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Regulatory Operations Assistant - I
Ref No.: 18-38844
Location: Foster City, California
Position Type:Contract
Start Date / End Date: 07/30/2018 to 07/29/2019
Job Title: Regulatory Operations Assistant - I
Work Location: Foster City, CA
Length of the Assignment: 12 Months
Position Type: Contract Role
Client: A Big Pharmaceutical Company


Job Description:
The Disclosure &Transparency (D&T) function resides organizationally within Regulatory Documentation & Submissions (RDS) . The D&T function is responsible for clinical trial registrations and result postings in ClinicalTrials.gov (CTgov), EU Clinical Trial Register (EU-CTR), & European Union electronic Register of Post-Authorization Studies (EU Client Register/ENCePP). D&T 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.

Under close supervision, conducts Disclosures activities including:
• Registration of clinical trials on CTgov & ENCePP
• Results posting of clinical trial results on CTgov, EudraCT, and ENCePP
• Gains foundational understanding of industry regulations and guidances
• Disclosures processes and tools.
• Acquires basic knowledge of regulatory document timelines

JOB RESPONSIBILITIES AND SKILLS:
• Disclosures work is performed under the close supervision of more senior staff following detailed instructions with well-defined procedures.
• Registration of new clinical trials on CTgov & ENCePP
• Regular updates to protocol records on CTgov & ENCePP
• Results posting for clinical trials on CTgov, EU-CTR, & ENCePP
• Performs QC/editing of training manuals, business practices, checklist documents.
• Supports continual improvements by evaluating disclosure business process and providing suggestions to enhance compliance and efficiency.
• Has strong organization skills and attention to detail, along with ability to 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.
• Has well developed computer skills including proficiency in Word, Adobe and Excel.

TYPICAL EDUCATION & EXPERIENCE:

REQUIRED:
• 2+ 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)

NOT REQUIRED – BUT ADVANTAGEOUS:
• Disclosures experience (Clinical Trial Registration & Results Posting)

Interested candidates can share their most updated resume at wajid.khan@artech.com or they can reach out to me on #973-967-3412