Director, Medical Writing

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.

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.

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.

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.