Senior Manager, Medical Writing Operations
at
Alexion Pharmaceuticals, Inc.
Senior Manager, Medical Writing Operations
Company
Alexion Pharmaceuticals, Inc.
Location
Mississauga, Ontario, Canada
Date Posted
December 25, 2024
**Job Title:** Medical Writing & Clinical Trial Transparency (MW&CTT) Support
**Company:** Alexion
**Location:** [Insert Location]
**Overview:**
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. Our goal is to ensure Alexion’s continued compliance with relevant laws, policies, regulations, and public commitments for visibility and disclosure.
**Key Responsibilities:**
- Support and facilitate operational processes across Medical Writing (MW), including vendor management and technology implementation.
- Contribute industry experience to support innovation projects within MW.
- Track MW deliverables, confirming up-to-date document attributes, budgets, and resourcing.
- Develop strategies to integrate vendor support, ensuring optimal project performance within defined timelines, budgets, and quality standards.
- Stay informed of current technological tools for document development/management, aiding in process improvement and troubleshooting.
- Ensure adherence to relevant regulatory, technical, and quality standards, applying best practices.
- Manage multiple tasks across several drug projects, delivering on priorities effectively.
- Ensure clarity, accuracy, and consistency of scientific content.
- Collaborate proactively with other functions and external service providers.
- Maintain knowledge of regulatory, industry, and medical writing best practices for continuous improvement.
**Essential Skills/Experience:**
- Life Sciences degree or equivalent
- Experience in regulatory documentation and/or medical communications
- Operational experience in the pharmaceutical industry
- Knowledge of technical and regulatory requirements relevant to the role
**Working Environment:**
We promote in-person collaboration, averaging a minimum of three days per week in the office, while respecting individual flexibility. Our dynamic environment fosters bold thinking and innovation.
**Join Us:**
Explore rare opportunities at Alexion where we push the boundaries of science to translate complex biology into transformative medicines. If you are ready to make a difference, apply now!