Associate Director, Medical Writing
This is what you will do:
This position is accountable for the timely preparation of high-quality clinical regulatory documents supporting the clinical development portfolio at Alexion. This position will lead the medical writing (MW) activities across a disease area or set of clinical programs. This position will function with limited supervision as required.
You will be responsible for:
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 (eg, Module 2 summaries). Contribute to the development of briefing packages, responses to health authority inqueries, pediatric investigational plans, and other IND/CTA or global regulatory submission documents.
Support clinical project teams by authoring and managing high-quality MW deliverables in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes. Represent MW cross-functionally, negotiating timelines as necessary.
Support development and implementation of strategy for writing and completion of high-quality clinical documents.
Participate with other MW 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 MW team members (internal and external), ensuring quality and efficiency in the production of clinical regulatory documents.
You will need to have:
At least 5-7 years of clinical regulatory MW experience, including global clinical studies and regulatory submissions. Will consider fewer years of MW experience combined with other relevant pharmaceutical industry experience.
Proven capability to write clinical study documents (eg, 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 .
We would prefer for you to have:
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 .
Agile learner with ability to work both collaboratively and independently, seeking advice as required.
Alexion Canada
Since beginning our operations in Canada in 2009, Alexion has been working tirelessly to bring innovative medicines to the millions of Canadians living with rare diseases. Our pioneering 30-year legacy, our scientific expertise and our commitment to patient-centric decision-making are the foundations of what we are today – a company with a mission to transform lives.
Our Canadian team
We know that people living with a rare disease and their families deserve our unwavering commitment and investment into finding and accessing therapies that help them live longer, fuller lives. Our presence in Canada has grown to over 200 employees and includes a global research and development hub, made up of highly skilled professionals responsible for conducting our clinical trials in Canada and around the world, as well as our dedicated and passionate local teams that ensures our treatments reach those who need them. Together, we are driving patient impact locally and globally.
How we work
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.
Alexion 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 comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. Alexion is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.
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 comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.