At Horizon Therapeutics, we define success by the number of lives touched, lives changed, and lives saved. Our global biotechnology company is made up of agile, out-of-the-box thinkers with a focus on delivering breakthrough medicines to those living with rare, autoimmune, and severe inflammatory diseases. This is the heart of our global mission. Start a career that enables you to live up to your potential and help others live up to theirs. Join us.
The exceptional support we provide patients and communities equally extends to our employees. We offer industry-leading and award-winning benefits, compensation and rewards programs that positively impact all areas of our employees' personal and professional lives.
Position Summary
We are seeking a motivated, detail-oriented individual to provide operational support to the non-clinical safety team at Horizon Therapeutics. The successful candidate will have experience with the contract research organizations (CRO) or pharmaceutical industry or both, as well as a familiarity with non-clinical safety studies, Good Laboratory Practices (GLPs), and general pharmaceutical development. The individual's primary responsibility will be supportingnon-clinical safety operational activities, timelines, and contract activities and conducting quality review of study reports and regulatory documents.
Responsibilities
- Develop and maintain relationships with CROs and other external collaborators.
- Establish and maintain confidentiality disclosure agreements (CDAs) and master service agreements (MSAs) between external vendors and internal legal team
- Liaise with CROs and external vendors to request bids/proposals for non-clinical safety work
- Monitor and process the generation of work orders/purchase orders and the payment of invoices for non-clinical safety work
- Review and track timelines of contracted studies, including milestone payment dates and cancellation dates and fees
- Review regulatory documents such as study reports, INDs, and consultant reports against raw data for accuracy
- Ensure the timely and accurate transfer of study samples, data, and study documents between internal and external collaborators
- Assist in managing the review of regulatory documents by circulating documents for review and collecting and collating comments for approval by non-clinical safety scientists
- Interact/collaborate closely with other Horizon Therapeutics functional areas such as Bioanalysis, CMC, and Clinical Pharmacology for various activities
- Anticipate, troubleshoot and suggest solutions for issues that arise and appropriately escalate as needed for resolution
Qualifications and Skills Required
- Bachelor's or Master's degree with 2+ years of industry experience.
- Understanding of Good Laboratory Practices (US FDA 21 CFR Part 58)
- Understanding of the drug development process
- Familiarity with regulatory guidelines and documents
- Experience in contracting and supporting work with external service providers
- Detail-oriented ability to review and QC documents
- Excellent communication, organization, and interpersonal skills
- Proven ability to work independently and to collaborate effectively with a diverse team
- Proficient in Excel data tables, pivot tables/figures, and macros.
Our Values
- Transparency: We value collaboration. Trusting teach other and tackling tough challenges can make a powerful difference.
- Accountability: We do what's right for our patient communities through quality decisions and owning our successes and failures.
- Growth: We fiercely innovate and evolve to better ourselves, our communities and our patients.
These three values come to life through our five Leadership Expectations that apply to all Horizon employees
- Enterprise Mindset: Look beyond one's team, brand or function to see the broader company and external perspective
- Exhibit Intellectual Curiosity: Seek to understand what you do not know; ask the right questions of the right people and sources
- Ensure Accountability and Courage: Step up to address difficult issues and hold self and others accountable to commitments
- Embrace Diverse Perspectives: Welcome others with a respectful attitude; integrate diverse perspectives into ways of working
- Develop Talent: Provide feedback, coaching and mentorship to help others be more effective in their role
At Horizon, we know that disease does not discriminate. We embrace the bold ideas of one another, foster a sense of belonging, and value inclusion. We attract and develop diverse talent because we believe that when people from different backgrounds and life experiences come together, we make lives better.
Horizon intends that all qualified applications are given equal opportunity, and that selection decisions be based on job-related factors. We do not discriminate based on race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristics protected by law.
|
Horizon Therapeutics
July 13, 2023