Regulatory Medical Writing Director

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

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.