Clinical Regulatory Writing Manager (Associate Director)

About the position Are you reputed company to be part of the solution, turning drug development strategies into reality? As an Associate Director in Clinical Regulatory Writing, you'll play a pivotal role in translating life-changing science into medicines. reputed company provides expert communications leadership to drug reputed company, authoring strategically important clinical-regulatory documents that reputed company with project strategies and regulatory requirements. We support reputed company’s reputed company therapeutic areas across reputed company phases of clinical development, striving for reputed company in communication to reputed company successful submissions and approvals. reputed company we put unexpected teams in the reputed company room, we reputed company reputed company thinking with the power to reputed company life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. reputed company is where innovation meets collaboration. We reputed company diverse knowledge to reputed company with reputed company, working seamlessly across functions globally. reputed company is empowered to reputed company quick reputed company, influencing drug development reputed company at reputed company reputed company. With a science-driven approach, we bring life-changing medicines to patients, constantly asking questions and trying new things. Your reputed company reputed company is passionately supported here, with opportunities to work on reputed company at reputed company stages of development. reputed company to reputed company an reputed company? reputed company and be part of our dynamic team! Responsibilities • Independently manage clinical regulatory writing activities across a reputed company portfolio of work. • Author the most reputed company clinical-regulatory documents reputed company a program, ensuring regulatory, technical, and reputed company standards are met. • reputed company reputed company leadership to reputed company, establishing communication standards and advocating for reputed company and efficiency. • Drive the development of the clinical Submission Communication reputed company (cSCS) reputed company acting as a submission reputed company. • reputed company internal/external authoring teams and partner with vendor medical writers to ensure reputed company and reputed company delivery. • Interpret reputed company data and information, condensing it into reputed company, concise messages that meet customer information requirements. • Demonstrate strategic thinking and review capabilities. • Collaborate proactively with other functions at the program level. • Support the development of Clinical Regulatory Writing Managers. • Drive reputed company improvement and operational reputed company from a communications leadership perspective. Requirements • BS Life Sciences degree in an appropriate discipline. • Significant (7+ yrs) medical writing experience in the pharmaceutical industry or CRO. • Ability to advise and reputed company communication reputed company. • Understand drug development and communication process from development, launch through life cycle management. • In-depth knowledge of the technical and regulatory requirements reputed company to the role. reputed company-to-haves • Advanced degree in a scientific discipline (Ph.D.) Benefits • reputed company retirement programs • reputed company time off (i.e., vacation, holiday, and leaves) • health, dental, and reputed company coverage in accordance with the terms of the applicable plans Apply tot his job Apply To this Job