Regulatory Operations Assistant

Clinical Trail Disclosure & Transparency:
The Disclosure &Transparency function resides organizationally within Medical Writing

The 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 Trials o
Results Posting of Clinical Trial Results and EudraCT
Extraction of required documents for Policy 0070
Redaction of documents for Policy 0070

Gains foundational understanding of industry regulations and guidance
FDA and EMA Regulations regarding Registration of Clinical Trials
FDA & EMA Regulations regarding Results Posting of Clinical Trials
EMA Policy 0070 and associated Regulations

Job Responsibilities:

• Disclosures work is performed under the close supervision of more senior staff following detailed instructions with well-defined procedures.

• Registration of new Clinical Trials

• Regular updates protocol Records

• Results Posting for Clinical Trials and EudraCT

• Policy 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 documents

• Extraction and preparation of Policy 0070 required documents

• Draft Auto-Redaction and Manual Redaction of Policy 0070 documents

• Facilitation of Policy 0070 review process

• Finalization and publication of Redacted documents

• Preparation 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.