Associate Director - CRO

the Client•Gaithersburg, MD

1d•Onsite

About The Position

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. The team supports the company's core therapeutic areas in all phases of clinical development. The vision is to be an industry-leading organization driving strategic communication excellence to achieve successful submissions and approvals.

Requirements

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 and launch through life cycle management
In-depth knowledge of the technical and regulatory requirements related to the role

Nice To Haves

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

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.
Be proactively collaborative 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.