This position is accountable for the timely preparation of high-quality regulatory compliant clinical document deliverables for Alexion Rare Disease Unit (Alexion). This position will support the medical writing (MW) activities for one or more clinical programs. This position will function with supervision and guidance from experienced managers or colleagues.

Typical Accountabilities
- Lead and provide technical and scientific expertise for clinical or post marketing safety projects, process improvements, and departmental initiatives, including providing dotted-line or informal people leadership and ownership of small teams or project groups
- Manage and develop a patient safety team, guiding performance, supporting professional growth, and overseeing day-to-day activities - Actively contribute to the development and execution of country, regional, or sub-functional patient safety strategies, ensuring alignment with organizational goals, and lead cross-functional and, where relevant, cross-country/region projects, serving as a bridge between subject matter expert and formal people leader - Serve as a knowledge resource by sharing best practices, mentoring colleagues, and driving cross-functional collaboration within and beyond the team - Support or oversee compliance with patient safety policies and regulations, ensuring thorough review and accuracy of safety documentation and submissions - Apply analytical expertise to inform key decisions, drive reporting and quality initiatives, and contribute to continuous improvement efforts

Qualifications and Skills
- Bachelor’s degree in a relevant scientific or healthcare discipline (or proven patient safety experience equivalence in a similar role); advanced degree preferred;
- Experience in patient safety within pharmaceutical, hospital, clinical research, or healthcare settings (including Specialist roles within AstraZeneca Patient Safety)

- Thorough knowledge of patient safety processes and local regulations (e.g., FDA and ICH regulations relevant to patient safety and adverse event reporting); broad competence with medical, therapeutic, and technical terminology

- Ability to work effectively as part of a cross-functional team; excellent verbal and written communication skills

- Assumes a supporting role in identifying patient safety-related issues and implementing solutions; supports business unit needs and patient safety by developing and maintaining partnerships with internal and external customers.

Desirable:

- Excellent knowledge of AstraZeneca policies, procedures, and guidelines; provides training and mentoring to Patient Safety Coordinators on local and global adverse event reporting and career development

- Actively pursues continuing education within the Pharmaceutical Industry; proven ability to perform with some supervision

- Works as a team player and supports the development of other team members; supports the interview process for prospective new team members.

At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives. 

Ready to lead and inspire? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease. 

#LI-Hybrid

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AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs.  In some cases, offers outside the range may also be considered to address unique circumstances.

In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role).  Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.