Regulatory and Site Start Up Specialist

5 hours, 55 minutes ago
Full-time
Junior
Project and Program Management
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised

Description

  • Coordinate timely, high-quality site activation readiness and identify and mitigate activation risks.
  • Prepare clinical trial applications and submission dossiers for Competent Authorities, Ethics Committees, and other local bodies.
  • Interact with regulatory authorities and ethics committees and manage responses.
  • Track submission status and provide updates to study leadership and project teams.
  • Maintain project plans, trackers, regulatory intelligence tools, and site activation critical paths.
  • Develop or support study-specific start-up plans, IMP release requirements, and essential document review criteria.
  • Coordinate with CRAs and cross-functional teams to collect essential documents and secure site activation and IMP release.
  • Customize patient information sheets and informed consent forms and coordinate document translations.
  • Support feasibility activities, pre-study site visits, budget negotiations, and investigator contract execution when required.
  • Maintain knowledge of applicable regulations, audit and inspection readiness, and required TMF filing standards.

Requirements

  • Bachelor’s degree in life sciences or a related scientific or healthcare field, RN qualification, or equivalent education, training, and experience.
  • At least 1 year of experience as a Regulatory or Start-Up Specialist, or in a comparable CRO, pharmaceutical, or biotechnology role.
  • Relevant experience with feasibility, contract negotiations, and Competent Authority, Ethics Committee, or IRB submissions preferred.
  • Strong communication, organizational, prioritization, and deadline-management skills.
  • Experience with computerized information systems, electronic spreadsheets, word processing, and email.
  • Fluency in English.
  • Experience with milestone tracking tools or systems preferred.
  • Pharmacy qualification or pharmacist work experience preferred.
  • Advanced degree such as MD, PhD, PharmD, or master’s in regulatory science, or RAC certification preferred.

Benefits

  • Opportunities to contribute to clinical research involving innovative cancer therapies.
  • Employee input and ideas are valued and supported.
  • Equal opportunity employer.
  • Reasonable accommodations available throughout the application process.

Interested in this position?

Apply directly on the company website

Apply Now

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