Counsel II
Location: Warrendale, Pennsylvania
Description: BAYER is employing Counsel II right now, this occupation will be settled in Pennsylvania. For detail informations about this occupation opportunity please read the description below. Bayer HealthCare (BHC) makes an important contribution to human and animal health with its innovative products and by researching new therapeutic approaches. Our Specialty Pharmaceutical business ranks among the top 10 specialty pharmaceutical companies worldwide. Our global research and development is focused in five distinct areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Specialized Therapeutics, and Women†s Healthcare. As a specialty pharmaceuticals company, we at Bayer HealthCare focus our efforts where we can have the most impact. Our Diabetes Care division is one of the largest self-test diagnostic businesses in the world, supporting customers in 100 countries. Our Consumer Care business is a top competitor in many important product categories including analgesics, cough and cold, and nutritionals. More than 3,000 employees support 14 manufacturing sites in 11 countries dedicated to ensuring the delivery of a secure, high-quality, cost-effective supply of our products around the world. Our Animal Health business in North America is dedicated to making the world a better place for our veterinary customers, their clients, and the animals we all hold dear. Bayer Radiology & Interventional Law and Patents We offer a wide variety of competitive compensation and benefit programs. In addition to a competitive base salary, you will be eligible for an array of innovative rewards and recognition programs, variable pay and incentive opportunities as well as benefits coverage beginning on your first day of employment. We are committed to helping our employees maintain a healthy balance between their responsibilities at work and home. You will be eligible for paid time off programs, paid company holidays, flexible work options and numerous site conveniences. We are also committed to supporting your professional development through career ladders, training programs, tuition assistance and professional association events.
If you meet the requirements of this unique opportunity, we encourage you to explore how you can make a difference at Bayer by applying now.
To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
- Reports to Chief Legal Officer;
- Has direct contact with all levels of employees throughout the company and Interventional Executive Committee;
- Has direct contact with all members of the law department, with corporate healthcare compliance officer and compliance specialist and with members of corporate global law department around the world;
- Has direct contact with outside counsel.
This position is will not provide VISA sponsorship The primary responsibility of this role is to provide timely and high-quality legal support and guidance, primarily to our interventional business segment, located in Coons Rapid, Minnesota and Kirkland, Washington and at the John P. Friel Center for Innovation and the Global Center in Pittsburgh, Pennsylvania.
The incumbent will:
- The position will collaborate with internal clients at all levels of management to effectively balance the goal of minimizing legal risk to the Interventional segment with the need to support and assist in the achievement of business and strategic objectives involving development and distribution of FDA (and equivalent agencies outside the US) regulated medical devices globally;
- The position must have the ability to work confidently with a high level of independence and responsibility to provide legal advice and support directly to the business clients he/she supports;
- The position handles a high volume of promotional content review for the sales and marketing functions of the Interventional business and a high volume of contract work for the sales and marketing and other functions of the business as well as provide support for certain day to day needs of the Interventional business;
- The position will also provide cross organizational support at Bayer Radiology and Interventional in select areas including contracts.
- Marketing Materials †Ensure timely, accurate, consistent review and approval of all product labeling/marketing materials with a deep understanding of the Interventional businesses products and their associated uses;
- HealthCare Professional Interactions †Find solutions to efficiently and effectively develop legally compliant relationships with healthcare professionals and government officials with an initial need for emphasis on speaker programs;
- Reimbursement/HealthCare Economics †Ability to provide legal guidance;
- Regulatory and Clinical Affairs †Provide legal counsel on FDA regulatory approval process for medical devices and to active clinical/medical affairs organization;
- General Contracts †Prepare, negotiate, review and revise all contracts, including product sales agreements, consignment agreements, rebate agreements, and capital equipment agreements with customers, finished goods and raw materials supply agreements, clinical trial, registry, research and consulting agreements, software licenses, capital equipment purchase agreements, non disclosure agreements, product design and manufacturing agreements, etc;
- Distributor Agreements †Structure and negotiate sales and marketing incentive programs with product distributors and resellers;
- GPO/National Account Transactions †Assist with bid responses and negotiate transactions with regional and national group purchasing organizations and national account customers;
- Compliance †Address the impact of constantly changing health care law issues for interventional business and implement policies and procedures to ensure compliance with government and industry initiatives and regulations (e.g., Country Codes of Ethics and legal requirements for Medical Device Manufacturers, Anti-Kickback Law, antitrust issues, anti-bribery, etc.);
- Training †Provide training to employees with respect to wide range of issues facing a healthcare products business, including development of labeling and promotional content, reimbursement, contracting best practices, antitrust issues, FDA and regulatory issues, etc;
- Strategic Opportunities †Potentially provide guidance and structure, draft and negotiate agreements with respect to various strategic opportunities, including joint-ventures, joint-development relationships, private-label transactions, out-sourcing and off shore manufacturing arrangements, etc.
- JD from an accredited US law school and admission to PA bar;
- 3 to 5 years of relevant legal experience as a corporate/commercial attorney, preferably in a midsize to large law firm setting and/or other relevant in-house experience;
- Experience drafting and negotiating sophisticated contracts;
- Extensive experience in global advertising and promotion requirements for medical devices and in reviewing labeling/promotional content;
- Experience in providing legal counsel for global medical device strategy based on relevant legal and regulatory environment, including experience with legal aspects of regulatory approval process for medical devices and in counseling active clinical/medical affairs organization with high volume international clinical research activities;
- Ability to provide legal guidance on safety and efficacy data and claims;
- Excellent verbal and written communication skills, including technical drafting skills;
- Exceptional team building and partnering skills to collaborate with other members of the corporate law department in the US and abroad to build high functioning, efficient, trusted, cohesive, supportive law department;
- Ability to work cross-functionally, and in a matrixed environment, and build consensus among various stakeholders while maintaining a compliant approach;
- Solid ability to pro-actively identify and mitigate risks and to and identify and to address inefficiencies through continuous improvement orientation;
- Ability to work with minimal supervision and prioritize conflicting demands from multiple clients (including senior executives) in a very fast-paced environment;
- Comfortable with having to provide clear ethical guidance in all aspects of work to a global organization;
- Persuasive presentation and counseling skills; good negotiation skills;
- Strong business sense and ability to work as a partner with business clients;
- Interest in and ability to identify need for and lead process change;
- Ability to identify and address Fraud and Abuse issues that arise in operational and business transactions.
- Experience representing medical device companies and familiarity with healthcare compliance issues strongly preferred;
- Experience with interventional medical devices strongly preferred.
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If you were eligible to this occupation, please give us your resume, with salary requirements and a resume to BAYER.
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This occupation will be opened on: Sat, 11 Aug 2012 16:37:48 GMT