Senior Associate, Regulatory InformaticsLocation San Rafael, California Apply
Senior Associate, Regulatory Informatics
Department / CostCenter:
Pharmacovigilance – 219
Reports to (Job Title):
Associate Director, Regulatory Informatics
03 January 2019
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.
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.
Advanced understanding of regulations and guidances associated with submissions and their impact on Regulatory systems and Regulatory Information Management.
Able to answer some technical questions for many submission types.
Participate in team and sub-team meetings, volunteer for action items and participate in issue resolution.
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.
Quantify the scope or impact of the job in terms of revenue, expenses, capital investment, headcount, etc.
State both the minimum and the preferred educational attainment (or equivalent experience), and describe essential and desired subject matter, certifications, special training, etc.
Bachelor’s Degree desirable.
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.
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.
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
Describe the work environment characteristics that an employee encounters while performing the essential functions of the job.
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.
Describe any equipment required to perform the job.
List the key positions, internal and external, with which the job incumbent must interact.
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).
List the number of personnel directly reporting to this position and their job titles. List the number of personnel functionally reporting to this position (i.e., supervised on a “dotted-line” basis), and their job titles. Specify the total number of personnel supervised by this position, both directly and through others.
List the key accomplishments and skills that must be achieved to be eligible for promotion to the next position, if any, on the career ladder.