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Associate Director, Clinical Compliance
If you are looking for an uncommon opportunity -- a chance to join an organization known for its scientific excellence in the research and development of pharmaceuticals -- it's time to consider Regeneron.
Founded on the principle that strong science would lead to important new medicines, Regeneron has become an integrated biopharmaceutical company that discovers, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions.
Regeneron currently markets ARCALYST (R) (rilonacept) Injection for Subcutaneous Use and EYLEA (TM) (aflibercept) Injection. Regeneron has therapeutic candidates in Phase 3 clinical trials for the prevention of gout flares, central retinal vein occlusion, diabetic macular edema, certain cancers, and rheumatoid arthritis. Additional therapeutic candidates are in earlier stage development programs in cholesterol reduction, allergic conditions, pain, and cancer.
Reporting to the Sr. Director Clinical Compliance and Process Improvement, this position will provide guidance and leadership in the investigation, correction and preventation of potential GCP Compliance issues at investigator sites, CROs and within all Clinical Development & Regulatory Affairs. Incumbent will be responsible for developing systematic approaches and trending to ensure best practices for Regeneron and high quality/efficient/risk mitigating processes within clinical development to assure GCP compliance is integrated into our processes with a focus on the end results. Develops and provides training within Clinical Trial Management department, CROs and Investigator sites on Compliance Signal detection, corrective and preventative action plans and other specific job requirements to support - on the job - performance that ultimately impact data integrity and output.
-Lead formal potential non-compliance investigations of GCP issues as they arise, ensuring timely escalation to line management related to Clinical Management of Investigator Sites,
CROs, processes/systems according to current SOPs for non-compliance and escalation.
-Provide recommended approaches and collaborate effectively with all levels of Clinical Trial Leads, Clinical Oversight Group and other team members on investigating and developing corrective and preventative actions based on early escalation of potential non-compliance issues. Drive/oversee remediation plans and assist team with integration and follow-up of these actions as part of monitoring process.
-Work with Sr. Manager, Compliance Analysis and Trending to develop management tools to assist in ongoing evaluation/assessment of internal processes and assure ongoing continuous process improvement.
-Design, develop and present (where applicable) job specific training, training modules and/or training aids for Clinical Monitors, CROs, and CRAs.
-Assist in the development and/or training of investigators/sites as part of non-compliance investigations and/or early escalation of potential non-compliance issues.
-Support CPMO teams and leaders in preparation and/or training for FDA or other regulatory inspections of sponsors and investigator sites as needed.
-Drive results and collaborate with Clinical Team Leaders in responding to Site, Targeted, For Cause and CRO Quality Audits to assure corrective and preventative actions are identified and integrated into monitoring processes or agreements with CROs.
-Identify ways to continuously improve quality and compliance with regulations and company standards, policies and procedures through partnership within CPMO.
-Provide input as needed in the revision of processes and SOPs as part of ongoing process improvement
-Lead CPMO Process improvement teams based on compliance and performance goals within CPMO and CDRA
-Present and make recommendations to head of Compliance and management team to affect changes as needeed
Minimum Bachelors Degree a must
Extensive experience working in a highly regulated environment preferably within the pharmaceutical industry.
8-10 years experience conducting clinical trials and experience with GCPs and Clinical Compliance.
2-5 years in a training position preferably with experience specific to training of clinical and/or field monitors
Excellent communication skills and ability to work with people in all levels of the organization
Experience with FDA or other Regulatory Inspections of Investigotor sites, Sponsors or CROs.
Demonstrated experience in driving development of improvement plans to address potential non-compliance.
Demonstrated skills in taking initiative and working independently.
Proficient in Microsoft Products specifically Powerpoint and Excel
We offer a competitive compensation and benefits package including stock incentives, 401k with company match as well as the expected health and welfare benefits. Comprehensive relocation benefits are available, as required.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply to us today and find out what we mean when we say that, at Regeneron, we have an unwavering commitment to combining good science & good business.
Disclaimer: Regeneron is not accepting unsolicited assistance from search firms/employment agencies for this employment opportunity. Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the Internet or in any form and/or method without a valid written search firm agreement in place for this position will be deemed the sole property of Regeneron. No fee will be paid in the event the candidate is hired by Regeneron as a result of the referral or through other means. Moving forward, Regeneron is using the agency management company, Candex - www.candex.com
ARCALYST and EYLEA are trademarks of Regeneron Pharmaceuticals, Inc.
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