Director of Regulatory Medical Writing and Strategy

7 days ago


Lexington, Kentucky, United States AL Solutions Full time
Job Overview

AL Solutions is seeking a highly motivated Director of Regulatory Medical Writing for a major Biotech company specializing in Oncology.

Key Responsibilities
  • Leadership and Team Management
    • Lead a team of regulatory writers, providing guidance and mentorship to enhance their skills and ensure high-quality output.
    • Develop and implement a regulatory writing strategy that aligns with the company's goals and objectives.
  • Regulatory Writing and Compliance
    • Oversee the development of critical documents, including Clinical Study Reports (CSRs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
    • Ensure compliance with health authority guidelines and regulations.
  • Cross-Functional Collaboration
    • Collaborate with cross-functional teams, including clinical, safety, and medical affairs, to produce high-quality documents.
    • Communicate effectively with regulatory agencies during submissions and interactions.
  • Process Improvement
    • Drive initiatives to optimize processes and improve the efficiency of the regulatory writing function.
    • Identify areas for improvement and implement changes to enhance productivity and quality.
Requirements
  • Education and Experience
    • Advanced degree in Life Sciences, Medicine, or related field (PhD, MD preferred).
    • 8+ years of regulatory medical writing experience, with a focus on oncology.
  • Leadership and Communication Skills
    • Proven leadership experience in managing teams and projects in a fast-paced environment.
    • Excellent communication skills, with the ability to convey complex information clearly and persuasively.
  • Organizational and Technical Skills
    • Strong organizational skills, with a keen eye for detail and the ability to manage multiple priorities effectively.
    • In-depth understanding of regulatory requirements for drug development, particularly in oncology.
What We Offer
  • Competitive Compensation and Benefits
    • Very competitive Basic Salary
    • Up to 22% annual performance bonus
    • Stocks options and LTI programs
    • Home office Allowance
    • Annual company offsite holiday
    • Mental health awareness - 8 company-paid therapy sessions a year
    • Sports Club & Gym membership
    • 100% paid medical insurance
    • 401(k) program


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