- Develop and oversee the company's healthcare compliance program, including policies, training, and monitoring/auditing activities, to achieve effective internal controls and oversight in the United States, Europe, and other territories
- Partner with cross-functional company leadership to develop, implement, and maintain policies and systems that prevent violations of law, regulations, and company policies, while enabling operational excellence
- Serve as an independent voice and source of information on matters of compliance for the company's CEO and Board of Directors
- Structure and scale the future growth of the compliance group to match the company's growth and needs
- Establish relationships and serve as a strategic business partner to cross-functional leads and senior management to drive a culture of compliance across the Company
- J.D. from an accredited law school
- Admission to a state bar and active license to practice required
- 10-15 years of legal experience - whether law firm or in-house - with at least 5 years of experience as a healthcare compliance professional at a pharmaceutical or biotechnology company supporting marketed products preferred
- Experience building, implementing, and continuously improving a compliance function
- Experience developing and implementing strategic initiatives that align with business goals within established budgets and timelines
- Expertise in FDA advertising and promotions requlations, False Claims Act, Anti-Kickback Statute, OIG guidance, and the PhRMA Code
- Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Prothena's culture and values - courageous, imaginative, selfless, and joyful
- Ability to understand the science behind the company's product candidates and the product development process
- Excellent verbal and written communication skills, including interpersonal skills
- All Prothena employees (and their families) are covered by medical, dental, and vision insurance, with Prothena paying ~90% of plan premiums.
- Prothena pays the full premium for basic life and disability insurance for all employees.
- Prothena employees are also eligible to enroll in our Company's 401(k) plan and are always 100% vested in their account balances. The 401(k) plan provides for a quarterly, non-discretionary, 3% company-paid contribution on eligible earnings, as well as an additional, annual discretionary Company match of up to 2% of eligible earnings.
- New Prothena employees are also eligible for 17 days of paid vacation accrued over the course of the first year of employment, paid sick time in accordance with state law, and company-paid holidays - which includes a Company-wide shutdown at the winter holidays.
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Associate General Counsel, Head of Global Compliance - South San Francisco, United States - Prothena Biosciences
Description
Position Overview:
Reporting to the Chief Legal Officer, the Associate General Counsel, Global Head of Compliance, will serve as the senior legal advisor on compliance matters related to product development; sales, marketing and promotion; medical education and medical affairs activities; patient access programs; government price calculation and reporting; privacy and data management; and all other aspects of compliance with pre-commercial and commercial activities.
Responsibilities:
Requirements:
Education and Experience:
Competencies and Attributes:
Compensation Overview:
The anticipated annual salary range for this role as the Associate General Counsel, Head of Global Compliance job level is $300,000 to $355,000.
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting.
We may ultimately pay more or less than the posted range, and the range may be modified in the future.
The final salary offered to a successful candidate will be dependent on several factors that may include - but are not limited to - the final job level offered, the type and length of experience within the job and industry, relevant education, qualifications, skills, certifications, performance, and business or organizational needs.
The hired applicant will be eligible to receive an annual bonus and an equity grant in the form of stock options.
Health & Wellness Benefits, 401(k) and PTO Overview:
