Job Overview:
We are seeking an experienced Medical Writer to lead our medical writing activities across a disease area or set of clinical programs. This position is accountable for the timely delivery of high-quality clinical regulatory documents supporting our clinical development portfolio.
Key Responsibilities:
* Develop and implement document strategy for clinical regulatory submission documents and other clinical documents, including clinical study protocols, clinical study reports, Investigator's Brochures, and clinical Common Technical Document components
* Contribute to the development of briefing packages, responses to health authority inquiries, and other IND/CTA or global regulatory submission documents
* Support clinical project teams by authoring and managing high-quality MW deliverables in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes
* Represent MW cross functionally, negotiating timelines as necessary
* Support consistent messaging across all submission documents (nonclinical, clinical, and product labeling)
Required Skills and Qualifications:
* Excellent oral, written, and presentation skills; advanced user of MS Office suite
* Thorough knowledge of global regulatory requirements and ICH/GCP guidelines
* Demonstrated aptitude for managing the work of external and/or internal medical writers, as well as training and fostering development of less experienced staff
* Well-developed sense of ethics, responsibility, and respect for others
Benefits:
* Astra Zeneca embraces diversity and equality of opportunity
* We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills
* We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics