Associate Director Clinical Regulatory Writing Gaithersburg, Maryland

Location Gaithersburg, Maryland, United States

Job ID R-232971

Date posted 04/08/2025

Introduction to role

Are you ready to lead the charge in strategic communication excellence? As part of the Clinical Regulatory Writing team, you'll be at the forefront of crafting pivotal clinical-regulatory documents that align with project strategies and regulatory requirements. Our mission is to support core therapeutic areas throughout all phases of clinical development, ensuring successful submissions and approvals. Join us in driving communication leadership and making a tangible impact on drug projects!

Accountabilities

• Independently manage clinical regulatory writing activities across a portfolio of work.
• Author clinical-regulatory documents within a program, ensuring adherence to regulatory, technical, and quality standards.
• 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 collaborate with vendor medical writers to ensure timely and quality delivery.
• Interpret complex data and information, condensing it into clear, concise, and accurate 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 others in Clinical Regulatory Writing.
• Drive continuous improvement and operational excellence from a communications leadership perspective.

Essential Skills/Experience

• Masters degree in Science.
• 2-4 years of active experience medical writing experience in the pharmaceutical industry or CRO.
• Medical writing experience to include:
  • IND (Briefing documents, Clinical study protocols, Paediatric investigational plans, Phase 1 and 2/3 CSR)
  • NDA (Phase 3 CSR, Module 2 Summaries)

• 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).
• NDA (Phase 3 CSR, Module 2 Summaries)
• Health authority response (HAQ)

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we are driven by our passion for science and our commitment to making a difference. Our dynamic environment encourages creativity and innovation, allowing us to explore without limits. We are dedicated to treating, preventing, modifying, and even curing some of the world's most complex diseases. By fusing data and technology with scientific innovations, we aim to achieve breakthroughs that redefine what's possible. Join us in our mission to positively impact the lives of billions of patients worldwide.

Ready to make an impact? Apply now and be part of a team that pushes the boundaries of science!

The annual base pay (or hourly rate of compensation) for this position ranges from $133,042 to $199,563. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.