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Search for Jobs by Sheryl Horowitz

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Regulatory Operations Associate (Science & Biotech)
Philadelphia, PA 19103
Recruited by: Sheryl Horowitz | Owner | F-O-R-T-U-N-E Personnel Consultants, Inc. See all my Jobs

  • Hiring Company: F-O-R-T-U-N-E Personnel Consultants, Inc.
  • Industry: Science & Biotech
  • Compensation: Salary
  • Expires: Jun 22, 2019
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Job Description

Our client, a startup pharmaceutical company is currently hiring and expanding their team! This is an opportunity to join a growing team in a fast paced, exciting environment where you can grow your career along with the company! This position is located in Philadelphia, PA.

Regulatory Operations Associate

The Regulatory Operations Associate role will support the Clinical Trial Manager/Operational Team in executing the trial(s) and maintaining effective communication with project teams to ensure regulatory alignment with study timelines. May function as lead regulatory SSU associate.

Responsibilities
• Prepare standard documentation supporting regulatory filings and distribution to stakeholders.
• Utilize and maintain hard copy and electronic filing systems for auditable regulatory documents.
• Maintain effective high-profile communications and interactions with colleagues, collaborators, and clients as appropriate.
• Draft, edit, and distribute various documents as needed based on templates and work instructions.
• Develop and maintain work process tools to promote efficiency and productivity. These may include templates, SOPs, work instructions, checklists, etc.
• Track regulatory activity, maintain and update databases, and ensure that records are complete and current.
• Provide other administrative regulatory support as needed.
• Prepares Trial Master File according to SOPs.
• Reviews study related Trial Master File documentation to ensure compliance with SOPs and ICH-GCP on an ongoing basis, and before audit, inspection, or return of files to a Sponsor.
• Follows up study team or Sponsor requests for clarifications, supplementary information.
• Assists CTM with generation of study specific forms for Investigator Site Files.
• Attends Investigator and CRA meetings. Records questions and answers, and coordinates with the hotel staff to ensure smooth running of the meeting.
• Attends clinical teleconferences and prepares and distributes minutes for Sponsor and Project Teams within agreed timelines.
• Prepares Investigator Site Files, Investigator Manuals and Training Manuals.
• Manages returning/archiving study files.
• Generates and reviews management reports from internal tracking systems at requested intervals.
• Communicates with sites regarding trial start-up, conduct, and close-out activities at requested intervals, if needed.
• May participate in feasibility and/or site identification activities.
• Assists in resolution of logistical and practical issues on project and clinical trial administration processes.
EXPERIENCE
• Minimum of 1-2 years’ work experience.
• Must have excellent attention to detail; verbal and written communication skills.
• Superior organizational skills and customer service abilities are required.
• Experience publishing regulatory submissions using electronic submission software and proficiency in preparing documents that are compliant with electronic submission standards is preferred.
• Proficiency in MS Office (Word, Excel, and Outlook); experience with SharePoint is a plus.
• Must be able to exercise initiative and sound judgment, and to prioritize ongoing projects.
• Familiarity with Good Clinical Practices and/or experience of working in an FDA-regulated environment is desirable.
• General knowledge of the drug and vaccine development process or clinical trials is a plus.