External Communications Associate Director - Clinical Regulatory

External Comms Associate Director - Clinical Regulatory

Location: Gaithersburg, MD

Onsite Flexibility: Onsite

Contract Details

• Position Type: Contract
• Contract Duration: 9 months
• Pay Rate: $65.00 $75.00 / Hour (USD)
• Shift / Schedule: Day Working Hours: 8 AM 4 PM or 9 AM 5 PM
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Job Summary

The Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important clinical-regulatory documents that are label-focused and align with project strategies, regulatory requirements, and communications best practices. We support the Company's core therapeutic areas in all phases of clinical development. Our vision is to be an industry-leading organization driving strategic communication excellence to achieve successful submissions and approvals.

Key Responsibilities

• Independently manage clinical regulatory writing activities across a complex portfolio of work.
• Author the most complex clinical-regulatory documents within a program by ensuring that relevant regulatory, technical and quality standards are achieved, and that relevant processes and best practice are applied.
• As part of a clinical delivery or submission team, provide strategic communications leadership to projects, establish communication standards and best practice, and continuously advocate for quality and efficiency.
• When acting as a submission lead, drive the development of the clinical Submission Communication Strategy (cSCS).
• Lead internal/external authoring teams and provide strong partnership with vendor medical writers to ensure delivery on time and to quality.
• Drive the clinical interpretation of complex data and information and condense it into clear, concise, and accurate messages that address customer information requirements.
• Be a strategic thinker and demonstrate strategic review capabilities.
• Proactively collaborate 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, including representing the skill on drug and non-drug projects, as required.

Education Requirements

• Life Sciences master's degree in an appropriate discipline (required).
• Advanced degree in a scientific discipline (Ph.D.) (desirable).

Required Experience

• Significant medical writing experience in the pharmaceutical industry or CRO.
• Ability to advise and lead communication projects.
• Understanding of 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.

Benefits

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund

Important Notes

• Interview Process: First Round 30 minutes via Teams.
• Second Round: Panel 2 hours via Teams.

About the Client

This global biopharmaceutical company is driven by a defining mission to push the boundaries of science and deliver life-changing medicines that transform the lives of patients worldwide. With a footprint spanning more than 100 countries, the organization focuses on oncology, cardiovascular and metabolic disease, and respiratory and immunology, while also advancing treatments in rare diseases and vaccines and employs tens of thousands of scientists, clinicians, and business professionals globally. In 2026, employees voted this organization onto Glassdoor's Best Places to Work list, where it holds a 4.0-star overall rating from nearly 8,000 reviews, with 79% of employees saying they would recommend working here to a friend. Teams span oncology researchers, clinical trial specialists, regulatory scientists, and commercial and market access professionals.

About GTT

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.

Job Number: 26-11494 Industry: Healthcare

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