Clinical Regulatory Writer (Associate Director or Manager)

Job Title: Clinical Regulatory Writer, Associate Director or Manager Location: Boston, MA - Hybrid (3 days onsite) Are you ready to be part of the solution, turning drug development strategies into reality? As a Clinical Regulatory Writer, you will play a pivotal role in translating life‑changing science into medicines. Our team provides expert communications leadership to drug projects, authoring strategically important clinical‑regulatory documents that align with project strategies and regulatory requirements. We support AstraZeneca’s core therapeutic areas across all phases of clinical development, striving for excellence in communication to achieve successful submissions and approvals. This is a Hybrid role - minimum requirement 3 days per week onsite. Responsibilities Independently manage clinical regulatory writing activities across a complex portfolio of work. Author the most complex clinical‑regulatory documents within a program, ensuring regulatory, technical, and quality standards are met. Provide strategic communications leadership to projects, establishing communication standards and advocating for quality and efficiency. Drive the development of the clinical Submission Communication Strategy (cSCS) when acting as a submission lead. Lead internal/external authoring teams and partner with vendor medical writers to ensure timely and quality delivery. Interpret complex data and information, condensing it into clear, 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 continuous improvement and operational excellence from a communications leadership perspective. Essential Skills & Experience Education/Experience required: Associate Director level – BS Life Sciences degree or similar, 7+ years medical writing experience in pharmaceutical industry or CRO. Education/Experience required: Manager level – BS Life Sciences degree or similar, 2–7+ years medical writing experience in 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 Skills & Experience Advanced degree in a scientific discipline (Ph.D.). Experience with CSR, CTD module 2 summaries. Experience leading clinical submission (NDA/BLA/MAA). Experience developing clinical submission communication strategy. Compensation & Benefits The annual base pay for Associate Director level ranges from $133,042.40 to $199,563.60 USD. For Manager level, ranges from $113,293.60 to $169,940.40 USD. Positions offer eligibility for various incentives, including short‑term incentive bonuses, equity‑based awards for salaried roles, and commissions for sales roles. Benefits include qualified retirement programs, paid time off (vacation, holiday, and leaves), and health, dental, and vision coverage. EEO Statement Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. We welcome and consider applications from all qualified candidates, regardless of protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. #J-18808-Ljbffr AstraZeneca