.We are now recruiting a Senior Director Clinical Regulatory Writing (CReW) to lead the Late Respiratory and Immunology (Late R&I; ) CReW teams. The role can be placed in and will report into the Executive Director, Late R&I; . Our Organization follows a hybrid work structure where employees are required to be onsite 3 days a week.Location : Gaithersburg, Waltham, Gothenburg, Bangalore, and Barcelona.The Clinical Regulatory Writing teams provide 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.CReW supports the Company's core therapeutic areas in all phases of clinical development. The vision is to be an industry-leading organization driving crucial communication excellence to achieve successful submissions and approvals.The Senior Director Clinical Regulatory Writing Head will be overall accountable for the provision of expert clinical regulatory writing leadership for programs and activities within Early and Late for the respective TA. In addition, this role will shape the respective TA-specific Clinical Regulatory Writing group by providing strategic direction based on current and future needs, building internal capability, developing and managing vendor relationships, driving digitalisation initiatives, and encouraging collaborations with team members and functional counterparts.You are a proactive leader who understands the imperatives of the respective TA and acts accordingly with a sense of urgency and innovative thinking. In this role you will act as a line manager, being advocates for your team and creating an engaged and productive environment to thrive.Accountabilities will include: Overall accountable for the provision of expert clinical regulatory writing leadership for programs and activities within Early and Late programs within the respective TA.Ensure thorough engagement with the cross-TA CReW leadership team, the allocation of resources that aligns with strategic prioritization of the respective TAs.Be a leader within the disease area or drug programs. Actively collaborate with TA strategy leaders to translate portfolio/product direction (e.G. drug programs with multiple indications/combinations) into a strategic vision (i.E. Submission Communication Strategy) for the CReW team.Set clear direction while advising others and develop innovative solutions in highly complex situations.Determine and establish group structure in consultation with other TA CReW Heads to meet the business needs of Clinical Regulatory Writing.Coach, mentor, develop and lead therapeutically aligned staff and identify skill development opportunities for direct reports, together with appropriate succession planning.Manage budget and productivity targets/metrics for therapeutically aligned staff and programs