Director, Medical Writing

AstraZeneca; Mississauga; Hybrid; CAD 120,000 - 160,000; Full time

Job summary

A leading biopharmaceutical company in Peel Region is seeking an experienced Director of Medical Writing to manage the creation of high-quality clinical regulatory documents. You will play an essential role in developing regulatory submissions and mentoring a talented team. The position requires a PhD or MS in life sciences and at least 10 years of relevant experience. The company offers flexible health benefits and a great work-life balance.

Benefits

Flexible Health Benefits

Retirement Savings

Tuition assistance support

Minimum of 4 weeks paid vacation

Qualifications

• At least 10 years of clinical regulatory medical writing experience, expertise in global clinical trials.
• Exceptional oral and written communication abilities, proficiency in MS Office.
• Deep understanding of global regulatory requirements and ICH/GCP guidelines.
• Proven experience leading and mentoring medical writers.

Responsibilities

• Drive the development and execution of document strategies for regulatory submissions.
• Collaborate on developing briefing packages and responses to health authority inquiries.
• Author and ensure outstanding medical writing deliverables.

Skills

Clinical regulatory medical writing experience

Oral and written communication skills

Regulatory knowledge

Leadership abilities

Project management skills

Education

PhD or MS in life sciences or equivalent

Job description

Empower the Future of Medicine at Alexion, AstraZeneca Rare Disease!

Join our passionate team at Alexion and contribute to our mission of delivering life-transforming therapies to patients with rare diseases. We are seeking an experiencedDirector, Medical Writingto drive the creation of high-quality clinical regulatory documents and support the development of our clinical portfolio.

Your Impact:

As a pivotal member of our team, you will:

• Strategize and Lead: Drive the development and execution of document strategies for regulatory submission, ensuring the highest quality of filing submission documents (Mod 2 Clinical Summaries, Clinical Overviews), clinical study protocols, reports, and Investigator's Brochures.

• Collaborate and Contribute: Play a key role in developing briefing packages and responses to health authority inquiries, contributing to global regulatory submission documents.

• Ensure Excellence: Author and run outstanding medical writing deliverables, guaranteeing scientific accuracy, clarity, and compliance with regulatory and internal guidelines.

• Communicate Consistently: Support the development of uniform messaging across all submission documents, including nonclinical, clinical, and product labeling.

• Mentor and Direct: Mentor and Direct medical writing team members to ensure efficiency and quality in document production.

• Innovate and Collaborate: Develop effective partnerships within Alexion and with external team members to maintain adherence to industry standards and regulatory requirements.

What You Bring to the Table:

• Experience: At least 10 years of clinical regulatory medical writing experience, with global clinical trials and regulatory submissions expertise.

• Communication Skills: Exceptional oral and written communication abilities, with proficiency in MS Office.

• Regulatory Knowledge: A deep understanding of global regulatory requirements and ICH/GCP guidelines.

• Leadership: Proven experience leading and mentoring medical writers and fostering the development of junior staff.

• Professional Ethics: A strong sense of responsibility, ethics, and respect for others.

• Work Environment: Ability to work in an office environment, using computers and participating in communication and collaborative activities during standard business hours.

Preferred Qualifications:

• Education: PhD or MS degree in life sciences or an advanced degree or equivalent experience in a relevant field.

• Relationship Building: Outstanding skills in establishing internal and external relationships, including with alliance partners and vendors.

• Project Management: Proficiency in planning, budgeting, and project management, coupled with strong problem-solving and negotiation skills.

• Specialized Experience: Knowledge of rare and ultra-rare diseases is highly advantageous.

• Drive and Excellence: A results-driven mindset with a dedication to high standards of excellence.

What we offer:

• Flexible Health Benefits: a flexible benefits program for comprehensive health and dental care. Our extended benefits include prescription drugs, vision care, fertility treatment, support for gender affirmation procedures as well as other health and mental health options. We uphold work-life balance policies, and offer resources like Teledoc Health, giving employees and their families access to top medical experts.

• Retirement Savings: Employees receive an automatic employer Pension contribution and can contribute to the Optional Savings Plan, which attracts an additional company match. Opportunities to contribute to a Stock Purchase Plan as well as a TFSA are also available.

• Flexible Extras: We offer extras to support employees and the big moments in life. From great maternity, parental and adoption leave support, to increased paid bereavement days, and our 12-week top-up for conscientious and critical illness leave, we look after our people. We also encourage continuing education through employee tuition assistance support

• Vacation: a minimum of 4 weeks of paid vacation, pro-rated to your date of hire.

Why Join Us?

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.

AstraZeneca 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 believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We align with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

#LI-Hybrid

Date Posted

25-Nov-2025

Closing Date

08-Dec-2025

Alexion is proud to be an Equal Employment Opportunity and affirmatively action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexualorientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact [e-mail]. Alexion participates in E-Verify.