.

• Must have experience leading a team of employees and interacting with all levels of employees.

• Proven record of accomplishment in the areas of compliance policies, training, auditing, monitoring and investigations.

• Strong working knowledge of various laws, regulations, and industry guidance that affect the corporate-wide compliance program, including federal and state government price reporting laws, fraud and abuse and anti-kickback statutes, OIG and PhRMA guidelines, state marketing compliance laws, and anti-bribery laws.

• Effective public speaking skills and an ability to communicate in both verbal and written form with employees throughout the company.

• Must possess excellent organizational and planning skills and the capacity to simultaneously handle a variety of complex confidential issues.