Clinical Regulatory Writing Associate Director

Posted 2 days ago

zenith lifescienceGaithersburg (MD)

Regulatory Affairs Managers Research and Development in Biotechnology (except Nanobiotechnology)

SENIORITY

Manager

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About the role

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. The Clinical Regulatory Writing Associate Director is expected to: 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 to 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 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 Education, Qualifications, Skills and Experience Life Sciences Master's degree in an appropriate discipline Significant medical writing experience in the 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 Desirable: Advanced degree in a scientific discipline (Ph. D.).

Key Skills & Experience: (Must have): Regulatory writing Clinical Study Protocols Clinical Study Reports (CSRs)Medical/Clinical Authoring experience including CSRs, CSPs, IBs(Direct, hands-on authoring experience in strategic and clinical regulatory documents, including briefing books, clinical overviews, clinical summaries, clinical study reports, clinical study protocols, and investigator brochures and have also led major clinical submissions, such as MAA, IND, and NDA.)

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