Senior Associate, Regulatory Informatics

Location:  San Rafael, California Category: Regulatory

Description

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.

Summary

This position’s primary focus is the support of Regulatory Informatics processes and systems, including Regulatory Submissions, Regulatory Information Management, and Validation processes and a range of Regulatory Submission Publishing, Viewing, and Archiving systems. 

 

Responsibilities

Business Analysis and Project Management

Able to liaise with stakeholders to understand business system and process requirements to recommend solutions to achieve Regulatory Information Management goals. Able to independently manage small technical projects.

 

Regulatory Intelligence

Advanced understanding of regulations and guidances associated with submissions and their impact on Regulatory systems and Regulatory Information Management.

 

Communication

Able to answer some technical questions for many submission types.

 

Group Representation

Participate in team and sub-team meetings, volunteer for action items and participate in issue resolution.

 

Technical Support

Able to answer most technical questions for many submission types. Able to troubleshoot and resolve some issues with critical computer application systems, e.g., InSight platforms.

 

Experience

The candidate should have at least 3 years of experience in Regulatory Operations/Informatics OR at least 2 years of experience in Regulatory Operations, InSight certification, and 2 years of related experience.

 

Skills Required

Advanced computer skills, especially in MS Office, Adobe Acrobat, and electronic document management systems (EDMS) experience with scanners and copiers, able to multi-task and set priorities, pay close attention to details, work in team environment.

Computer skills in the Liquent InSight platforms , Acrobat plug-ins such as ISI Toolbox, and other Regulatory Operations systems with understanding of submissions processes and electronic standards (eCTD, RPS, etc.).

Experience with Veeva Vault RIM platform desirable.

Knowledge of Computer Systems Validation processes, and ability to apply BioMarin Systems Development Lifecycle to Regulatory Information Management projects.

 

Job Level/Complexity

Uses professional concepts and company’s policies and procedures to solve a wide range of moderate problems in imaginative and practical ways.

Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

 

Management or Mentoring Required

May determine methods and procedures on new assignments

 

Education

Bachelor’s Degree desirable. 



We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.