Job Title: Clinical Regulatory Writer, Associate Director / Manager

Location: Gaithesrburg, MD- Hybrid (3 days onsite)

Introduction to role:
Are you ready to be part of the solution, turning drug development strategies into reality? As an Associate Director in Clinical Regulatory Writing, you'll play a pivotal role in translating life-changing science into medicines. Our team provides expert communications leadership to drug projects, authoring strategically important clinical-regulatory documents that align with project strategies and regulatory requirements. We support AstraZeneca’s core therapeutic areas across all phases of clinical development, striving for excellence in communication to achieve successful submissions and approvals.

Accountabilities:

As a Clinical Regulatory Writer, Associate Director, you will:

• Independently manage clinical regulatory writing activities across a complex portfolio of work.

• Author the most complex clinical-regulatory documents within a program, ensuring regulatory, technical, and quality standards are met.

• Provide strategic communications leadership to projects, establishing communication standards and advocating for quality and efficiency.

• Drive the development of the clinical Submission Communication Strategy (cSCS) when acting as a submission lead.

• Lead internal/external authoring teams and partner with vendor medical writers to ensure timely and quality delivery.

• Interpret complex data and information, condensing it into clear, concise messages that meet customer information requirements.

• Demonstrate strategic thinking and review capabilities.

• Collaborate proactively with other functions at the program level.

• Support the development of Clinical Regulatory Writing Managers.

• Drive continuous improvement and operational excellence from a communications leadership perspective.
  Essential Skills/Experience:

• Education/Experience required:
  Associate Director level : BS Life Sciences degree or simiilar, 7+ yrs medical writing experience in pharmaceutical industry or CRO. Manager level: BS Life Sciences degree or simiilar, 2-7+ yrs medical writing experience in pharmaceutical industry or CRO

• Ability to advise and lead communication projects.

• Understand drug development and communication process from development, launch through life cycle management.

• In-depth knowledge of the technical and regulatory requirements related to the role.

• Ability to advise and lead communication projects.

• Understand drug development and communication process from development, launch through life cycle management.

• In-depth knowledge of the technical and regulatory requirements related to the role.
  

Desirable Skills/Experience:

• Advanced degree in a scientific discipline (Ph.D.)
  

This is a Hybrid role - minimum requirment 3 days per week onsite

The annual base pay (or hourly rate of compensation) for this position ranges from $133,042.40 - $199,563.60 USD Annual. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted

Closing Date