Regulatory Specialist Or Director Of Regulatory Sciences
Hogan Lovells
Tysons Corner, VA
Apply Now >
Director of Workplace Equity, Senior Counsel
The National Women's Law Center
, DC
Apply Now >
Senior Counsel, Reproductive Rights and Health
The National Women's Law Center
, DC
Apply Now >
Counsel, Education & Workplace Justice (State Workplace Policy)
The National Women's Law Center
, DC
Apply Now >
Senior Regulatory Policy Specialist
Fairfax, VA
Apply Now >
Regulatory Specialist Or Director Of Regulatory Sciences
Company name
Hogan Lovells
Experience
2 yrs required
Location
Washington, DC, United States
Employment Type
Full-Time
Industry
Legal
Posted on
Dec 05, 2022
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
555 Thirteenth Street NW
Washington
District of Columbia
United States 20004
Website : http://www.hoganlovells.com
Location : Washington, DC
Director, Global Affairs
The candidate will support the firm's engagement with national and international regulatory bodies, global conventions, relevant committees, trade associations and stakeholder groups on priority global is... Location : Washington, DC
Senior Director, Planning, Strategy and Operations, Government Affairs & Policy
The candidate will lead annual creation of operating plans, ensuring departmental priorities are aligned to business strategy or corporate objective ... Location : Washington, DC
PAC Director
The candidate will be responsible for implementing and managing multifaceted PAC campaigns and political resources (including developing and executing a planned strategy by meeting deadlines, oversight of contract em... 
Employer job 
90 Day Old Job 