Regulatory Operations AssistantIntegrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.Job DescriptionClinical Trail Disclosure & Transparency: The Disclosure &Transparency function resides organizationally within Medical WritingThe Disclosures function is responsible for clinical trial registrations and result postings in ClinicalTrials.gov and the EU Clinical Trial Register. Disclosures is also responsible for the EMA Policy 0070 (Publication of Clinical Data and Reports) activities. Project Involvement: Does not participate formally in cross functional teams, but may attend team meetings under direction of a more senior staff member. Key Contributions: Under close supervision, conducts Disclosures activities including:Registration of Clinical TrialsResults Posting of Clinical Trial Results and EudraCTExtraction of required documents for Policy 0070Redaction of documents for Policy 0070Gains foundational understanding of industry regulations and guidanceFDA and EMA Regulations regarding Registration of Clinical TrialsFDA & EMA Regulations regarding Results Posting of Clinical TrialsEMA Policy 0070 and associated RegulationsJob Responsibilities:Disclosures work is performed under the close supervision of more senior staff following detailed instructions with well-defined procedures.Registration of new Clinical TrialsRegular updates protocol RecordsResults Posting for Clinical Trials and EudraCTPolicy 0070 work is performed under the close supervision of more senior staff following detailed instructions with well-defined procedures.Collection, e-organization/e-filing, and tracking of Policy 0070 required documentsExtraction and preparation of Policy 0070 required documentsDraft Auto-Redaction and Manual Redaction of Policy 0070 documentsFacilitation of Policy 0070 review processFinalization and publication of Redacted documentsPreparation of other Policy 0070 materials (e.g. CCI Justification Tables, Anonymization Report, Cover Letter, Document Inventory, etc.)Performs QC/editing reviews of documents such as CSRs, IBs, CTDs, and other Clinical or Regulatory documents in line with internal document standards.Has strong organization skills and attention detail, along with ability work on a number of projects with tight timelines is required.Attends and participates in routine group meetings. May attend cross-functional meetings under the direction of a more senior staff meeting.Has excellent verbal and written communication skills and interpersonal skills.Qualifications2+ years of relevant experience and a BS degree.Clinical R&D experience (e.g. Clinical Operations)Basic understanding of Clinical Development and associated regulations (e.g. FDA, EMA) & best practices (e.g. ICH, GCP) Feel free to forward my email to your friends/colleagues who might be available. We do offer referral Bonus. Thank you.Kind Regards,Harris KaushikClinical RecruiterIntegrated Resources, Inc.IT Life Sciences Allied Healthcare CRODIRECT # - (650)-399-0891Gold Seal JCAHO Certified for Health Care Staffing"INC 5 0 0 0 's FASTEST GROWING, PRIVATELY HELD COMPANIES" (8th Year in a Row)