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Senior Associate, Regulatory Informatics

Location San Rafael, California

JOB DESCRIPTION

Job Title:

Senior Associate, Regulatory Informatics

Department / CostCenter:

Pharmacovigilance – 219

Reports to (Job Title):

Associate Director, Regulatory Informatics

Job Code:

TBD-

Location:

Novato

Date Prepared:

03 January 2019

Full-Time     Part-Time

Regular     Temporary

Exempt     Non-Exempt

SUMMARY DESCRIPTION

State the overall function or purpose of the job.

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

List the major responsibilities of the job.

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.

SCOPE

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EDUCATION

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Bachelor’s Degree desirable. 

EXPERIENCE

State both the minimum and the preferred number of years of relevant experience, and describe the essential functions of the job.

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 systemswith 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.

WORK ENVIRONMENT / PHYSICAL DEMANDS

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The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.

EQUIPMENT

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CONTACTS

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The candidate must interact with personnel from Regulatory Operations, Regulatory Affairs, authoring departments (including but not limited to, Quality, Clinical, Nonclinical, etc.), IT, QA, and project team members from BioMarin as well as partner company(ies).

SUPERVISOR RESPONSIBILITY

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Not applicable

CAREER DEVELOPMENT

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About our location

San Rafael

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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