Clinical Compliance Specialist

At Retrophin, our mission is to identify, develop and deliver life-changing therapies to people living with rare disease. Giving patients a chance, providing hope, is what drives us.

Retrophin recognizes that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of patients. Our work is rewarding, professionally and personally because we are making a difference and we are passionate about what we do.

We are seeking talented individuals with an entrepreneurial drive who will thrive in our collaborative, fast paced environment and share in our mission to help others. We are headquartered in San Diego, CA with additional offices in Dublin, Ireland.

Position summary:

The Clinical Compliance group is focused on supporting Retrophin's clinical studies and concentrates on overall compliance of regulations and processes used within, or to support, our clinical trials. The Clinical Compliance Specialist will be responsible for interfacing with our Quality Management System (QMS), supporting current Compliance staff, metrics and performance indicator management, and general Clinical Compliance work.

This full-time position requires significant cross-functional interaction, experience with MS Excel and PowerPoint, attention to detail, and knowledge of the clinical trial process and the associated regulations and guidelines.

Essential Functions:

• Responsible as the Clinical Operations point of contact for entering and managing select items within the QMS, e.g. SOP writing, deviation and CAPA entry.
• Demonstrates a clear understanding of FDA regulations, ICH Guidelines and Good Clinical Practices (GCP).
• Proactively and under the guidance of Clinical Compliance team, interfaces with other Retrophin R&D functions to coordinate relevant and timely exchange of information / materials to support clinical trials delivery.
• Track and provide report metrics as required
• Develop, merge and maintain spreadsheets and intricate data as required within Clinical Compliance.
• Assist with required organizational tasks e.g. meeting coordination, minutes, etc..
• Maintain current team list of Clinical Trial Liaison (CTL) Team members by region and country.
• Represent Clinical Compliance and provide guidance by attending all CTL calls as appropriate. Conduct meetings as needed.
• Prepare and present status updates and results on the CTL group as required.

Qualifications:

• Bachelor's degree, or equivalent, in a life science, or related field of study. Equivalent combination of education and applicable job experience may be considered.
• Three (3) plus years of clinical study project experience or clinical compliance experience in a pharmaceutical or CRO setting.
• Experience working with cross functional groups is preferred.
• Familiarity with GCPs, ICH guidelines and FDA regulations; global regulatory and compliance requirements is preferred.
• Proactive, self-starter who possesses exceptional multi-tasking and communication skills, both oral and written.
• Good problem-solving skills, a strong sense of urgency, keen attention to detail, ability to work independently and be able to effectively manage multiple priorities in an environment under time and resource pressures.
• Intermediate proficiency in Microsoft Suite required.
• Experience with Veeva Quality Management System is desired.

Retrophin, Inc. is an EEO/AA/Veteran/Disability Employer

Retrophin, Inc. is an EEO/AA/Veteran/Disability Employer