Medical Writer - Quality Control Lead

Company Overview

(Company information is not specified.)

Job Summary

The Medical Writer - Quality Control Lead will play a crucial role in ensuring the quality and accuracy of clinical documents within the pharmaceutical or Clinical Research Organization (CRO) environment. This position is responsible for leading quality control initiatives, ensuring compliance with regulatory guidelines, and maintaining high standards in medical writing. The role contributes significantly to the successful development and submission of clinical documents, thereby supporting the organization’s overall goals.

Responsibilities

• Lead the development and quality control of clinical documents including Clinical Study Reports (CSR), Investigator Brochures (IB), protocols, Informed Consent Forms (ICFs), Risk Management Plans (RMPs), and regulatory submissions.
• Manage the quality assurance processes pertaining to medical writing to ensure compliance with industry standards and regulatory requirements.
• Collaborate with cross-functional teams to ensure alignment and clarity of documentation and regulatory submissions.
• Stay updated on regulatory guidelines, industry trends, and emerging technologies, applying this knowledge to enhance the efficiency and effectiveness of medical writing practices.
• Provide training and mentorship to junior medical writers and contribute to their professional development.

Qualifications

• Education: Master’s degree or higher in Life Sciences, Pharmacy, or Biomedical Sciences.
• Experience:
  • A minimum of 8-12 years in Medical Writing and Quality Control within a pharmaceutical or CRO environment.
  • At least 3-5 years in a process, quality, or technical leadership role.
• Technical Skills:
  • Proven expertise in preparing clinical documents (CSR, IB, protocols, ICFs, RMPs, and regulatory submissions).
  • Strong understanding of regulatory guidelines (such as ICH E3, E6, GPP, EMA, FDA).
• Soft Skills:
  • Excellent communication skills, strategic thinking, and stakeholder management abilities.
  • Ability to manage multiple projects and priorities effectively.

Preferred Skills

• Knowledge of emerging technologies and industry trends to drive innovation in medical writing practice.

Experience

• 8-12 years of relevant experience in Medical Writing and Quality Control, including significant leadership experience.

Environment

(Work setting, location, and physical/environmental conditions are not specified.)

Salary

(Salary information is not specified.)

Growth Opportunities

(Career advancement opportunities within the company are not specified.)

Benefits

(Benefits offered are not specified.)