Senior Manager, Medical Writing Operations
“AstraZeneca Canada offices will be closed from December 25th to January 1st, re-opening January 2nd. We encourage you to apply to jobs of interest and we will review applications upon our return.”
To support Alexion’s mission to improve the lives of people affected by rare diseases, the Medical Writing & Clinical Trial Transparency (MW&CTT) team drives the development of strategic and compliant documents to enable clinical research and regulatory approval of new therapies, and ensures Alexion’s continued compliance with laws, policies, regulations, and public commitments for visibility and disclosure. The Alexion Medical Writing (MW) team provides expert leadership and strategic authoring of high-quality clinical, nonclinical regulatory documents. Alexion MW&CTT supports the Company’s core therapeutic areas in all phases of clinical development.
Accountabilities:
- Support and facilitate operational processes across MW, including management support of vendors; recommendation, implementation, and maintenance of technology; and contribute industry experience to support innovation projects across MW.
- Support MW deliverable tracking, including confirmation of up-to-date document attributes and timing, budgets, and resourcing.
- Support strategies to augment the internal team with vendor support and contribute to vendor oversight and project metrics to ensure vendor projects perform with maximum efficiency within established timelines, budgets, and quality standards.
- Support maintenance of up-to-date knowledge of the latest technological document development/management tools to develop strategies to better support MW process improvement and troubleshoot/escalating technology-related issues within MW.
- Ensure that relevant regulatory, technical, and quality standards are achieved, and that relevant processes and best practice are applied.
- Have the ability to balance multiple tasks in parallel, potentially across several drug projects, and deliver on priorities.
- Ensure strategic organization, clarity, accuracy, format, and consistency of scientific content.
- Proactively collaborate with other functions, including, as needed, with external service providers/contractors.
- Develop effective collaborations with other functional lines within Alexion, and keep abreast of regulatory, industry, and medical writing knowledge and best practice.
- Strive for continuous improvement and operational excellence from a communications leadership perspective, including representing Alexion MW.
Essential Skills/Experience:
- Life Sciences degree or equivalent
- Experience in regulatory documentation and/or medical communications
- Medical writing Operations experience in the pharmaceutical industry
- Knowledge of the technical and regulatory requirements related to the role
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 we need 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.
Explore rare opportunities at Alexion. Rare disease biopharma is at the forefront of biomedical science. Remaining transparent, objective and ethical, we push the boundaries of science, translating complex biology into transformative medicines. Uniquely positioned – with resources and global reach – we also have potent capabilities that are shaping the future of Rare disease into new areas of great unmet need to help people fully live their best lives.
Ready to make a difference? Apply now!
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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.