Associate Director, Clinical Regulatory Writing (CReW)

Are you passionate about Regulatory Writing? Would you like to have an impact on patients’ lives and contribute to eliminate cancer as a cause of death? If so then join us! Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration. The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you’ll find newly-designed, activity-based work spaces to suit a variety of working styles while increasing collaboration between teams. We are now recruiting an **Associate Director, Clinical Regulatory Writing (CReW).** 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 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 portfolio of work. - Author 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 others in Clinical Regulatory Writing. - Drive continuous improvement and operational excellence from a communications leadership perspective, including representing the skill on drug and non-drug projects, as required. **Minimum Qualifications:** - Bachelor's degree in Life Sciences in an appropriate subject area - Minimum of 5 years’ experience - Significant medical writing experience in the pharmaceutical industry or CRO. - Ability to advise and lead communication projects. - Understand drug development and communication process…