As part of Penumbra’s legal team, the Life Sciences Counsel will support a growing and dynamic company that develops ground-breaking technology to further its mission of saving patients’ lives. You will work closely with other seasoned attorneys, paralegals, and support staff as part of this closely-knit team while partnering with external departments essential to the Company’s operations.
What You’ll Work On
• Provide strategic advice, legal direction, and training on applicable laws and regulations related to the advertising and promotion of medical devices; offer regular updates to key stakeholders as relevant regulatory authorities update guidance and as enforcement activities develop.
• Support all legal aspects of clinical trial programs, including assessment of related risks and creation of efficiencies across clinical trial programs.
• Provide pragmatic, business-oriented advice to Company management and key department stakeholders, including close coordination with Sales and Marketing, Regulatory, Clinical Research and Finance.
• Review and negotiate a variety of contracts, including vendor agreements, regulatory service agreements and clinical trial agreements.
• Partner with Legal Operations and Privacy teams to ensure all relevant issues are addressed consistently and to continue fostering efficiencies across the department.
• Work closely with a collaborative team of paralegals, contract specialists and administrators professionals in the day-to-day contract drafting and negotiation process, adding to a positive and productive working team dynamic.
• Help to shape and continuously improve contract templates and playbooks.
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
• Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company.
• Ensure other members of the department follow the QMS, regulations, standards, and procedures.
• Perform other work-related duties as assigned
What You Contribute
• Juris Doctorate and membership with the California Bar, or at least one other state’s bar, and the ability to obtain registered in-house counsel status with 6+ years of experience, or equivalent combination of education and experience
• 6+ years of relevant legal experience, with at least 4+ years of experience advising on clinical contracting and/or regulatory matters in-house
• Medical device, pharmaceutical, biotech, or other regulated industry experience strongly desired
• Sound judgment; demonstrated analytical, oral, and written communication abilities; and excellent interpersonal skills
• Experience in advising clients and/or internal business departments on relevant regulatory and healthcare compliance-related issues, including Anti-Kickback Statute, False Claims Act and current FDA and OIG guidance
• High degree of accuracy and attention to detail
• Proficiency with MS Word, Excel, and PowerPoint
• Proven ability to prioritize assignments while handling various initiatives and projects simultaneously
Working Conditions
General office environment. Willingness and ability to work on site. May have business travel from 0%-10%. Potential exposure to blood-borne pathogens. Requires some lifting and moving of up to 15 pounds. Must be able to move between buildings and floors. Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day. Must be able to read, prepare emails, and produce documents and spreadsheets. Must be able to move within the office and access file cabinets or supplies, as needed. Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.
Annual Base Salary Range: $161,000 - $220,000
We offer a competitive compensation package plus a benefits and equity program, when applicable. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.
What We Do
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
Members of the Penumbra team agree that this is where their work has meaning -- we are transforming the treatment of some of the world's most devastating conditions. Penumbra is where everyone's ideas matter, and where learning and growth are constant.
