Associate Director of Clinical Regulatory Writing

Associate Director of Clinical Regulatory Writing

Location: Gaithersburg, MD

Contract Details

• Position Type: Contract
• Contract Duration: 12 months
• Pay Rate: $75.00 $80.00 / Hour (USD)
• Shift / Schedule: 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 practices are applied.
• As part of a clinical delivery or submission team, provide strategic communications leadership to projects, establish communication standards and best practices, 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 a strong partnership with vendor medical writers to ensure delivery on time and 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.

Required Skills

• 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.

Education Requirements

• A Life Sciences master's degree in an appropriate discipline (required).
• Significant medical writing experience in the pharmaceutical industry or CRO (required).
• Advanced degree in a scientific discipline (Ph.D.) desirable.

Nice-to-Have Experience

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

Benefits

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

Important Notes

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

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: 26-06007 Industry: Healthcare

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