Job Description
Who We Are For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more. And the more people we reach, the more our impact can grow. We transform lives through genetic discovery. Our Culture Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard \u2013 so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients. By providing a foundation for all operations company wide, BioMarin\u2019s General and Administrative teams support our mission of providing first and best in class therapeutics to patients who live with rare diseases. Our teams include groups such as finance, legal, human resources, corporate compliance and ethics, and information technology. Come join our team and make a meaningful impact on patients\u2019 lives. Summary/Job Purpose:Works with Senior Attorney to provide legal support to Worldwide Research and Development (WWRD) teams responsible for executing global Phase 1 through 4 studies and operations.\u00A0Essential Duties and Responsibilities:Draft, negotiate and advise on global Phase 1 through 4 WWRD contracts, including confidentiality agreements, CRO and other clinical vendor or consulting agreements, and clinical trial and registry agreements.Independently review and provide input regarding clinical trial-related documents, such as informed consent forms and related clinical trial related submission and privacy documents and serve as an internal legal resource to WWRD. Identify and define legal risks and communicate those risks to appropriate internal decision-makers for discussion and resolution.Interact with internal clients efficiently and effectively to address legal questions.Interface with clinical research organizations, hospitals, and universities to facilitate clinical trials.Serve as first point of contact for escalation of contract related matters by contracts associates.Responsible for creation of contract related resources (templates, playbooks, contract guides).Perform training for contracts associates and business partners on contract related issues.Handle miscellaneous legal tasks on an as-needed basis under direction of senior attorneys.Education/Experience:Juris Doctor degree from nationally recognized law school with excellent academic credentials.Member in good standing of the CA Bar or eligibility for In-House Counsel Certification required.A minimum of three years of experience as an attorney in a law firm or in-house legal environment in the biotechnology or pharmaceuticals industry.BS/BA degree.Contract, template, and playbook drafting and negotiation experience required; Clinical trial contract drafting and negotiation experience preferred.Experience and familiarity with ICH GCP R6(E2), FDA and EMA law and regulation governing Phase 1-4 clinical research preferred.Knowledge/SkillsExcellent verbal and written communication skills.Strong computer skills (e.g., Microsoft Office Suite (Word, Excel, PowerPoint, etc.) and Contract Management Systems).Must be detail-oriented and have strong organizational skills.Ability to handle multiple tasks simultaneously with the ability to re-prioritize on short time frames.Works well under pressure to meet specific deadlines.Must have excellent judgment with the ability to assess risks and benefits (determining what risks are acceptable) and determine the best path to achieving desired results.Self-starter with the ability to work independently as well as collaboratively in a team environment.Dedicated to quality, reliability, and highest professional standards in all work tasks. PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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