Legal Counsel - R&D Avanir Pharmaceuticals
This attorney will focus on advising the Research & Development (R&D) department on a variety of activities such as pre-clinical and clinical matters, regulations for investigational and approved products, regulatory submissions, CMC (supply, manufacture, and quality issues), drug safety management, labeling and label modifications, clinical studies Phase I through Phase IV, and other late stage development programs.
ESSENTIAL JOB FUNCTIONS
Advise R&D clients on a broad array of issues relating to pharmaceutical regulations, product development, and product labeling.
Draft, review, and negotiate contracts for all aspects of R&D.
Direct client responsibility in support of a broad range of company R&D activities.
Advise R&D on recent developments in risk management requirements.
Conduct legal research involving pharmaceutical licensing and clinical trials.
Partner with internal compliance team to ensure compliance with applicable laws, rules, regulations and guidance, including but not limited to anti-kickback and anti-bribery laws, privacy law, Sunshine Act, PhRMA Code, safety reporting, and post-marketing matters.
General Essential Job Function Skills include:
Strong decision making skills
Good negotiating skills
Ability to work independently as well as the ability to work well as part of a team
Ability to recognize and effectively communicate legal issues
5+ years experience with legal, regulatory and compliance requirements in the pharmaceutical industry.
Broad-based knowledge of laws and regulations governing pharmaceutical activities with a focus on research & development and regulatory areas.
Keen interest in R&D matters.
Must have a solid working knowledge of FDA and EMA regulations and issues.
Must have strong interpersonal and communication skills, together with proven ability to work as part of a cross-functional team and interfacing with senior business leaders.
Must have proven skills in analyzing and solving complex legal issues and in managing complex legal projects.
Candidates should be licensed to practice law in California or another jurisdiction.
Large law firm training or prior pharmaceutical or biotech experience.
JD from an accredited law school
Strong academic credentials
Excellent written and verbal communication skills
||101 Enterprise |
Aliso Viejo, CA 92656