Regulatory Specialist Or Director Of Regulatory Sciences

Profile

Regulatory Specialist or Director of Regulatory Sciences

Duties: Develops, coordinates, and provides biostatistical support for projects related to the development of FDA-regulated medical products, including medical devices, pharmaceuticals, and biotechnology products. Interacts with product sponsor teams (e.g., Clinical, Regulatory, Statistical Programming, Data Management, and other Research & Development Scientists) in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical medical device, drug, and biologic projects. Serves as statistical representative for the law firm on the cross-functional teams for the clinical trial planning and execution. Advises sponsors on appropriate statistical methodology for data analysis; when necessary assists in developing protocols and data analysis plans. Analyzes data and interprets results from clinical trials to meet objectives of the study protocol. Prepares written reports to effectively communicate clinical trial design and results to regulatory agencies (e.g., drafting clinical study reports, clinical sections of marketing applications and FDA briefing materials, etc.). Provides assistance in drafting and revising medical device premarket submissions, such as Requests for Designation, 513(g)s, Pre-Submission requests, Investigational Device Exemptions (IDEs), 510(k) notices, and/or premarket approval applications (PMAs). Provides assistance in drafting and revising submissions for pharmaceutical and biotechnology products, such as Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and Biologics License Applications (BLAs). Helps prepare responses to queries relating to study design, analysis, and interpretation posed by regulatory agencies.

Additional Information

Job Requisition ID: R223319 Send resume.

Company info

Hogan Lovells
100 International Drive Suite 2000
Baltimore
Maryland
United States 21202
Website : http://www.hoganlovells.com