- Provide strategic advice and comprehensive legal counseling to WKH senior executives and WKH teams regarding regulatory requirements and risk management in healthcare and HIT product development, including legal trends and issues related to HIPAA/HITECH Act compliance, HIT developments and regulatory rulemaking and initiatives.
- Remain up-to-date with regulatory and industry developments and (i) anticipate needed changes to our offerings and processes and legal and business risks associated with new product development, and (ii) communicate recommendations to senior business leaders and advise on acceptable risk levels in line with the company's business objectives.
- Work closely with WKH's management to identify and mitigate contractual and regulatory exposures and risks related to (i) development of new customer offerings, (ii) promotional or marketing activities for WKH offerings, (iii) sales practices, (iv) data protection and cybersecurity risks across different offerings, and (v) international market expansion (including multi-national anti-bribery/anti-corruption regulations, export and embargo restrictions, medical device regulations and privacy/security regulations).
- Effectively and efficiently manage outside counsel (in the US and abroad) supporting transactional, litigation and/or compliance matters, and collaborate and work closely with other attorneys within the GLCD in areas such as litigation, human resources/employment or benefits matters, specialty IT/IP areas or M&A transactions.
- Develop an in-depth knowledge and understanding of WKH, its people, organization, markets, offerings, customers, competitors, and regulatory environment, in order to identify trends, stay abreast of material developments and provide legal advice to the businesses on emerging opportunities and risks.
- Develop a strong rapport and working relationship with WKH senior executives and our teams to help drive the delivery of effective and high-quality legal services.
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Managing Legal Counsel, Health Division - Waltham, United States - Wolters Kluwer
Description
The Managing Legal Counsel will focus on assisting Wolters Kluwer Health ("WKH") navigate the complex regulatory environment for healthcare and health information technology (HIT) in the United States and globally.
The Managing Legal Counsel will serve as WKH's subject matter expert in this area and will advise the business on regulatory matters involving, among other things, global regulation of software as a medical device, HIPAA/HITECH Act and other healthcare privacy regulations (including as applied to data de-identification and data analytics) and pharmacy/pharmaceutical regulations.
The Managing Legal Counsel will provide legal advice and support on issues concerning the rights, obligations, and privileges of the organization and will help resolve highly complex business or technical issues by identifying pragmatic legal solutions and recommending a course of action.
The Managing Legal Counsel position can be based at WKH's offices in Waltham, MA or Riverwoods, IL. For the right candidate, remote work will be considered.
The position will be part of the Wolters Kluwer Global Law and Compliance Department (GLCD) and will report to the VP & Assistant General Counsel for the Health Division of Wolters Kluwer.
Specific accountabilities and responsibilities are expected to include the following:EDUCATION AND EXPERIENCE:
Candidates are required to have both a bachelor's degree and law degree (J.D.), with academic distinction, from highly regarded, nationally recognized educational institutions.
The successful candidate will have ten (10) or more years of progressively responsible corporate/commercial legal experience, preferably including experience with both a top-tier law firm and an established corporate law department.
This experience should include, among other things, hands-on legal work on a variety of domestic and international healthcare and healthcare privacy regulatory matters.
The Managing Legal Counsel must have, among other things, a strong background in and understanding of innovative HIT and digital health concepts as well as a general understanding of software licensing and SaaS subscription arrangements.
The Managing Legal Counsel must also have a strong understanding and awareness of the healthcare laws and regulations that impact the operations of Wolters Kluwer Health and its product development strategy and must keep current with their evolution in order to provide comprehensive and up-to-date legal advice.
