Clinical Regulatory Writer, Associate Director job opportunity at AstraZeneca.

Home Jobs In United States Of America Tag: Associate Director Clinical Regulatory Writer, Associate Director position at AstraZeneca


DatePosted 30+ Days Ago bot
AstraZeneca Clinical Regulatory Writer, Associate Director
Experience: General
Pattern: full-time
Country:
apply Apply Now
Salary:
Status:

Associate Director

Copy Link Report
degreeAssociate
loacation US - Boston - MA, United States Of America
loacation US - Boston - ..........United States Of America

Job Title: Clinical Regulatory Writer, Associate Director Location: Boston, MA - Hybrid Introduction to role: Are you ready 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. 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.   Accountabilities:   As a Clinical Regulatory Writer, Associate Director, you will: 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: BS Life Sciences degree in an appropriate discipline. Significant (7+ yrs) medical writing experience in the 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.)   This is a Hybrid role - minimum requirment 3 days per week onsite When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire 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.   AstraZeneca is where innovation meets collaboration. We harness diverse knowledge to move with agility, working seamlessly across functions globally. Our team is empowered to make quick decisions, influencing drug development strategy at all levels. With a science-driven approach, we bring life-changing medicines to patients, constantly asking questions and trying new things. Your professional growth is passionately supported here, with opportunities to work on projects at all stages of development.   Ready to make an impact? Apply now and be part of our dynamic team! The annual base pay (or hourly rate of compensation) for this position ranges from $133,042.40 - $199,563.60 USD Annual. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. Date Posted 28-Jan-2026 Closing Date 14-Feb-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

Other Ai Matches

Compliance Intern - Summer 2026 Applicants are expected to have a solid experience in handling Job related tasks
Senior Manager, Group Internal Audit Applicants are expected to have a solid experience in handling Group Internal Audit related tasks
Finance Business Partner Applicants are expected to have a solid experience in handling Job related tasks
Snr. Director – Head of Digital Diagnostics Applicants are expected to have a solid experience in handling Job related tasks
Level 3 Engineering Maintenance Technician Apprentice Applicants are expected to have a solid experience in handling Job related tasks
Chef de Produit Sénior Oncologie (H/F) Applicants are expected to have a solid experience in handling Job related tasks
Pharmaceutical Sales Specialist, CVRM Primary Care - Fort Myers, FL Applicants are expected to have a solid experience in handling CVRM Primary Care - Fort Myers, FL related tasks
Senior Pharmaceutical Sales Specialist, Respiratory Specialty Care -Kansas City, MO Applicants are expected to have a solid experience in handling Respiratory Specialty Care -Kansas City, MO related tasks
MR-BC-郑州 Applicants are expected to have a solid experience in handling Job related tasks
Account Business Manager Linea Lung Applicants are expected to have a solid experience in handling Job related tasks
合作营销经理-Eagle-汉中 Applicants are expected to have a solid experience in handling Job related tasks
Clinical Research Associate, Oncology Applicants are expected to have a solid experience in handling Oncology related tasks
Biologics Engineering: Protein Engineering & Novel Modalities Intern Applicants are expected to have a solid experience in handling Job related tasks
Content Delivery Manager (CDM) CEEBA - GCS - Content & Omnichannel Applicants are expected to have a solid experience in handling Job related tasks
Associate Principal Scientist, Process Engineering – Global Product Development Applicants are expected to have a solid experience in handling Process Engineering – Global Product Development related tasks
Senior Scientist Integrated Bioanalysis – Immunoassay Specialist Applicants are expected to have a solid experience in handling Job related tasks
Regional Liaison Director – Immunology Field Medical Northeast Applicants are expected to have a solid experience in handling Job related tasks
Directeur Régional CVRM - Bretagne (H/F) Applicants are expected to have a solid experience in handling Job related tasks
Clinical Regulatory Writer, Associate Director Applicants are expected to have a solid experience in handling Associate Director related tasks
MR-BC-成都 Applicants are expected to have a solid experience in handling Job related tasks
Senior Scientist – Oncology Targeted Discovery (Drug Conjugates) Applicants are expected to have a solid experience in handling Job related tasks
ADC Sr. Brand Manager Applicants are expected to have a solid experience in handling Job related tasks
SMM/AD-CVRM MKT-上海 Applicants are expected to have a solid experience in handling Job related tasks