Clinical Regulatory Writing Associate Director

Zenith LifeScience; Gaithersburg (MD); On-site; USD 150,000 - 210,000; Full time

Job summary

Zenith LifeScience in Gaithersburg, MD seeks an experiencedClinical Regulatory Writing Associate Director to lead regulatory writing across a complex program portfolio. You will author the most intricate clinical-regulatory documents and ensure regulatory, technical, and quality standards are met, while driving strategic communications and vendor collaboration.

The role requires leading submission strategies (cSCS), mentoring teams, translating complex data into concise regulatory messages, and

Qualifications

• Master's degree in Life Sciences.
• 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 through lifecycle.
• In depth knowledge of regulatory requirements related to the role.
• Desirable: Advanced degree (Ph.D.).

Responsibilities

• Independently manage clinical regulatory writing activities across a complex portfolio.
• Author the most complex clinical-regulatory documents within a program ensuring regulatory, technical and quality standards.
• Provide strategic communications leadership to projects and establish standards and best practices.
• Drive development of the clinical Submission Communication Strategy (cSCS) when acting as submission lead.
• Lead internal/external authoring teams and coordinate with vendor medical writers for timely delivery.
• Translate complex data into clear regulatory messages addressing customer information needs.
• Act as a strategic thinker with strong review capabilities and cross-functional collaboration.
• Support development of Clinical Regulatory Writing Managers and drive continuous improvement.

Skills

Regulatory writing

Clinical study protocols

CSRs / CSPs / IBs

Team leadership

Submission strategy (cSCS)

Vendor management

Strategic communications

Education

Life Sciences Master's degree

Ph.D. desirable

Job description

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.)