Associate Director, Medical Writing Operations

Job title:

Associate Director, Medical Writing Operations

Company

Alexion Pharmaceuticals

Job description

Associate Director, Medical Writing OperationsWhen 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.This role is responsible for overseeing the operational aspects of the Medical Writing and Clinical Trial Transparency (MW CTT) department, ensuring the timely delivery of high-quality, regulatory-compliant documents that support clinical development within the Alexion RDU clinical portfolio. The position encompasses managing and facilitating cross-functional operational processes within MW, including vendor management, technology implementation and maintenance, and the updating and maintenance of standard operating procedures. Additionally, the role involves contributing industry expertise to support innovation projects within MW.You will be responsible for:

• Providing oversight and tracking of all medical writing (MW) deliverables, including confirmation of up-to-date document attributes and timing, budgets, and resourcing.
• Collaborating closely with the MW Team to promote standard methodologies and provide support for operational excellence, innovation, capabilities, efficiency, resourcing, and operational practices.
• Developing strategies for and managing execution of external support for the internal team with Contract Research Organizations (CROs) or other external resources, including oversight of performance management for vendors who provide medical writing services (eg, writing, QC, formatting, pre-submission publishing).
• Supporting vendor project resource forecasting and tracking, budget forecasting and accrual, contract negotiation in collaboration with Global Strategic Sourcing, and project metrics to ensure vendor projects perform with maximum efficiency within established timelines, budgets, and quality standards.
• Collaborating with MW Team members to ensure operational support for clinical project teams, including document and process quality checks, and technical/operational tools supporting MW deliverables.
• Staying updated on the latest technological tools for document development/management, using new advancements to improve MW processes, and addressing technology-related issues within MW.
• Maintaining MW standard operating procedures.
• Implementing and supporting brand new, groundbreaking medical writing standards, tools, and systems.

Qualifications:

• Advanced degree or equivalent strongly preferred.
• At least 5 -10 years of regulatory medical writing management and operational experience or other relevant pharmaceutical industry experience, combined with scientific, technical, and regulatory knowledge, to support MW function.
• Demonstrated ability to manage excellent internal and external relationships, including alliance partners and vendors; experience managing CRO relationships.
• Thorough knowledge of global regulatory requirements and ICH/GCP guidelines.
• Proven experience in operational strategy; experience with developing, implementing, and measuring the impact of MW processes and systems across multiple projects.
• Excellent communication, planning and organizational skills.
• Experience with MW deliverables, process, and technologies supporting global clinical studies and regulatory submissions.
• Excellent project management, planning, and budgeting skills.
• Extensive technical skills including proficiency in MS Project, MS Word, Adobe Acrobat, and electronic repositories.
• Team player and leader who thrives in a team-based 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.

At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients’ lives.Ready to lead and inspire? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease.#LI-HybridAstraZeneca 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.

Expected salary

Location

Mississauga, ON

Job date

Wed, 26 Mar 2025 23:23:59 GMT

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