About Company
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. With a strong commitment to pushing the boundaries of science, we aim to deliver life-changing medicines that make a meaningful difference to patients worldwide. Our innovative spirit and collaborative culture drive us to continually explore new frontiers in healthcare, transforming challenging diseases into treatable conditions. We foster an environment where scientific rigor meets patient-centric innovation, empowering our teams to make bold decisions and pursue ambitious goals that redefine medical possibilities.
Job Description
Are you a meticulous wordsmith with a passion for science and a deep understanding of clinical research? AstraZeneca is seeking a talented and experienced Medical Writer to join our dynamic team, contributing to groundbreaking advancements in healthcare from our hybrid base near Mizner Park, Boca Raton. In this pivotal role, you will be instrumental in translating complex scientific data into clear, concise, and compelling narratives for a diverse range of regulatory, clinical, and scientific documents. You will have the unique opportunity to contribute significantly to the development and communication of groundbreaking medicines across our therapeutic areas, ultimately impacting patient lives globally.
This position demands a strong grasp of medical terminology, an analytical ability to interpret and critically evaluate clinical data, and exceptional writing and communication skills. You will not only author documents but also play a critical role in shaping the scientific story of our innovative therapies. You will work within a highly collaborative and cross-functional environment, engaging with various stakeholders including clinical development scientists, regulatory affairs specialists, biostatisticians, and medical affairs professionals. Your expertise will be crucial in ensuring that all documentation, from early-phase protocols to comprehensive clinical study reports and summary documents for regulatory submission, meets the highest standards of scientific accuracy, regulatory compliance (including ICH, FDA, EMA guidelines), and ethical principles.
We are looking for an individual who thrives in a fast-paced, intellectually stimulating environment, possesses superior attention to detail, and can manage multiple complex writing projects simultaneously while consistently adhering to aggressive timelines and stringent quality standards. This role is ideal for a proactive, self-motivated professional dedicated to scientific excellence, accuracy, and patient-centric outcomes. If you are passionate about the power of science to change lives and are eager to contribute your expertise to a world-leading biopharmaceutical company, join us and be a part of AstraZeneca’s mission to push the boundaries of science and deliver life-changing medicines.
Key Responsibilities
- Prepare, write, and edit a variety of clinical and regulatory documents (e.g., Clinical Study Reports, protocols, Investigator Brochures, informed consent forms, patient narratives, scientific publications).
- Synthesize and interpret complex clinical data from various sources, ensuring accuracy, consistency, and adherence to scientific principles across all documents.
- Collaborate effectively with cross-functional teams, including clinical development, regulatory affairs, biostatistics, and medical affairs, to gather necessary information, clarify content, and facilitate document finalization.
- Ensure all documents comply with applicable global regulatory guidelines (e.g., ICH, GCP, FDA, EMA), internal company standards, and publication ethics.
- Manage multiple writing projects simultaneously, prioritizing tasks, setting realistic timelines, and consistently adhering to aggressive deadlines and stringent quality standards.
- Participate actively in team meetings, provide strategic input on document content, messaging, and overall communication plans.
- Conduct thorough literature searches and leverage scientific expertise to support document development and ensure scientific accuracy.
- Act as a subject matter expert in medical writing, potentially mentoring junior writers and contributing to the development of best practices and standard operating procedures within the department.
Required Skills
- Minimum of 3-5 years of experience in medical writing within the pharmaceutical, biotechnology, or contract research organization (CRO) industry.
- Proven ability to write and edit complex scientific and clinical documents for regulatory submissions and scientific publications.
- Excellent understanding of clinical research, drug development processes, and global regulatory requirements (e.g., ICH, GCP, FDA, EMA).
- Exceptional written and verbal communication skills, with keen attention to detail, grammar, style, and scientific accuracy.
- Proficiency in medical terminology and scientific concepts across various therapeutic areas.
- Strong organizational and project management skills, with the ability to manage multiple priorities effectively in a fast-paced environment.
- Advanced proficiency with Microsoft Office Suite (Word, Excel, PowerPoint) and experience with electronic document management systems.
Preferred Qualifications
- Advanced degree (PhD, PharmD, MD, or Master's in a relevant scientific discipline).
- Experience in specific therapeutic areas such as Oncology, Cardiovascular, Renal & Metabolism, or Respiratory & Immunology.
- Prior experience with electronic publishing tools and submission-ready documents.
- Certification from a professional medical writing association (e.g., AMWA, EMWA).
- Experience with global regulatory submissions (e.g., NDA/BLA, MAA).
Perks & Benefits
- Competitive salary and performance-based bonuses.
- Comprehensive health, dental, and vision insurance plans for employees and their families.
- Generous paid time off, including vacation, sick leave, and company holidays.
- 401(k) retirement plan with robust company match.
- Opportunities for professional development, continuous training, and career advancement within a global organization.
- Life and disability insurance coverage.
- Employee assistance programs and comprehensive wellness initiatives.
- Access to a vibrant and collaborative work environment located in the scenic Mizner Park area.
- Flexible work options, fostering work-life balance.
How to Apply
To express your interest in this exciting opportunity and to contribute to AstraZeneca’s mission of delivering life-changing medicines, please click on the application link below. We encourage you to submit a detailed resume and a compelling cover letter outlining your experience, qualifications, and how you can contribute to the Medical Writer role at AstraZeneca. We look forward to reviewing your application and exploring how your skills can make a significant impact.