Temp - Associate Director

Location
Tarrytown, NY
Posted
Oct 18, 2018
Ref
14286BR
Required Education
Bachelors Degree
Position Type
Contract
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.

Summary:

Responsible for Risk Management (RM) activities related to individual case medical review for numerous and/ or complex compounds. Take initiative/ assume lead role in across-compound RM activities relevant to medical review. Serve as in-house expert on designated RM topics. Assume clinical research organization (CRO) medical reviewers oversight activities.

Job Duties:

Essential Functions required for the job. List both technical and managerial requirements if applicable.

With oversight from Head of RM, responsible for providing oversight to CRO individual case medical reviewers.
Review all high impact cases (e.g. fatal/life threatening SUSARs, unanticipated events, cases where investigator and company causality differ, and others as requested by vendor case management (VCM)) prior to submission to health authorities.
Work closely with RM leads and clinical development leads to provide a cohesive, comprehensive and accurate medical narrative, analysis of similar events (when applicable) and company causality rationale in individual case reports prior to health authority submission.

Resource for medical review of Regeneron compounds
Actively participate in the development and maintenance of relevant SOPs and working practices
Actively participate in process improvement activities within PV and RM (as applicable)
Expertise with PV databse
Requirements:

Ability to apply and provide critical analysis of relevant clinical information for both clinical trial and post-marketing SAE and AESIs. Function as a medical review expert internal and external to PVRM for Regeneron compounds. Ability to utilize PVRM safety database for purposes of medical case review and simple queries. Ability to effectively communicate (verbal and written) medical rationale and defend recommendations in safety narratives.
Strong clinical acumen with expertise in individual case reviews. Ability to manage external vendors and liase with Regeneron clinical and risk management team.

MD
Clinical experience and 5+ years of industry experience in drug safety including significant experience with medical review of individual cases.

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.