Clinical Regulatory Writing Lead — Associate Director

AstraZeneca GmbH; Boston (MA); Hybrid; USD 133,000 - 200,000; Full time

Job summary

AstraZeneca is seeking an Associate Director / Manager Clinical Regulatory Writer in Boston, MA or Gaithersburg, MD (hybrid, 3 days onsite). You will lead complex clinical-regulatory writing across a portfolio, ensuring regulatory and quality standards and shaping the Submission Communication Strategy.

Ideal candidates have 7+ years of medical writing experience or 2-7+ for manager level, and a Life Sciences degree.

Qualifications

• Education/Experience: Associate Director level requires BS Life Sciences or equivalent with 7+ years medical writing experience; Manager level requires BS Life Sciences with 2-7+ years medical writing experience.

Responsibilities

• Independently manage clinical regulatory writing activities across a complex portfolio.
• Author the most complex clinical-regulatory documents ensuring regulatory, technical and quality standards.
• Provide strategic communications leadership and establish communication standards.
• Drive the development of the clinical Submission Communication Strategy (cSCS) as submission lead.
• Lead internal/external authoring teams and collaborate with vendor medical writers for timely, quality delivery.
• Interpret complex data into clear messages meeting customer information requirements.
• Demonstrate strategic thinking and review capabilities; collaborate across functions at program level.
• Support development of Clinical Regulatory Writing Managers and drive continuous improvement.

Skills

Strategic leadership

Regulatory writing

Cross-functional collaboration

Project management

Education

BS Life Sciences

PhD preferred

Job description

AstraZeneca is seeking an Associate Director / Manager Clinical Regulatory Writer in Boston, MA or Gaithersburg, MD (hybrid, 3 days onsite). You will lead complex clinical-regulatory writing across a portfolio, ensuring regulatory and quality standards and shaping the Submission Communication Strategy.

Ideal candidates have 7+ years of medical writing experience or 2-7+ for manager level, and a Life Sciences degree.