Responsibilities
- Development and implementation of clinical regulatory strategies and tactics,including but not limited to, Modeling Informed Drug Development (MIDD), real- world data (RWD)/real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets,while considering FDA and other health authority clinical and regulatory requirements.
- Provide critical evaluation and review of clinical documents to support successful execution of regulatory objectives; proactively identify potential risks and develop implement mitigation strategies.
- Interact with and support the Azurity Clinical Development and Medial Affairs teams to review clinical protocols and other documents; provide regulatory clinical strategic input.
- Preparation and presentation of research data and findings on clinical/regulatory strategy to Azurity Executive and Senior Leadership to gain alignment on proposed regulatory strategy.
- Demonstrate knowledge and understanding of integrated data from clinical trials including but not limited to efficacy, safety, pharmacovigilance, and clinical pharmacokinetics.
- Participate/lead FDA and Health Authority interactions regarding clinical regulatory aspects, including formal meetings.
- Mentor, develop and act as a trusted advisor to coach members of the regulatory team regarding clinical strategy and writing; this position may or may not have direct reports.
Benefits
- Unlock Your Earning Potential: Join our team and be rewarded with a competitive compensation package, including an annual bonus based on company performance, that recognizes your exceptional talent.
- Sales - In lieu of annual bonuses, we offer an Incentive compensation program that allows you to earn more - even over plan.
- Fuel Your Success: *Sales Only* - We understand the value of your hard work and provide a car reimbursement program and gas card for both business and personal use as part of our commitment to supporting you.
- Comprehensive Health Coverage: We value your well-being and offer excellent medical, dental, vision, and prescription coverage to ensure you and your family are always taken care of.
- Flexibility for Your Lifestyle: Achieve work-life balance with our hybrid work model, allowing you to work two days from home and three days in the office. *Excludes Sales, Manufacturing, and some Operations positions*
- Invest in Your Future: Our Retirement Savings Plan (401K) is designed to help you secure a comfortable retirement by matching dollar for dollar up to 5%.
- Time Off That Counts: Take advantage of our generous time off policy, which offers up to 15 vacation days annually + rollover (up to 40 hours) as well as five sick/wellness days. For new employees, vacation accrual will be prorated based on your start date.
- Meaningful Time with Your Loved Ones: We close between Christmas and New Year’s to give you an extra week off to spend quality time with your family and recharge.
- Enjoy the Holidays: Over the course of the year, Azurity recognizes 13 holidays.
- Invest in Your Education: We support your professional growth with tuition reimbursement for undergraduate and graduate level courses or certifications.
- Recognize and Be Recognized: Our Azurity High Five peer recognition platform allows you to celebrate your colleagues' accomplishments and receive recognition for your own outstanding work.
Work Arrangement
Hybrid
Additional Information
- Must be able to sit for long periods of time.
- While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear.
- May occasionally climb stairs and/or ride elevators.
- The employee must occasionally lift and/or move up to 25 pounds.
- Employee must be able to manipulate keyboard, operate a telephone and hand-held devices.
