Senior Counsel, Clinical R&D Legal
Senior Counsel, Clinical R&D Legal
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Salary Not Disclosed
1 Vacancy
Job Description
The Senior Counsel Clinical R&D Legal will be an integral part of a team of attorneys and paralegals providing legal regulatory and business advice to support AbbVies R&D Therapeutic Areas within the organization. In this role the Senior Counsel will be expected to effectively partner with research & development management clinical study teams business stakeholders and third-party partners. A successful Senior Counsel Clinical R&D Legal will be creative strategic and efficient in helping AbbVie develop the worlds most innovative therapeutics.
Core Job Responsibilities:
The Senior Counsel Clinical R&D Legal will be responsible for identifying and resolving complex legal issues regarding the design and execution of clinical trials the regulatory submission of data resulting therefrom and issuance of formal or informal guidance from regulatory agencies. The responsibilities of the Senior Counsel Clinical R&D Legal will include:
- Advising the Clinical Development Organization in connection with global research activity from initial concept and trial design through all phases of clinical development including the legal regulatory implications of company decision-making activities regarding the design and execution of clinical trials.
- Providing advice on complex situations that arise from clinical research including advising on legal standards and expectations regarding studies needed to support product approvals data integrity and digital health.
- Partnering with cross-functional teams in the design and execution of strategic initiatives in response to the advice provided above.
- Providing clear recommendations and advice to clients including legal leadership focused on maximizing the potential of our pipeline.
- Serving as recognized expert for both management and other AbbVie attorneys of innovative ideas in complex areas of regulatory law business technology and research.
- Working to consistently strengthen and improve agility prioritization and innovative thinking among key cross-functional partners.
Qualifications :
Requirements:
- Law degree from an ABA accredited law school and in good standing with the state bar of the jurisdiction in which your office will be located (or ability to gain licensure in the state in which your office will be located).
- 6 years of experience with a focus on regulatory or life science law some in-house experience preferred.
- Fluent in medical and scientific research concepts and terminologies critical to the successful design and execution of studies intended to support approval of globally regulated products and familiarity with FDA and international laws and regulations impacting clinical trial research such as the laws and regulations relevant to the availability of non-patent regulatory exclusivities pediatric plan design and execution and regulatory approval standards.
- Ability to support the achievement of pharmaceutical business objectives by providing clear and practical counsel including evaluating and managing risk.
- Ability to use legal training to maximize business opportunities.
- Have excellent legal analysis skills be a crisp concise communicator and ability to identify and quickly address material issues.
- Strong interest in science and the development of innovative medicines
Recommended:
- Demonstrated ability to work effectively in high-pressure matrixed environments.
- Experience in covering an array of topic areas and adapting to new subject matters and arenas in a rapid and effective manner.
Additional Information :
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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No
Employment Type :
Full-time
Employment Type
Full-time