Regulatory Medical Writer Lead Position

1 week ago


Carlsbad, United States Lifelancer Full time

Job Overview

At Lifelancer, we are seeking a skilled Regulatory Medical Writer to join our team. As a key member of our regulatory writing department, you will play a crucial role in preparing and managing clinical regulatory documents for submission to regulatory agencies.

About the Company

Lifelancer is a leading talent-hiring platform connecting professionals with opportunities in life sciences, pharma, health sciences, healthtech, and IT domains. Our goal is to facilitate growth and development within these industries by matching talented individuals with suitable job openings.

Key Responsibilities

  • Collaborate with internal teams to lead, write, and manage complex clinical regulatory documents, including clinical study reports, Investigator Brochures, clinical study protocols, briefing documents, and marketing application summary documents.
  • Develop and maintain subject matter expertise within the department for assigned therapeutic/product areas.
  • Plan and lead cross-functional teams to meet timelines for deliverables, ensuring adherence to regulatory requirements and guidelines.
  • Conduct data interpretation meetings, comment resolution meetings, and other document-related meetings as needed.
  • Perform quality control reviews, interact with Quality Assurance to resolve audit findings, and ensure compliance with relevant regulations and guidelines.

Requirements

  • Bachelor's degree required, advanced degree in a relevant scientific/clinical/regulatory field preferred.
  • A minimum of 8 years of direct experience as a medical writer preparing regulated documents in the pharmaceutical industry, with experience as lead writer of key documents included in major US and/or international regulatory submissions.
  • Extensive working knowledge of FDA, EMA, and ICH guidelines, particularly ICH E3 and ICH E6.
  • Experience mentoring junior writers and ability to assimilate and analytically interpret scientific data.

Estimated Salary

$126,339 - $160,340 per year.

Benefits

We offer an excellent benefits package, which includes comprehensive health insurance, retirement savings plan, paid time off, and opportunities for professional growth and development.



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