Associate Counsel

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Bristol Myers Squibb is a global biopharmaceutical company committed to transforming patients’ lives through science. At the core of that mission are the talented individuals who contribute their “unique” skillsets to help us drive innovation and deliver truly life-changing drugs for our patients. As we continue to pursue that mission, we’re looking for talented professionals like you to join our team. What unique gene will you bring?

This position will report to the Executive Director, Quality Law in providing comprehensive legal advice and legal partnering on GxP matters, including regulatory and compliance matters associated with quality issues. Responsibilities will also include GxP legal training and assisting on regulatory inspections, responses and strategy.

Roles and Responsibilities:

Proactively advises and counsels clients in Quality organization to resolve issues relating to GxP matters including GMP, GCP, GDP and GLP.

Responsible for providing legal advice on Quality matters and support for Quality-related compliance investigations and interfaces with outside counsel, as needed.

Identifying and managing legal risk, particularly GxP regulations.

Provide strategic legal advice across a diverse range of product categories, including pharmaceuticals, cell therapy, biologics and medical devices.

Guide and shape FDA and state inspection preparedness and support for communications with regulatory agencies.

Managing regulatory inspections and interactions with health authorities, including FDA and state inspection preparedness and related communications.

Possess strong business acumen and ability to work effectively and efficiently with limited supervision.

Actively contributes to the team through participation in discussions, sharing best practices, collaboration on projects, training, etc.

Requirements:

Law degree from recognized university. Current license to practice.

3-5 years' experience in a legal role, preferably in a major law firm, government agency or corporation.

Understanding of health care industry. Pharmaceutical quality and manufacturing background would be helpful.

Excellent communication, organizational and interpersonal skills.

Service oriented approach to client groups, with creative, thoughtful and practical problem-solving skills.

Ability to take ownership of issues and provide impactful, practical advice.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com