Job Details

Food & Drug Administration Attorney in Gaithersburg, MD

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Company name

MedImmune, LLC.

Organization Type

In-House

Job Type

Attorney

Practice Area

Food & Drug Administration

Years of Experience

Min 2 yrs required

Location

USA Gaithersburg, MD

Date Last Verified

Apr 23,2018

Posted on

Mar 15,2018

106 hits

Profile

Legal Advisor/Senior Legal Advisor Duties: Responsible for the efficient execution of business processes for the technical functions (Research and Biopharmaceutical Development) and Operations groups. Supports additional groups including Global Medicines Development, Innovative Medicines, Global Product and Portfolio Strategy and Global Medical Affairs. Provides practical, timely, quality legal services to help the Company meet its business objectives through deep understanding and compliance with all applicable laws, rules, and regulations. Interacts with and must be able to influence all levels of the organization. Draft and negotiate various contract types (e.g., Material Transfer Agreements, Studentships, Fellowships, Post-doc Research Agreements, Research Collaborations and others) using approved templates in accordance with pre-defined target cycle times. Draft basic contract language when needed and prepare modifications for review by legal department as appropriate. Review contract drafts (e.g., service agreements, HCP engagement agreements) provided by Contracts Managers and Contracts Specialists for consistency with policies. Review contract drafts provided by external parties for consistency with terms and conditions. Provide legal advice, mentoring, and coaching of Contracts Managers, Contracts Specialists and other team members as needed. Set and appropriately modify priorities based on feedback from internal clients. Effectively multi-task to manage priorities across contracts. Manage client and third-party expectations and deliver results within reasonably established timelines. Work with internal and/or external business teams on issues and developments related to assigned contracts. Consult with various stakeholders from other departments (Procurement, Legal, and Compliance) as appropriate. Communicate effectively with customers and team members who lack legal expertise. Actively participate in projects to support the simplification of overall drafting and negotiation process and related systems. Identify opportunities to improve the contracting process to increase efficiency or to better manage risk. Additional duties for Senior Legal Advisor: Identify training needs within the organization and develop/present training materials on relevant laws and legal/business issues. Assist in the continuous improvement of contract templates. Lead projects to support the simplification of overall drafting and negotiation process and related systems. Ensure consistency of quality of agreements among legal advisors. Serve as liaison with legal department to align on policy and standards.

Qualification and Experience

Qualifications: A JD Degree is required. Bachelor’s Degree in a scientific field is preferred. A degree in Business, Finance, or related field will be considered. 2+ years of experience drafting, reviewing, and negotiating a range of biopharmaceutical industry-specific agreements including CDAs, service agreements, and material transfer agreements. Experience with sponsored research agreements and research collaborations preferred. Experience in a biotech or pharmaceutical R&D organization, or a university or government technology transfer office. 5+ years of experience drafting, reviewing, and negotiating a range of biopharmaceutical industry-specific agreements including CDAs, service agreements, material transfer agreements, sponsored research agreements and research collaborations. Knowledge and resolution of IP issues that arise in contracts. Experience in a biotech or pharmaceutical R&D organization, or a university or government technology transfer office. Thorough understanding of the business and legal aspects of contracts used for drafting, reviewing, negotiating and closing agreements, with an eye to mitigating risk for the Company while coming to mutually agreeable terms, with commercial vendors, federal and state governments, and academic and non-profit institutions Must have strong initiative as well as excellent management, teamwork, delegation and problem-solving skills. Ability to work independently with minimal supervision. Ability to interact effectively with individuals at all levels of the organization, up to and including senior leadership. Strong customer support orientation and ability to explain complex issues in simple terms. Thorough understanding of the contract process including contract evaluation, negotiation, approval, tracking and close-out. Superior oral and written communication skills. Ability to influence and negotiate to a mutually acceptable. Flexibility and willingness to learn new systems and procedures.

Additional info

Ref-024406

Company info

Hiring Coordinator
MedImmune, LLC.
One MedImmune Way
Gaithersburg, MD 20878