Associate Director Medical Writing Operations

Associate Director Medical Writing Operations

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire lifechanging medicines. Inperson working gives us the platform to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were 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 highquality regulatorycompliant documents that support clinical development within the Alexion RDU clinical portfolio. The position encompasses managing and facilitating crossfunctional 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 uptodate 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 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 presubmission 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 technologyrelated 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 teambased environment.
• Welldeveloped 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.

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Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment training compensation promotion and other terms and conditions of employment based on race color religion creed or lackthereof sex sexualorientation age ancestry national origin ethnicity citizenship status marital statuspregnancy (including childbirth breastfeeding or related medical conditions) parental status (including adoption or surrogacy) military status protected veteran status disability medical condition gender identity or expression genetic information mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin aninteractive dialogue with Alexion regarding an accommodation please contact . Alexion participates in EVerify.