Job Title: Regulatory Operations Assistant
Location: Foster City, CA
Job Type: Contract
Company Overview:
Integrated Resources, Inc. (IRI) has been a trusted provider of strategic workforce solutions since 1996. Led by a seasoned team with decades of industry experience, IRI has built a reputation for delivering expert talent in IT, Life Sciences, and Healthcare. Our commitment to excellence has enabled us to grow steadily and expand across new sectors.
Job Description:
The Regulatory Operations Assistant will work within the Medical Writing division, specifically supporting the Clinical Trial Disclosure & Transparency function. This role involves assisting with clinical trial registrations, results postings, and activities related to EMA Policy 0070. Tasks are performed under the close supervision of senior staff and follow well-defined procedures.
Key Responsibilities:
Conduct disclosure activities under supervision:
Register new clinical trials.
Update protocol records regularly.
Post results for Clinical Trials and EudraCT.
Assist with Policy 0070 documentation:
Collect, organize, file, and track required documents.
Extract and prepare documents for submission.
Perform both auto- and manual redactions.
Facilitate internal review processes.
Finalize and publish redacted documents.
Prepare supplemental Policy 0070 materials, including:
CCI Justification Tables
Anonymization Reports
Cover Letters
Document Inventories
Perform QC/editing of various documents such as:
Clinical Study Reports (CSRs)
Investigator Brochures (IBs)
Common Technical Documents (CTDs)
Other Clinical/Regulatory documentation
Attend and contribute to group meetings; may attend cross-functional meetings as needed.
Manage multiple projects under tight timelines with high attention to detail.
Qualifications:
Bachelor’s degree with 2+ years of relevant experience.
Experience in Clinical R&D (e.g., Clinical Operations).
Foundational understanding of:
FDA and EMA regulations.
Clinical trial registration and results posting requirements.
EMA Policy 0070 guidelines.
ICH-GCP best practices.
Excellent organizational, verbal, and written communication skills.
Strong attention to detail and ability to follow precise instructions.
Referral Note:
Candidates are encouraged to share this opportunity with friends or colleagues. Referral bonuses are available.
Contact Information:
Harris Kaushik
Clinical Recruiter – Integrated Resources, Inc.
Direct: (650) 399-0891
Gold Seal JCAHO Certified ™
INC 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES (8th Year in a Row)
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