Senior Manager RM
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
Assume significant role in RM activities including performing signal management activities; responding to regulatory agency queries; preparing periodic safety documents (PSURs, RMPs, etc). May assume role of RM Lead for assigned compounds
Essential Functions required for the job. List both technical and managerial requirements if applicable.
With support from Risk Management Lead or Head of RM:
1. Monitor the safety profile of assigned compounds to identify safety signals, and develop and execute a plan for their evaluation.
2. Author regulatory documents for assigned compounds
3. Prepare and deliver presentations at SMT meetings; participate in Dose Escalation meetings
4. Participate in other risk management activities as appropriate for assigned compounds.
5. May represent Risk Management for assigned compounds on cross-functional teams, including Regeneron Safety Oversight Committee, Independent Data Monitoring Committees and other teams with members external to Regeneron
6. Actively participate in the development and maintenance of relevant SOPs and supporting documents.
7. Actively participate in process improvement activities within PVRM.
Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments. Ability to utilize PVRM safety system database for purposes of medical case review and simple queries. Ability to effectively communicate (verbal and written) safety findings.
Required Licenses & Certificates:Board certification preferred
Minimum Years of Experience: Please be as specific as possible. Previous safety or relevant clinical experience in the pharmaceutical industy required, typically with at least 5 years of risk management or relevant clinical experience in pharmaceutical/ biotech industry.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: 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 will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.