Associate Director, Medical Writing (6 - Month Contract)

AstraZeneca•Mississauga, ON

5d•CA$128,488 - CA$168,641•Hybrid

About The Position

This is a 6-Month Contract. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. Introduction to role: Are you ready to lead the charge in crafting high-quality clinical regulatory documents that drive the clinical development portfolio at Alexion? As an Associate Director of Medical Writing, you'll spearhead medical writing activities across disease areas or clinical programs, ensuring timely and precise documentation. With limited supervision, you'll be at the forefront of transforming complex scientific data into clear, impactful narratives.

Requirements

Clinical regulatory medical writing experience, including global clinical studies and regulatory submissions.
Will consider less medical writing experience combined with other relevant pharmaceutical industry experience.
Demonstrated capability to write clinical study documents (e.g., clinical study protocols, clinical study reports, Investigator's Brochures, and Module 2 summaries).
Excellent oral, written, and presentation skills; advanced user of MS Office suite.
Thorough knowledge of global regulatory requirements and ICH/GCP guidelines.
Skilled at project management, with emphasis on time management, organization, and negotiation.
Committed to achieving results; sets high standards for oneself and others.

Nice To Haves

PhD or MS degree in life sciences or advanced degree in a relevant scientific/clinical/regulatory field.
Experience with global clinical studies and regulatory submissions.
Ability to establish excellent internal and external relationships, including alliance partners and vendors.
Supportive teammate who shines in a collaborative environment.
Well-developed sense of ethics, responsibility, and respect for others.
Agile learner with ability to work both collaboratively and independently, seeking advice as required.
High level of flexibility and ability to innovate and adapt to changing conditions.

Responsibilities

Author and manage the completion of clinical documents including clinical study protocols and amendments, clinical study reports, Investigator's Brochures and updates, and clinical Common Technical Document components (e.g., Module 2 summaries).
Contribute to the development of briefing packages, responses to health authority inquiries, pediatric investigational plans, and other IND/CTA or global regulatory submission documents.
Support clinical project teams by authoring and managing high-quality medical writing deliverables in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes.
Represent medical writing cross-functionally, negotiating timelines as necessary.
Support development and implementation of strategy for writing and completion of high-quality clinical documents.
Participate with other medical writing team members to develop and implement process and standards and take responsibility for execution in cross-functional teams.
Maintain adherence to standard operating procedures and regulatory requirements in partnership with statistical, clinical, regulatory, quality, and drug safety colleagues.
Develop effective collaborations with other functional lines within Alexion, and externally with regulatory, industry, professional, and academic organizations.
Review, edit, and ensure quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensure adherence to standards.
Mentor less experienced medical writing team members (internal and external), ensuring quality and efficiency in the production of clinical regulatory documents.