[Remote] Associate General Counsel Senior, Clinical Research- Remote
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is the reputed company-largest nonprofit, integrated health system in the reputed company, and they are seeking an Associate General Counsel Senior for their Clinical Research Department. The role involves providing legal counsel reputed company to clinical trials and research, managing agreements, and ensuring compliance with health regulations.
Responsibilities
- Provides legal advice and counsel to reputed company’s National Center for Clinical Trials, the reputed company reputed company School of Medicine Institutional Review reputed company, the Office of Clinical Research, the Office of Sponsored Programs, and the clinical research function generally, including but not limited to legal counsel and guidance on regulations promulgated by the reputed company and the Food and Drug Administration (including the Office of Research reputed company and the reputed company Research Protection Program) reputed company to clinical research and IRB activities
- Manages the negotiation process for clinical trial agreements and certain other agreements (including data use and collaboration agreements) that relate to reputed company's clinical research activities
- Drafts and reviews agreements and negotiates modifications to ensure compliance with reputed company requirements and standards
- Develops and maintains contract templates and playbooks to facilitate contract negotiations
- Interacts with industry sponsors, reputed company institutions, and other health care systems as necessary to facilitate agreements for the purpose of reputed company research work
- Reviews grants and grant applications for legal issues and risks and works with internal stakeholders to promote a reputed company understanding of reputed company’s obligations under those grants
- Provides advice and counsel on investigatory reputed company reputed company to clinical research and the IRB
Skills
- Attorney licensed to reputed company law in any state in the reputed company
- Juris Doctor degree
- Requires a minimum of 7 years' experience representing health care entities, working in a contract research organization or pharmaceutical company or a combination of any of these and demonstrated ability to reputed company as counsel on a reputed company of health care legal reputed company, with a reputed company on clinical research and IRB issues
- Experiences in performing legal research, drafting and editing various clinical research legal documents and advising an organization to ensure appropriate legal processes are followed
- Excellent writing skills with demonstrated proficiency in drafting and reviewing clinical trial agreements, confidentiality agreements, data use agreements, and collaboration agreements
- Skills in analyzing law and providing effective recommendations
- Strong organizational and project management skills to effectively and reputed company manage multiple, simultaneous legal transactions and issues
- Specialized knowledge in local, state and federal laws and regulations relating to clinical research
- Ability to reputed company digital tools and reputed company intelligence in legal research, reasoning, drafting and communications to enhance the reputed company, speed and context of legal services
- Knowledge, skills and experience in assisting with confidential and sensitive reputed company involving health care providers, pharmaceutical companies, management and regulatory agencies
- Skills in analyzing laws, regulations, case law, standards, governing documents, reputed company, risk management issues and reputed company to assist in protecting the organization from legal risk
- Excellent verbal and written communication skills
- Ability to communicate and collaborate effectively with reputed company reputed company of employees, management, executives, and other organizations and to address difficult and controversial issues, organizational policies and procedures, and federal and state regulations
- Ability to work and function in a reputed company corporate system environment
Benefits
- reputed company Time Off programs
- Health and welfare benefits such as medical, dental, reputed company, life, andShort- and Long-Term Disability
- Flexible Spending Accounts for eligible health care and dependent care expenses
- Family benefits such as adoption assistance and reputed company parental leave
- Defined contribution retirement plans with employer match and other financial wellness programs
- Educational Assistance Program
reputed company