Associate Director, Clinical Regulatory Writing

Location: Gaithersburg, MD

Duration: 12 months

Pay: $75.00 per hour

Typical Accountabilities

:
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 approval

s.
The Clinical Regulatory Writing Associate Director is expected

to:• Independently manage clinical regulatory writing activities across a complex portfolio of wo

rk.• 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 appli

ed.• 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 efficien

cy.• When acting as a submission lead, drive the development of the clinical Submission Communication Strategy (cSC

S).• Lead internal/external authoring teams and provide strong partnership with vendor medical writers to ensure delivery to time and quali

ty.• Drive the clinical interpretation of complex data and information and condense it into clear, concise and accurate messages that address customer information requiremen

ts.• Be a strategic thinker and demonstrate strategic review capabiliti

es.• Proactively collaborative with other functions at the program lev

el.• Support the development of Clinical Regulatory Writing Manage

rs.• Drive continuous improvement and operational excellence from a communications leadership perspective, including representing the skill on drug and non-drug projects, as requi

red
Education, Qualifications, Skills and Experie

nce:
Essen

tial:• Life Sciences degree in an appropriate discip

line.• Significant medical writing experience in the pharmaceutical industry or

CRO.• Ability to advise and lead communication proj

ects.• Understand drug development and communication process from development, launch through life cycle manage

ment.• In depth knowledge of the technical and regulatory requirements related to the

role• Master's or advanced degree in a scientific discipline (P