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Regulatory Information Analyst

T

The Fountain Group

Regulatory Information Analyst

Cambridge, MA
Full Time
Paid
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  • Responsibilities

    Job Description

    JOB DESCRIPTION

    • Remote at first, onsite later; candidate must be able to commute or relocate to Cambridge, MA.
    • Qualified candidates have Regulatory experience, RIM or Submission/eCTD publishing experience, and knowledge of regulatory submissions; experience with Veeva Vault, RIM, eCTD, MedDRA, MS Word/Excel/PowerPoint, Pharmaceuticals, and EU submissions is preferred, not required.
    • Supports the Global Regulatory Operations Informatics and Analytics group with oversight of Regulatory Information management; acts to secure the integrity of data that is used internally for business intelligence/reporting purposes and externally to comply with GRA information requests/obligations.
    • Ensures the maintenance and alignment of system dictionaries or code lists to the appropriate company/ industry/agency standards.
    • Enters data into the company’s Regulatory Information System(s) and where appropriate performs data verification on behalf of data owners.
    • Carries out remediation activities for known data quality issues upon directive from management.
    • Establishes and maintains regular contact with information providers, verifiers, and key stakeholders.
    • Responsible for identifying internal process issues/risks/ deficiencies to senior information specialist.
    • Identifies, logs, and tracks issues raised by information providers and team members through to resolution. Where appropriate, responds to information provider requests independently and collaborates with IT to help identify and implement optimal solutions.
    • Performs quality checks of submission of data and supporting documentation submitted to external agency databases such as XEVMPD to ensure compliance with agency requirements.
    • Identifies, tracks, and remediates to complete remediation activities on data quality issues.
    • Formally gathers compliance metrics and detail from vendor and reports back to Information and Analytics team
    • Accountable for providing business analysis and support for key projects; also accountable for interface with key vendors business stakeholders.

    If you are interested in hearing more about the position, PLEASE RESPOND TO THIS POSTING WITH YOUR RESUME ATTACHED AND CONTACT INFORMATION INCLUDED.

    You may also forward this posting to any qualified friends or colleagues as we do offer a REFERRAL BONUS for any candidate who is hired and still gainfully employed after 30 days.

    Company Description

    Looking for a new career, or a change from your current work environment? The Fountain Group gives you access to more opportunities in your area of expertise and allows you to gain advice and skills training that will help you advance in your chosen career field